63. Idiopathic thrombocytopenic purpura Clinical trials / Disease details
Clinical trials : 363 / Drugs : 212 - (DrugBank : 43) / Drug target genes : 47 - Drug target pathways : 138
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04812483 (ClinicalTrials.gov) | May 2022 | 1/3/2021 | Immunomodulation With Eltrombopag in ITP | Immunomodulation in Young Adults With Newly Diagnosed Primary Immune Thrombocytopenia (ITP): A Randomized Open Label Trial With High-dose Dexamethasone Versus Eltrombopag and High-dose Dexamethasone | Primary Immune Thrombocytopenia (ITP) | Drug: Eltrombopag (Revolade®);Drug: standard therapy (without eltrombopag): HD-DXM | University Children's Hospital Basel | Stiftung zur Förderung medizinischer und biologischer Forschung;Novartis Pharmaceuticals;University of Erlangen-Nürnberg, Department of Biology | Recruiting | 18 Years | 45 Years | All | 24 | Phase 2 | Switzerland |
| 2 | ChiCTR2000040991 | 2022-03-02 | 2020-12-16 | Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study | Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study | primary immune thrombocytopenia | experimental group:Cyclosporine A combined with eltrombopag; | The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Recruiting | 18 | 75 | Both | experimental group:28; | Phase 4 | China |
| 3 | EUCTR2021-002897-19-HU (EUCTR) | 02/03/2022 | 23/12/2021 | A Phase 2 Open-Label Safety and Efficacy Study of PF-06835375 in adult participants with Immune thrombocytopenia, a disorder in which there is a reduced amount of platelets in the blood stream which are important for blood to clot normally | AN INTERVENTIONAL PHASE 2, OPEN-LABEL, ONE-ARM, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA - A Phase 2 Open-Label Safety and Efficacy Study of PF-06835375 | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: PF-06835375 Product Code: PF-06835375 INN or Proposed INN: not available Other descriptive name: PF-06835375 | Pfizer Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 2 | United States;Czechia;Hungary;Canada;Poland;Australia | ||
| 4 | NCT05232149 (ClinicalTrials.gov) | February 2022 | 20/12/2021 | A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia | A Randomized, Multi-center, Adaptive Phase IIa/IIb Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Persistent or Chronic Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Drug: Orelabrutinib( lower dose);Drug: Orelabrutinib( higher dose) | Beijing InnoCare Pharma Tech Co., Ltd. | NULL | Not yet recruiting | 18 Years | 80 Years | All | 30 | Phase 2 | China |
| 5 | NCT05070845 (ClinicalTrials.gov) | January 31, 2022 | 27/9/2021 | Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia | AN INTERVENTIONAL PHASE 2, OPEN-LABEL, ONE-ARM, MULTI-CENTER STUDY TO EVALUATE SAFETY AND EFFICACY OF PF-06835375 IN ADULT PARTICIPANTS WITH MODERATE TO SEVERE PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia | Biological: PF-06835375 | Pfizer | NULL | Not yet recruiting | 18 Years | 70 Years | All | 40 | Phase 2 | United States;Poland |
| 6 | EUCTR2020-004032-21-DK (EUCTR) | 11/01/2022 | 16/04/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Denmark;Peru;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 7 | NCT04812925 (ClinicalTrials.gov) | November 17, 2021 | 15/3/2021 | A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Biological: efgartigimod PH20 SC | argenx | NULL | Recruiting | 18 Years | N/A | All | 156 | Phase 3 | United States;Australia;Japan;Russian Federation |
| 8 | NCT03692754 (ClinicalTrials.gov) | November 1, 2021 | 29/9/2018 | Atorvastatin in Management of Newly Diagnosed ITP | A Single-center Prospective Randomized Study of Atorvastatin in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia;Purpura, Thrombocytopenic | Drug: Atorvastatin 20mg;Drug: Atorvastatin 10mg;Drug: Dexamethasone | Shandong University | NULL | Not yet recruiting | 18 Years | 80 Years | All | 30 | Phase 2/Phase 3 | China |
| 9 | NCT05029635 (ClinicalTrials.gov) | October 1, 2021 | 8/8/2021 | Phase III Study on HMPL-523 for Treatment of ITP | A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HMPL-523 in Treatment of Primary Immune Thrombocytopenia (ITP) in Adults | Immune Thrombocytopenia (ITP) | Drug: HMPL-523;Drug: Placebo | Hutchison Medipharma Limited | NULL | Not yet recruiting | 18 Years | 75 Years | All | 177 | Phase 3 | NULL |
| 10 | NCT05220878 (ClinicalTrials.gov) | September 9, 2021 | 21/1/2022 | Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With Chronic ITP | Multicenter Randomized Double-blind Comparative Study of Clinical Efficacy and Safety of GNR-069 (JSC GENERIUM, Russia) and Nplate (Amgen Europe BV, The Netherlands) in Patients With Chronic Idiopathic Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Biological: GNR-069;Biological: Nplate | AO GENERIUM | NULL | Recruiting | 18 Years | 75 Years | All | 160 | Phase 3 | Russian Federation |
| 11 | EUCTR2019-000884-26-HR (EUCTR) | 09/09/2021 | 24/11/2021 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Georgia;Bulgaria;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 12 | EUCTR2020-004033-20-NO (EUCTR) | 08/09/2021 | 20/04/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 13 | EUCTR2020-004033-20-GR (EUCTR) | 07/09/2021 | 19/07/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 14 | EUCTR2020-004033-20-BG (EUCTR) | 03/09/2021 | 26/05/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 15 | EUCTR2020-004033-20-PT (EUCTR) | 03/09/2021 | 20/05/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 16 | NCT05020288 (ClinicalTrials.gov) | September 1, 2021 | 12/8/2021 | A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP | A Prospective, Open-label, Multicenter,Single-armed Study of Orelabrutinib in the Treatment of Refractory Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia;Bruton's Tyrosine Kinase | Drug: Orelabrutinib | Shandong University | NULL | Not yet recruiting | 18 Years | 70 Years | All | 40 | Phase 2 | NULL |
| 17 | JPRN-jRCT2031210245 | 31/08/2021 | 16/08/2021 | A study to investigate the long-term safety, tolerability, and efficacy of rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - TP0004 | Primary immune thrombocytopenia | Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Periods. Study participants will receive fixed-unit doses of rozanolixizumab across body weight tiers. | Sugihara Kazuhiro | NULL | Recruiting | >= 18age old | Not applicable | Both | 10 | Phase 3 | Austria;Belgium;Bulgaria;Canada;China;Czechia;France;Georgia;Germany;Hong Kong;Hungary;Italy;Republic of Moldova;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom;United States;Japan |
| 18 | NCT05023915 (ClinicalTrials.gov) | August 21, 2021 | 21/8/2021 | A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP | High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial | Immune Thrombocytopenia | Drug: dexamethasone;Drug: diammonium glycyrrhizinate enteric-coated capsule | Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 106 | Phase 2 | China |
| 19 | EUCTR2020-004033-20-ES (EUCTR) | 13/08/2021 | 09/06/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 20 | EUCTR2020-004033-20-IT (EUCTR) | 23/07/2021 | 17/08/2021 | Study to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC+ | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC Product Code: [ARGX-113] INN or Proposed INN: efgartigimod alfa | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 21 | EUCTR2020-004032-21-PT (EUCTR) | 19/07/2021 | 11/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 22 | EUCTR2020-004032-21-NO (EUCTR) | 25/06/2021 | 18/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Serbia;Portugal;Taiwan;Greece;Thailand;Spain;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Jordan;Denmark;Australia;Peru;South Africa;Tunisia;Latvia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 23 | EUCTR2019-003451-11-DK (EUCTR) | 17/06/2021 | 19/04/2021 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Serbia;United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China | ||
| 24 | EUCTR2020-004032-21-DE (EUCTR) | 15/06/2021 | 12/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 25 | EUCTR2020-004032-21-IT (EUCTR) | 04/06/2021 | 08/06/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH20 Subcutaneous in adult patients with primary immune thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 22.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC Product Code: [ARGX-113] INN or Proposed INN: efgartigimod alfa | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 26 | NCT04890041 (ClinicalTrials.gov) | May 30, 2021 | 12/5/2021 | Avatrombopag in Primary Immune Thrombocytopenia (ITP) in Adults | Efficacy and Safety of Avatrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults With Poor Efficacy of Eltrombopag or rhTPO: a Single-center, Prospective, One-arm Study | Primary Immune Thrombocytopenic Purpura | Drug: Avatrombopag | Institute of Hematology & Blood Diseases Hospital | NULL | Recruiting | 18 Years | N/A | All | 20 | N/A | China |
| 27 | EUCTR2019-000884-26-GR (EUCTR) | 25/05/2021 | 01/04/2021 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 28 | JPRN-jRCT2071210025 | 25/05/2021 | 24/05/2021 | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary Immune Thrombocytopenia | Patients will receive ARGX-113 PH20 SC (1000 mg of Efgartigimod Alfa) or placebo PH20 SC, weekly from visits 1 to 4 and then from visits 5 to 16 either weekly or biweekly, adjusted according to their platelet count. From visits 17 to 24, patients will be fixed on the dosing schedule they were receiving at visit 16 or the last visit at which IMP was administered (i.e. either weekly or biweekly). | Gandini Domenica | NULL | Recruiting | >= 20age old | Not applicable | Both | 9 | Phase 3 | Denmark;France;Georgia;Germany;Greece;Ireland;Israel;Italy;Jordan;Republic of Korea;Latvia;Mexico;New Zealand;Norway;Peru;Poland;Portugal;Romania;Russian Federation;Serbia;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;United Kingdom;United State;Japan;Argentina;Australia;Bulgaria;Chile;China;Colombia |
| 29 | EUCTR2020-004032-21-BG (EUCTR) | 17/05/2021 | 15/03/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Australia;Peru;Denmark;South Africa;Latvia;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | ||
| 30 | EUCTR2020-004032-21-IE (EUCTR) | 07/05/2021 | 17/02/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Portugal;Serbia;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Germany;Norway;Japan;New Zealand | ||
| 31 | EUCTR2019-000883-40-DE (EUCTR) | 09/04/2021 | 10/09/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United States;Serbia;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Moldova, Republic of;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Canada;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 32 | EUCTR2019-002101-21-AT (EUCTR) | 22/03/2021 | 24/11/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 33 | EUCTR2020-003232-24-DE (EUCTR) | 11/03/2021 | 27/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Dova Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | France;United States;Czechia;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 34 | NCT04949009 (ClinicalTrials.gov) | March 1, 2021 | 13/5/2021 | Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP) | Avatrombopag in the Treatment of Primary Immune Thrombocytopenia(ITP): a Single-arm, Multi-centre, Observational Study | Primary Immune Thrombocytopenia | Drug: Avatrombopag | Shandong University | NULL | Recruiting | 18 Years | N/A | All | 400 | China | |
| 35 | EUCTR2019-004103-12-DE (EUCTR) | 22/02/2021 | 02/04/2020 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: TAK-079 INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 | Takeda Development Center Americas, Inc. (Takeda) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine;Croatia;Bulgaria;Germany;Italy | ||
| 36 | NCT04737850 (ClinicalTrials.gov) | February 2021 | 17/1/2021 | Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia | Safety and Efficacy of Hetrombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia:a Randomized, Multicenter, Placebo-controlled Trial | Immune Thrombocytopenia | Drug: Hetrombopag;Drug: Placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Not yet recruiting | 6 Years | 17 Years | All | 117 | Phase 3 | China |
| 37 | ChiCTR2000039630 | 2021-01-01 | 2020-11-03 | Phase II clinical trial of the superiority of montelukastine in combination with TPO-MPL agonists for the treament of primary immune thrombocytopenia | Phase II clinical trial of the superiority of montelukastine in combination with TPO-MPL agonists for the treament of primary immune thrombocytopenia | Primary immune thrombocytopenia | experimental group:Montelukast sodium 10mg/day; rhTPO 15000 units;control group:rhTPO 15000 units; | Department of Hematology, Second Medical Center, Chinese PLA General Hospital | NULL | Recruiting | 14 | 80 | Both | experimental group:51;control group:51; | Phase 2 | China |
| 38 | NCT04596995 (ClinicalTrials.gov) | December 30, 2020 | 15/10/2020 | A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia | Drug: Rozanolixizumab | UCB Biopharma SRL | NULL | Enrolling by invitation | 18 Years | N/A | All | 180 | Phase 3 | Georgia;Germany;Hungary;Italy;Japan;Moldova, Republic of;Poland;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom |
| 39 | EUCTR2020-003232-24-PL (EUCTR) | 29/12/2020 | 28/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Sobi, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | United States;France;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 40 | EUCTR2019-002101-21-GB (EUCTR) | 16/12/2020 | 29/10/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 41 | EUCTR2019-002101-21-DE (EUCTR) | 15/12/2020 | 26/10/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD Other descriptive name: ARGX-113 | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | Georgia;Bulgaria;Netherlands;United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Germany;Japan | ||
| 42 | EUCTR2019-004103-12-BG (EUCTR) | 15/12/2020 | 22/06/2020 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: TAK-079 INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 | Takeda Development Center Americas, Inc. (Takeda) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine;Croatia;Bulgaria;Germany;Italy | ||
| 43 | NCT04687072 (ClinicalTrials.gov) | December 11, 2020 | 18/12/2020 | A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Biological: Efgartigimod PH20 SC;Other: Placebo PH20 SC | argenx | NULL | Recruiting | 18 Years | N/A | All | 156 | Phase 3 | United States;Argentina;Australia;Bulgaria;Chile;China;Denmark;France;Georgia;Greece;Ireland;Israel;Italy;Japan;Jordan;Korea, Republic of;Mexico;New Zealand;Norway;Poland;Portugal;Romania;Russian Federation;South Africa;Spain;Taiwan;Thailand;Tunisia;Turkey;United Kingdom |
| 44 | EUCTR2019-002101-21-PL (EUCTR) | 09/12/2020 | 15/07/2021 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 45 | EUCTR2020-003232-24-FR (EUCTR) | 03/12/2020 | 02/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Dova Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | United States;France;Hungary;Czech Republic;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 46 | ChiCTR2100045747 | 2020-12-01 | 2021-04-23 | Efficacy and safety study of corticosteroids plus hydroxychloroquine in first-line treatment of patients with primary immune thrombocytopenia with positive antinuclear antibody | Efficacy and safety study of corticosteroids plus hydroxychloroquine in first-line treatment of patients with primary immune thrombocytopenia with positive antinuclear antibody | primary immune thrombocytopenia | Experimental group:hydroxychloroquine + Dexamethasone;Control group:Dexamethasone; | Jinshan Hospital, Fudan University | NULL | Recruiting | 18 | Both | Experimental group:51;Control group:51; | Phase 4 | China | |
| 47 | EUCTR2019-000883-40-BG (EUCTR) | 25/11/2020 | 24/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;China;Japan;Moldova, Republic of | ||
| 48 | EUCTR2020-003232-24-HU (EUCTR) | 11/11/2020 | 20/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Sobi, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | France;United States;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 49 | NCT04278924 (ClinicalTrials.gov) | November 9, 2020 | 19/2/2020 | A Study of TAK-079 in Adults With Persistent/Chronic Primary Immune Thrombocytopenia | A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Persistent/Chronic Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Drug: Placebo;Drug: TAK-079 | Takeda | NULL | Recruiting | 18 Years | N/A | All | 54 | Phase 2 | United States;Bulgaria;Croatia;Germany;Italy;Slovenia;Ukraine |
| 50 | EUCTR2019-000883-40-GB (EUCTR) | 29/10/2020 | 11/09/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 51 | EUCTR2019-004683-22-NO (EUCTR) | 16/10/2020 | 29/04/2020 | Daratumumab as a treatment for adult immune thrombocytopenia | Daratumumab as a treatment for adult immune thrombocytopenia - The DART-study | Immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: daratumumab INN or Proposed INN: DARATUMUMAB Other descriptive name: HUMAX-CD38 | Ostfold Hospital Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Norway | ||
| 52 | EUCTR2019-000883-40-PL (EUCTR) | 09/10/2020 | 25/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 53 | EUCTR2019-000883-40-CZ (EUCTR) | 05/10/2020 | 12/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 54 | EUCTR2019-000883-40-HU (EUCTR) | 29/09/2020 | 11/08/2020 | A study to investigate the long-term safety, tolerability, and efficacy of Rozanolixizumab in study participants with persistent or chronic primary immune thrombocytopenia (ITP) | An Open-Label Extension Study to Investigate the Long-Term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy3 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: Rozanolixizumab | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 210 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 55 | EUCTR2019-004103-12-HR (EUCTR) | 25/09/2020 | 23/11/2020 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: TAK-079 INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 | Millennium Pharmaceuticals, Inc. (Takeda) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine;Croatia | ||
| 56 | EUCTR2019-004103-12-SI (EUCTR) | 16/09/2020 | 28/04/2020 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: TAK-079 INN or Proposed INN: TAK-079 Other descriptive name: TAK-079 | Millennium Pharmaceuticals, Inc. (Takeda) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine;Croatia;Bulgaria;Germany | ||
| 57 | EUCTR2019-003451-11-FR (EUCTR) | 08/09/2020 | 13/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan | ||
| 58 | NCT04917679 (ClinicalTrials.gov) | September 1, 2020 | 1/12/2020 | Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP | Eltrombopag Plus Diacerein vs Eltrombopag in Adult Primary Immune Thrombocytopenia: a Multicenter Randomized Controlled Trial | Thrombocytopenia | Drug: Eltrombopag plus diacerein;Drug: Eltrombopag | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | China |
| 59 | ChiCTR2000035408 | 2020-08-20 | 2020-08-10 | A randomized controlled study for rituximab in first-line treatment of newly diagnosed immune thrombocytopenia | Study of rituximab in first-line treatment of newly diagnosed immune thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Standard dose group:Rituximab (Hanrikang) 375mg/m2, 4 times a week (day 8, 15, 22, 29).;Low-dose group:Rituximab (Hanrikang) 100mg/ time once a week, administered 4 times (day 8, 15, 22 and 29).;Dexamethasone control group:high-dose dexamethasone (HD-DXM), 40mg/d, iv for 4 days (day 1 to day 4), every 15 days, 2 to 4 cycles, until CR or the end of the study.; | Henan Cancer Hospital | NULL | Recruiting | 18 | 65 | Both | Standard dose group:20;Low-dose group:20;Dexamethasone control group:20; | Phase 4 | China |
| 60 | EUCTR2019-003451-11-DE (EUCTR) | 17/08/2020 | 14/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 61 | NCT04518475 (ClinicalTrials.gov) | August 10, 2020 | 12/8/2020 | Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults | A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients | Primary Immune Thrombocytopenia (ITP) | Drug: eltrombopag combining rituximab;Drug: eltrombopag | Institute of Hematology & Blood Diseases Hospital | The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital;Tianjin Medical University Second Hospital;The First Affiliated Hospital of Xiamen University;Nantong University | Recruiting | 18 Years | 60 Years | All | 224 | Phase 4 | China |
| 62 | EUCTR2019-004103-12-IT (EUCTR) | 24/07/2020 | 21/01/2021 | A Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Immune Thrombocytopenia | A Phase II, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Efficacy of TAK-079 in Patients with Persistent/Chronic Primary Immune Thrombocytopenia - / | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: TAK-079 Product Code: [TAK-079] INN or Proposed INN: TAK-079 Product Name: difenidramina Product Code: [NA] INN or Proposed INN: DIFENIDRAMINA CLORIDRATO Other descriptive name: dyphenhydramine hydrochloride Product Name: paracetamolo Product Code: [acetominofene] INN or Proposed INN: PARACETAMOLO Other descriptive name: acetominophen Product Name: metilprednisolone Product Code: [/] INN or Proposed INN: METILPREDNISOLONE Other descriptive name: methylprednisolone | MILLENNIUM PHARMACEUTICALS, INC. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 54 | Phase 2 | United States;Slovenia;Ukraine;Croatia;Bulgaria;Germany;Italy | ||
| 63 | NCT04428255 (ClinicalTrials.gov) | July 21, 2020 | 9/6/2020 | A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP | A Randomized, Double-blind, Placebo-controlled, Phase 2/3 Operational Seamless Designed Clinical Study to Evaluate the Efficacy and Safety of HBM9161 Weekly Subcutaneous Injection in Patients With Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenic Purpura | Drug: HBM9161 Dose A;Drug: HBM9161 Dose B;Drug: Placebo | Harbour BioMed (Guangzhou) Co. Ltd. | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2/Phase 3 | China |
| 64 | JPRN-JapicCTI-205351 | 13/7/2020 | 01/07/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary immune thrombocytopenia | Intervention name : Rozanolixizumab INN of the intervention : rozanolixizumab Dosage And administration of the intervention : Study participants receive rozanolixizumab by subcutaneous infusion at pre-specified time points. Control intervention name : Placebo INN of the control intervention : - Dosage And administration of the control intervention : - | UCB Japan Co., Ltd. | NULL | recruiting | 18 | BOTH | 10 | Phase 3 | Japan, Asia except Japan, North America, Europe | |
| 65 | EUCTR2019-003451-11-AT (EUCTR) | 13/07/2020 | 28/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Germany;Netherlands;China;Japan | ||
| 66 | EUCTR2019-000884-26-AT (EUCTR) | 06/07/2020 | 28/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;Moldova, Republic of;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Belgium;Poland;Croatia;Romania;Georgia;Bulgaria;Japan | ||
| 67 | NCT04274452 (ClinicalTrials.gov) | June 29, 2020 | 14/2/2020 | A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia (ITP) | Biological: efgartigimod;Other: Placebo | argenx | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | United States |
| 68 | EUCTR2019-000884-26-IT (EUCTR) | 09/06/2020 | 17/06/2021 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants with Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Netherlands;Moldova, Republic of;China;Czechia;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Georgia;Bulgaria;Germany;Japan | ||
| 69 | NCT04224688 (ClinicalTrials.gov) | June 3, 2020 | 8/1/2020 | A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma SRL | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 3 | United States;Austria;Belgium;Bulgaria;Canada;China;Czechia;Denmark;France;Germany;Hong Kong;Italy;Poland;Romania;Russian Federation;Spain;Taiwan;Turkey;Ukraine;United Kingdom |
| 70 | NCT04225156 (ClinicalTrials.gov) | June 2, 2020 | 6/1/2020 | A Long-term Study to Assess the Safety and Efficacy of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP). | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia. | Primary Immune Thrombocytopenia | Biological: efgartigimod | argenx | NULL | Active, not recruiting | 18 Years | N/A | All | 101 | Phase 3 | United States;Austria;Belgium;Bulgaria;Czechia;France;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Turkey;Ukraine;United Kingdom |
| 71 | EUCTR2019-003451-11-CZ (EUCTR) | 28/05/2020 | 26/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Taiwan;Hong Kong;Greece;Spain;Ukraine;Russian Federation;Italy;France;Denmark;Netherlands;China;Korea, Republic of;Czechia;Finland;Turkey;Austria;United Kingdom;Czech Republic;Canada;Belgium;Poland;Croatia;Romania;Bulgaria;Germany | ||
| 72 | EUCTR2019-002101-21-NL (EUCTR) | 25/05/2020 | 07/01/2020 | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD Other descriptive name: ARGX-113 | argenx BV | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 73 | EUCTR2019-003451-11-NL (EUCTR) | 22/05/2020 | 03/03/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan;United States;Taiwan | ||
| 74 | EUCTR2019-000884-26-NL (EUCTR) | 22/05/2020 | 03/03/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;Japan;China | ||
| 75 | EUCTR2019-002101-21-IT (EUCTR) | 18/05/2020 | 17/06/2021 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorderthat destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-Label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: [ARGX-113] INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Germany;Netherlands;Japan | ||
| 76 | EUCTR2019-000884-26-FR (EUCTR) | 11/05/2020 | 26/05/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Georgia;Netherlands;Germany;Moldova, Republic of;China;Japan | ||
| 77 | EUCTR2019-002101-21-BG (EUCTR) | 08/05/2020 | 24/04/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 78 | EUCTR2019-002101-21-CZ (EUCTR) | 06/05/2020 | 10/03/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 79 | EUCTR2019-003451-11-IT (EUCTR) | 04/05/2020 | 27/01/2021 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: [UCB7665] INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United States;Czechia;Hong Kong;Taiwan;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;China;Japan | ||
| 80 | ChiCTR2000030603 | 2020-05-01 | 2020-03-08 | Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia | Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia | Primary Immune Thrombocytopenia | The short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine; | The Second Affiliated Hospital of Kunming Medical University | NULL | Pending | 18 | 75 | Both | The short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65; | Phase 4 | China |
| 81 | EUCTR2019-000884-26-BG (EUCTR) | 30/04/2020 | 04/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 82 | EUCTR2019-003451-11-BG (EUCTR) | 30/04/2020 | 04/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Czechia;Taiwan;Hong Kong;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Poland;Romania;Denmark;Bulgaria;Germany;Netherlands;China | ||
| 83 | EUCTR2019-002100-41-AT (EUCTR) | 30/04/2020 | 25/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alpha Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 84 | EUCTR2019-002101-21-BE (EUCTR) | 28/04/2020 | 03/03/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 85 | EUCTR2019-000884-26-CZ (EUCTR) | 23/04/2020 | 25/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Moldova, Republic of;Japan;Korea, Republic of | ||
| 86 | EUCTR2019-003451-11-ES (EUCTR) | 22/04/2020 | 28/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Taiwan;Hong Kong;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Netherlands;Germany;China;Japan | ||
| 87 | EUCTR2019-000884-26-ES (EUCTR) | 22/04/2020 | 28/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 3 | United States;Hong Kong;Taiwan;Greece;Spain;Ukraine;Russian Federation;Italy;France;Netherlands;China;Moldova, Republic of;Austria;United Kingdom;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Croatia;Georgia;Bulgaria;Germany;Japan | ||
| 88 | EUCTR2019-002101-21-FR (EUCTR) | 22/04/2020 | 20/02/2020 | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 89 | EUCTR2019-000884-26-GB (EUCTR) | 20/04/2020 | 16/03/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | Georgia;Bulgaria;Japan;Romania;Croatia;Poland;Belgium;Hungary;Czech Republic;United Kingdom;Austria;Turkey;Finland;Czechia;Korea, Republic of;Moldova, Republic of;Netherlands;Denmark;France;Italy;Russian Federation;Ukraine;Spain;Greece;Taiwan;Serbia;United States | ||
| 90 | EUCTR2019-002100-41-DE (EUCTR) | 14/04/2020 | 25/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alpha Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 91 | EUCTR2019-000884-26-HU (EUCTR) | 13/04/2020 | 11/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Japan;Moldova, Republic of;Korea, Republic of | ||
| 92 | EUCTR2019-002101-21-ES (EUCTR) | 09/04/2020 | 23/01/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 93 | EUCTR2019-002101-21-HU (EUCTR) | 07/04/2020 | 31/01/2020 | A long-term study to assess the safety and efficacy of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Open-label, Long-term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE+ | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 94 | EUCTR2019-003451-11-PL (EUCTR) | 25/03/2020 | 11/02/2020 | A study to assess the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy2 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Serbia;Czechia;Taiwan;Hong Kong;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Canada;Poland;Belgium;Romania;Denmark;Bulgaria;Germany;Netherlands;China | ||
| 95 | EUCTR2019-000884-26-PL (EUCTR) | 20/03/2020 | 03/02/2020 | A study to evaluate the efficacy, safety, and tolerability of rozanolixizumab in adult study participants with persistent or chronic primary immune thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) - myOpportunITy1 | Primary Immune Thrombocytopenia MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Rozanolixizumab Product Code: UCB7665 INN or Proposed INN: ROZANOLIXIZUMAB | UCB Biopharma SRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 3 | United States;Czechia;Taiwan;Greece;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Romania;Croatia;Bulgaria;Georgia;Netherlands;Moldova, Republic of;Japan;Korea, Republic of | ||
| 96 | EUCTR2019-002100-41-CZ (EUCTR) | 20/02/2020 | 08/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 97 | EUCTR2019-002100-41-PL (EUCTR) | 10/02/2020 | 13/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 98 | EUCTR2019-002100-41-IT (EUCTR) | 07/02/2020 | 18/06/2021 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: [ARGX-113] INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | ARGENX BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Japan;Germany;Netherlands;Bulgaria;Georgia;Belgium;Poland;Hungary;France;Italy;United Kingdom;Russian Federation;Austria;Turkey;Ukraine;Spain;Czechia;United States | ||
| 99 | EUCTR2019-002100-41-FR (EUCTR) | 04/02/2020 | 28/10/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Bulgaria;Germany;Netherlands;Japan | ||
| 100 | NCT04200456 (ClinicalTrials.gov) | January 31, 2020 | 13/12/2019 | A Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | A Phase 3 Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia | Drug: Rozanolixizumab;Other: Placebo | UCB Biopharma SRL | NULL | Recruiting | 18 Years | N/A | All | 93 | Phase 3 | United States;Austria;Belgium;Bulgaria;Croatia;Czechia;France;Georgia;Greece;Hungary;Italy;Japan;Korea, Republic of;Moldova, Republic of;Poland;Romania;Russian Federation;Spain;Taiwan;Ukraine;United Kingdom |
| 101 | EUCTR2019-002100-41-BE (EUCTR) | 10/01/2020 | 21/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | Japan;Germany;Netherlands;Bulgaria;Georgia;Belgium;Poland;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Austria;Turkey;Ukraine;Spain;Czechia;United States | ||
| 102 | EUCTR2019-002100-41-GB (EUCTR) | 10/01/2020 | 05/08/2020 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | United States;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Georgia;Germany;Netherlands;Japan | ||
| 103 | NCT04214951 (ClinicalTrials.gov) | January 1, 2020 | 28/12/2019 | A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia | A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia | Corticosteroid-resistant or Relapsed ITP | Drug: Eltrombopag;Drug: Recombinant human thrombopoietin (rh-TPO) | Peking University People's Hospital | NULL | Active, not recruiting | 18 Years | 75 Years | All | 100 | China | |
| 104 | ChiCTR1900027735 | 2020-01-01 | 2019-11-24 | Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) | Clinical study for high-dose dexamethasone combined with versus without human recombinant thrombopoietin (rhTPO) in the treatment of newly diagnosed primary immune thrombocytopenia (ITP) | Adult newly diagnosed immune thrombocytopenia | Study group:Dexamethasone 40mg/d×4d, recombinant human thrombopoietin (rhTPO) 300U/Kg subcutaneous injection, once/d×14d, if PLT>100×109/L or PLT increase =50×109/L during treatment period RhTPO drug was discontinued; rhTPO and dexamethasone were replaced with prednisone 0.5mg~1mg/kg once a day, 0.2mg/kg per week, and the drug was stopped wit;Control group:Dexamethasone 40mg/d×4d, if the PLT>100×10^9/L or PLT increase =50×10^9/L during the treatment period, dexamethasone was replaced with prednisone 0.5mg~ 1mg/kg orally every day, reduce 0.2mg/kg per week, and quickly reduce the dose within 6~8 weeks.; | Department of Hematology, Anhui Provincial Hospital | NULL | Pending | 18 | 80 | Both | Study group:30;Control group:30; | Phase 4 | China |
| 105 | NCT04132050 (ClinicalTrials.gov) | December 24, 2019 | 15/10/2019 | A Clinical Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788 | A Phase III Study in Patients With Chronic Idiopathic Thrombocytopenic Purpura in R788 | Idiopathic Thrombocytopenic Purpura | Drug: R788;Drug: Placebo | Kissei Pharmaceutical Co., Ltd. | NULL | Active, not recruiting | 20 Years | N/A | All | 24 | Phase 3 | Japan |
| 106 | EUCTR2019-002100-41-HU (EUCTR) | 17/12/2019 | 30/10/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 107 | NCT04188379 (ClinicalTrials.gov) | December 16, 2019 | 4/12/2019 | A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP). | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX 113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia (ITP) | Primary Immune Thrombocytopenia | Biological: efgartigimod;Other: Placebo | argenx | NULL | Completed | 18 Years | N/A | All | 131 | Phase 3 | United States;Austria;Belgium;Bulgaria;Czechia;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;Turkey;Ukraine;United Kingdom |
| 108 | EUCTR2019-002100-41-ES (EUCTR) | 16/12/2019 | 11/11/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients with Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: Efgartigimod alfa Other descriptive name: ARGX-113 | argenx BVBA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ukraine;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Bulgaria;Netherlands;Germany;Japan | ||
| 109 | ChiCTR1900027748 | 2019-12-01 | 2019-11-25 | Clinical study of rituximab in the treatment of refractory immune thrombocytopenia | Clinical study of rituximab in the treatment of refractory immune thrombocytopenia | Primary Immune Thrombocytopenia | Case series:Treating with rituximab (hanlikan); | Department of Hematology, the Second Affiliated Hospital of Kunming Medical University | NULL | Pending | Both | Case series:60; | Phase 4 | China | ||
| 110 | ChiCTR1900027753 | 2019-12-01 | 2019-11-25 | Efficacy and safety of cyclosporine and azathioprine in patients with refractory ITP | Efficacy and safety of cyclosporine and azathioprine in patients with refractory ITP | Primary Immune Thrombocytopenia | Group 1:Using cyclosporine A for treatment;Group 2:Using azathioprine for treatment;Control group:Treatment with glucocorticoids; | the Second Affiliated Hospital of Kunming Medical University | NULL | Pending | 18 | 75 | Both | Group 1:30;Group 2:30;Control group:30; | N/A | China |
| 111 | EUCTR2019-002100-41-NL (EUCTR) | 01/11/2019 | 07/08/2019 | A study to assess the efficacy and safety of efgartigimod in adult patients with primary immune thrombocytopenia (an autoimmune disorder that destructs platelets, blood cells that help with clotting, and can lead to easy or excessive bruising and bleeding) | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Efgartigimod (ARGX-113) 10 mg/kg Intravenous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE | Primary immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10050245;Term: Autoimmune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Efgartigimod Product Code: ARGX-113 INN or Proposed INN: EFGARTIGIMOD ALFA Other descriptive name: ARGX-113 | argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | United States;Czechia;Spain;Ukraine;Turkey;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Poland;Belgium;Georgia;Bulgaria;Netherlands;Germany;Japan | ||
| 112 | NCT04113915 (ClinicalTrials.gov) | November 2019 | 1/10/2019 | Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy | Viral Hepatitis B and C Infection in Patients With Idiopathic Thrombocytopenic Purpura Treated With Triple Therapy | ITP - Immune Thrombocytopenic Purpura;Viral Hepatitis | Drug: triple therapy;Drug: Steroids | Safaa AA Khaled | NULL | Not yet recruiting | 18 Years | 75 Years | All | 150 | NULL | |
| 113 | JPRN-jRCTs041190069 | 01/10/2019 | 25/09/2019 | Clinical study to evaluate the efficacy of dexamethasone Palmitate for idiopathic (immune) thrombocytopenic purpura: ITP. | Clinical Investigation to evaluate the efficacy of dexamethasone palmitate for idiopathic (immune) thrombocytopenic purpura: ITP. - Clinical investigation of Dexamethasone Palmitate for ITP | Chronic Idiopathic Thrombocytopenic Purpura refractory, immune, thrombocytopenia,;D016553 | Administration of dexamethasone palmitate (5mg/day for 4 days) | Nakayama Takayuki | NULL | Recruiting | >= 20age old | <= 75age old | Both | 7 | Phase 1 | Japan |
| 114 | NCT03998982 (ClinicalTrials.gov) | June 25, 2019 | 25/6/2019 | Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP | A Single-center Prospective Randomized Study of Glycyrrhetinic Acid Combined With Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Drug: Glycyrrhetinic Acid;Drug: Dexamethasone | Shandong University | NULL | Recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | China |
| 115 | EUCTR2019-000361-21-GB (EUCTR) | 30/04/2019 | 06/02/2020 | A Multicenter, Open-Label, Phase 2 Trial to Evaluate the Safety and Activity of Efgartigimod (ARGX-113) in Adult Patients with Primary Immune Thrombocytopenia - ARGX-113-1804 | A Multicenter, Open-Label, Phase 2 Trial to Evaluate the Safety and Activity of Efgartigimod (ARGX-113) in Adult Patients with Primary Immune Thrombocytopenia - ARGX-113-1804 | Primary Immune Thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: efgartigimod Product Code: ARGX-113 Other descriptive name: ARGX-113 Product Name: efgartigimod Product Code: ARGX-113 Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | Hungary;Spain;Ukraine;United Kingdom | ||
| 116 | NCT03771378 (ClinicalTrials.gov) | January 16, 2019 | 7/12/2018 | Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) | Efficacy and Safety of rhTPO and Eltrombopag in the Treatment of Chinese Adults With Primary Immune Thrombocytopenia (ITP):a Multicenter, Double-blind, Randomized, Controlled Trial | Primary Immune Thrombocytopenia | Drug: rhTPO;Drug: eltrombopag | Wuhan Union Hospital, China | The First Affiliated Hospital of Nanchang University;The Third Xiangya Hospital of Central South University;The First People's Hospital of Yuhang District;Xiangyang Central Hospital | Recruiting | 18 Years | 75 Years | All | 96 | Phase 4 | China |
| 117 | NCT03252457 (ClinicalTrials.gov) | September 1, 2018 | 14/8/2017 | Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP | A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Purpura, Thrombocytopenic, Idiopathic;Immune Thrombocytopenia | Drug: Decitabine;Drug: Dexamethasone | Shandong University | Second Affiliated Hospital of Medical College Shandong University;Shandong Provincial Hospital;Qingdao Central Hospital;Chinese Academy of Medical Sciences | Not yet recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | China |
| 118 | NCT03412188 (ClinicalTrials.gov) | August 1, 2018 | 20/1/2018 | The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP. | Evaluation of the Effect of Eltrombopag on the Expression of Platelet Collagen Receptor Glycoprotein VI (GPVI) in Pediatric Patients With Chronic and Persistent Immune Thrombocytopenia. | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: conventional | Nayera Hazaa Elsherif | NULL | Completed | 1 Year | 18 Years | All | 36 | N/A | Egypt |
| 119 | NCT03830749 (ClinicalTrials.gov) | July 1, 2018 | 1/2/2019 | Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura | A Pilot Study to Evaluate the Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone as First Line Therapy for Subjects With Idiopathic Thrombocytopenic Purpura (ITP) | Immune Thrombocytopenia | Drug: Eltrombopag | Humanity & Health Medical Group Limited | NULL | Suspended | 18 Years | N/A | All | 60 | Phase 2 | Hong Kong |
| 120 | ChiCTR1800016177 | 2018-07-01 | 2018-05-17 | Withdraw by the investigator Efficacy and safety of danazol combined with low-dose glucocorticoids in the treatment of refractory/recurrent primary immune thrombocytopenia: a multicenter, single arm, prospective and open clinical study | Efficacy and safety of danazol combined with low-dose glucocorticoids in the treatment of refractory/recurrent primary immune thrombocytopenia: a multicenter, single arm, prospective and open clinical study prospective and open clinical study | Immune thrombocytopenic purpura | experimental group:danazol combined with low-dose glucocorticoids ; | Second Affiliated Hospital of Dalian Medical University | NULL | Temporary halt | 40 | 90 | Female | experimental group:30; | N/A | China |
| 121 | EUCTR2015-003653-17-CZ (EUCTR) | 07/05/2018 | 09/09/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Czech Republic;Spain;Bulgaria;Germany | ||
| 122 | NCT03443570 (ClinicalTrials.gov) | March 1, 2018 | 18/2/2018 | Rituximab Combining Bortezomib Versus Rituximab in Management of ITP | A Multicenter Prospective Randomized Study of Rituximab Combined With Bortezomib Versus Rituximab in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia;Purpura, Thrombocytopenic, Idiopathic | Drug: Rituximab;Drug: Bortezomib | Shandong University | The Affiliated Hospital of Qingdao University;Yantai Yuhuangding Hospital | Not yet recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | China |
| 123 | ChiCTR-OON-17014165 | 2018-01-01 | 2017-12-27 | A clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopenia | A clinical trial to evaluate the efficacy and safety of corticosteroids combined with cyclosporin A in the treatment of primary immune thrombocytopenia | Immune Thrombocytopenia | one:Corticosteroids;two:Corticosteroids combined with Cyclosporin A ; | Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology | NULL | Recruiting | 18 | 65 | Both | one:100;two:100; | China | |
| 124 | NCT03201848 (ClinicalTrials.gov) | November 16, 2017 | 27/6/2017 | The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia | A Multisite, Randomized, Double-Blind, Placebo-Controlled, and Parallel Study to Evaluate the Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia (Qi Yin Deficiency) | Immune Thrombocytopenia | Drug: Placebo;Drug: Huaiqihuang Granule | Qidong Gaitianli Medicines Co., Ltd | Huazhong University of Science and Technology | Recruiting | 1 Year | 14 Years | All | 216 | Phase 4 | China |
| 125 | ChiCTR-ONC-17012126 | 2017-09-01 | 2017-07-25 | A multicenter, prospective, one-arm clinical study of Sirolimus treats refractory and recurrence primary immune thrombocytopenia | A multicenter, prospective, one-arm clinical study of Sirolimus treats refractory and recurrence primary immune thrombocytopenia | refractory or recurrence primary immune thrombocytopenia | Case series:Sirolimus treats refractory or recurrence primary immune thrombocytopenia; | Department of Hematology, Xiniao Hospital | NULL | Pending | 18 | 80 | Both | Case series:103; | China | |
| 126 | EUCTR2015-003984-12-BG (EUCTR) | 15/08/2017 | 02/06/2017 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 127 | NCT03275740 (ClinicalTrials.gov) | July 17, 2017 | 6/7/2017 | A First in HumanTrial to Evaluate The Safety, Tolerability, And Pharmacokinetics Of PF-06755347 | A PHASE 1, RANDOMIZED, DOUBLE-BLIND, SPONSOR-OPEN, PLACEBO -CONTROLLED, FIRST-IN-HUMAN TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF PF 06755347 AFTER SINGLE ASCENDING INTRAVENOUS AND SUBCUTANEOUS DOSING IN HEALTHY ADULT MALE PARTICIPANTS AND OPEN-LABEL AFTER SINGLE SUBCUTANEOUS DOSING IN MALE AND FEMALE PARTICIPANTS WITH PERSISTENT OR CHRONIC PRIMARY IMMUNE THROMBOCYTOPENIA | Healthy;Primary Immune Thrombocytopenia;Polyradiculoneuropathy, Chronic Inflammatory Demyelinating | Drug: PF-06755347 intravenous healthy participant;Drug: Placebo intravenous healthy participant;Drug: PF-06755347 subcutaneous healthy participant;Drug: Placebo subcutaneous healthy participant;Drug: PF-06755347 subcutaneous ITP | Pfizer | NULL | Recruiting | 18 Years | 55 Years | All | 67 | Phase 1 | United States;Belgium;New Zealand;United Kingdom |
| 128 | EUCTR2015-003984-12-LT (EUCTR) | 14/07/2017 | 02/05/2017 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 19.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 129 | NCT03222843 (ClinicalTrials.gov) | June 30, 2017 | 18/7/2017 | Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient | A Phase III,Multicentre, Randomized, Double-Blind and Open-Label Study to Evaluate the Safety and Efficacy of Hetrombopag Olamine in Patients With Idiopathic Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Drug: Hetrombopag Olamine;Drug: matching placebo | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | N/A | All | 414 | Phase 3 | China |
| 130 | ChiCTR-ONC-17013230 | 2017-05-20 | 2017-11-03 | A single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopenia | A single center, one-arm, and open clinical study of PKA agonist (aminophylline) with conventional treatment for chronic or refractory primary immune thrombocytopenia | primary immune thrombocytopenia | Case series:PKA agonist (aminophylline) treats chronic or refractory primary immune thrombocytopenia; | Department of Hematology, The First Affiliated Hospital of Soochow University | NULL | Completed | 11 | 65 | Both | Case series:60; | China | |
| 131 | EUCTR2016-003038-26-DE (EUCTR) | 27/04/2017 | 08/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | ||
| 132 | NCT03102593 (ClinicalTrials.gov) | March 13, 2017 | 14/3/2017 | A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia | Drug: ARGX-113;Other: Placebo | argenx | Quintiles, Inc. | Completed | 18 Years | 85 Years | All | 38 | Phase 2 | Austria;Belgium;Czechia;France;Germany;Hungary;Poland;Spain;Ukraine;United Kingdom;Czech Republic |
| 133 | EUCTR2016-003038-26-CZ (EUCTR) | 10/02/2017 | 02/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia, followed by an Open-Label Treatment Period | Primary Immune Thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | ||
| 134 | EUCTR2016-003038-26-GB (EUCTR) | 08/02/2017 | 16/11/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia, followed by an Open-Label Treatment Period - ARGX-113-1603_Argenx BVBA | Primary Immune Thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Spain;Poland;Belgium;Ukraine;Austria;Germany;United Kingdom | ||
| 135 | EUCTR2016-003038-26-ES (EUCTR) | 07/02/2017 | 27/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia MedDRA version: 19.0;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | ||
| 136 | EUCTR2016-003038-26-AT (EUCTR) | 06/02/2017 | 14/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | ||
| 137 | EUCTR2015-003653-17-BG (EUCTR) | 27/01/2017 | 21/11/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Spain;Bulgaria;Germany;Czech Republic | ||
| 138 | EUCTR2015-003653-17-DE (EUCTR) | 27/01/2017 | 17/06/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 139 | EUCTR2016-003038-26-BE (EUCTR) | 27/01/2017 | 08/12/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia followed by an Open-Label Treatment Period. | Primary Immune Thrombocytopenia MedDRA version: 20.1;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Poland;Spain;Belgium;Ukraine;Austria;Germany;United Kingdom | ||
| 140 | EUCTR2016-003038-26-HU (EUCTR) | 19/01/2017 | 30/11/2016 | A Study of the safety and effectiveness of ARGX-113 in Patients with Primary Immune Thrombocytopenia | A Randomized, Double-blind, Placebo-controlled, Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia | Primary Immune Thrombocytopenia MedDRA version: 19.0;Level: LLT;Classification code 10074678;Term: Primary immune thrombocytopenic purpura;System Organ Class: 100000004851 ;Therapeutic area: Body processes [G] - Immune system processes [G12] | Product Name: ARGX-113 Product Code: ARGX-113 INN or Proposed INN: N/A Other descriptive name: ARGX-113 | Argenx BVBA | NULL | Not Recruiting | Female: yes Male: yes | 36 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Czech Republic;Hungary;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | ||
| 141 | EUCTR2015-005276-14-DK (EUCTR) | 08/12/2016 | 19/10/2016 | Maintenance treatment With rituximab in ITP | Prolonging the response by low-dose Rituximab maintenance therapy in immune thrombocytopenia: a randomized placebo-controlled trial- the PROLONG trial. - PROLONG-trial | Immune thrombocytopenia MedDRA version: 23.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Mabthera Product Name: rituximab Trade Name: Dexamethasone Abcur Product Name: Dexamethasone | Sykehuset Østfold HF | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;Egypt;Denmark;Norway;Tunisia | ||
| 142 | NCT04089267 (ClinicalTrials.gov) | December 2016 | 10/9/2019 | Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP) | Multicenter, Randomized, Open, Parallel Controlled Trials Evaluating the Efficacy and Safety of Different Human Thrombopoietin (rhTPO) Regimens in the Treatment of Patients With Primary Immune Thrombocytopenia (ITP) | ITP | Drug: TPO | Shenyang Sunshine Pharmaceutical Co., LTD. | NULL | Completed | 18 Years | N/A | All | 288 | Phase 4 | China |
| 143 | NCT02859909 (ClinicalTrials.gov) | November 2016 | 25/7/2016 | This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP) | An Open Label, Prospective, Randomized, Multicenter Study Investigating Clinical Efficacy and Safety of the Human Normal Immunoglobulin for Intravenous Administration BT595 in Patients With Chronic Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Biological: BT595 | Biotest | Syneos Health | Completed | 18 Years | 75 Years | All | 34 | Phase 3 | Bulgaria;Czechia;Germany;Hungary;Serbia;Spain |
| 144 | NCT02967328 (ClinicalTrials.gov) | November 2016 | 16/11/2016 | RP% Measurement by FCM as a Diagnostic Test for ITP | A Multi-Center Prospective Blind Study of RP% Measurement by Flow Cytometry in the Diagnosis of Primary Immune Thrombocytopenia | Immune Thrombocytopenia | Other: RP% Measurement by FCM as a Diagnostic Test for ITP | Shandong University | Jinan Central Hospital;Shandong Qianfoshan Hospital | Recruiting | 18 Years | 75 Years | Both | 500 | N/A | China |
| 145 | NCT03164915 (ClinicalTrials.gov) | October 24, 2016 | 22/5/2017 | A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) | A Multicenter, Open-Label, Phase III Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Biological: LIV-GAMMA SN Inj. | SK Plasma Co., Ltd. | NULL | Completed | 19 Years | N/A | All | 37 | Phase 3 | Korea, Republic of |
| 146 | ChiCTR-INR-16009363 | 2016-10-13 | 2016-10-10 | 'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia | 'Yu Xue Qi Huo' theory based integrated Traditional Chinese and Western Medicine in the diagnosis and treatment of stratified relapsed and refractory primary immune thrombocytopenia | Immune Thrombocytopenia | Study Group A:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously;Study Group A:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration;Control group B:Traditional Chinese Medicine for control group;Control group B:Cyclosporin A capsules: 5mg/kg/d p.o., adjusted according to the serum CsA concentration ;Study Group C:Yangyin Traditional Chinese Medicine: brew the TCM granules in warm water, 1 pack bid p.o. 1 hour after meal for 6 months continuously ;Study Group C:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L;Control Group D:Traditional Chinese Medicine for control group;Control Group D:rhTPO: 1ug/kg/d qd for 14 days continuously, ih, until platelet count reaches 100×10^9/L ; | Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine | NULL | Recruiting | 18 | 75 | Both | Study Group A:55;Study Group A:55;Control group B:55;Control group B:55;Study Group C:45;Study Group C:45;Control Group D:45;Control Group D:45; | China | |
| 147 | NCT02914054 (ClinicalTrials.gov) | October 1, 2016 | 19/9/2016 | Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With Dexamethasone | Therapy of Adults Affected by Idiopathic Thrombocytopenic Purpura With 3 Cycles Pulses of High-dose Dexamethasone (HD-DXM) | ITP;Croticosteroid Therapy | Drug: High dose Dexamethasone pulses;Drug: Prednisone | Isfahan University of Medical Sciences | Adibvira | Completed | 18 Years | N/A | All | 36 | Phase 2/Phase 3 | Iran, Islamic Republic of |
| 148 | EUCTR2015-003653-17-HU (EUCTR) | 07/09/2016 | 19/07/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 149 | EUCTR2015-003653-17-ES (EUCTR) | 06/09/2016 | 11/08/2016 | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | An open label, prospective, randomized, multicenter study investigating clinical efficacy and safety of the human normal immunoglobulin for intravenous administration BT595 in patients with chronic primary immune thrombocytopenia (ITP) | Chronic primary immune thrombocytopenia (ITP) MedDRA version: 19.0;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: IgG Next Generation Product Code: BT595 INN or Proposed INN: Human Normal Immunoglobulin (iv) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) | Biotest AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Hungary;Spain;Bulgaria;Germany | ||
| 150 | ChiCTR-IIR-16008994 | 2016-09-01 | 2016-08-08 | Safety and efficacy analysis of two conventional dosage regimens Methylprednisone for initial treatment of primary immune thrombocytopenia:A multicenter randomized controlled clinical trial | Safety and efficacy analysis of two conventional dosage regimens Methylprednisone for initial treatment of primary immune thrombocytopenia:A multicenter randomized controlled clinical trial | Primary immune thrombocytopenia | the short-course group (Group A):Oral methylprednisolone for 2 weeks, the initial dosage is 0.8mg/kg/d, than reduces to 0.4mg/kg/d for 1 week, than to 0.2mg/kg/d for 1 week, than stop.;the long-course treatment group (Group B):Oral methylprednisolone for 1 month, the initial dosage is 0.8mg/kg/d,than reduces to 0.4mg/kg/d for 1 month, than to 0.1mg/kg/d for 2 week, than stop.; | Institute of Hematology & Blood Diseases Hospital Chinese Academy of Medical Sciences & Peking Union Medical College | NULL | Pending | 18 | 60 | Both | the short-course group (Group A):150;the long-course treatment group (Group B):150; | 4 (Phase 4 study) | China |
| 151 | EUCTR2015-003984-12-PL (EUCTR) | 09/06/2016 | 06/04/2016 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 132 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Poland;Belgium;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 152 | EUCTR2015-003984-12-IT (EUCTR) | 11/04/2016 | 05/11/2020 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA - - | Primary immune thrombocytopenia (ITP) MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: [UCB7665 ] INN or Proposed INN: UCB7665 | UCB Biopharma SRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Phase 2 | Czechia;Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 153 | NCT02760251 (ClinicalTrials.gov) | April 2016 | 15/4/2016 | Immunomodulation With Romiplostim in Young Adults With ITP | Thrombopoietin-receptor Agonist-immunomodulation in Young Adult Primary Immune Thrombocytopenia (ITP): A Multi-center Open Label Trial With Romiplostim | Immune Thrombocytopenia | Drug: romiplostim | University Hospital, Basel, Switzerland | University Children's Hospital Basel | Completed | 18 Years | 45 Years | All | 15 | Phase 4 | Switzerland |
| 154 | NCT02298075 (ClinicalTrials.gov) | April 2016 | 17/11/2014 | Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia | Response Rate and Response Duration After Discontinuation of Treatment With Thrombopoietin Receptor Agonists in Patients Affected by Primary Immune Thrombocytopenia (pITP): Retrospective Study | Immune Thrombocytopenia | Drug: Eltrombopag;Drug: Romiplostin | Gruppo Italiano Malattie EMatologiche dell'Adulto | NULL | Unknown status | 18 Years | N/A | All | 100 | Italy | |
| 155 | EUCTR2015-003984-12-CZ (EUCTR) | 16/03/2016 | 22/12/2015 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 156 | NCT02718716 (ClinicalTrials.gov) | March 2016 | 11/3/2016 | Study to Evaluate Safety, Tolerability and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia | A Multicenter, Open-label, Multiple-dose Study to Evaluate the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Primary Immune Thrombocytopenia | Thrombocytopenia | Drug: UCB7665 | UCB Biopharma S.P.R.L. | Parexel | Completed | 18 Years | N/A | All | 66 | Phase 2 | Australia;Bulgaria;Czechia;Georgia;Germany;Italy;Moldova, Republic of;Poland;Romania;Spain;United Kingdom;Belgium;Czech Republic;Lithuania |
| 157 | EUCTR2015-003984-12-ES (EUCTR) | 29/02/2016 | 13/01/2016 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | Primary immune thrombocytopenia (ITP) MedDRA version: 18.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Moldova, Republic of | ||
| 158 | NCT02402998 (ClinicalTrials.gov) | February 24, 2016 | 22/3/2015 | Eltrombopag in Second Line Adult Primary Immune Thrombosytopenia | Eltrombopag as Second Line Therapy in Adult Patients With Primary Immune Thrombocytopenia (ESTIT Study) in an Attempt to Achieve Long-term Remission: a Single Arm Multicenter Phase II Clinical and Biological Study | Primacy Immune Thrombocytopenia | Drug: Eltrombopag | Gruppo Italiano Malattie EMatologiche dell'Adulto | NULL | Completed | 18 Years | N/A | All | 55 | Phase 2 | Italy |
| 159 | EUCTR2015-003984-12-BE (EUCTR) | 22/02/2016 | 15/01/2016 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 19.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 160 | EUCTR2015-003984-12-DE (EUCTR) | 05/02/2016 | 23/11/2015 | A study to test the safety of UCB7665 in patients with low levels of platelets. | A MULTICENTER, OPEN-LABEL, MULTIPLE-DOSE STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF UCB7665 IN SUBJECTS WITH PRIMARY IMMUNE THROMBOCYTOPENIA | MedDRA version: 20.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: UCB7665 Product Code: UCB7665 INN or Proposed INN: UCB7665 Other descriptive name: UCB7665 | UCB Biopharma SPRL | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Lithuania;United Kingdom;Italy;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Georgia;Germany;Moldova, Republic of | ||
| 161 | EUCTR2014-001429-33-PL (EUCTR) | 07/12/2015 | 09/10/2015 | Study to evaluate safety and efficacy in adult subjects with ITP | Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacyof BMS-986004 in Adult Subjects with Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia MedDRA version: 19.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anti-CD40LdAb Product Code: BMS-986004 INN or Proposed INN: N/A Other descriptive name: anti-CD40L | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Canada;Poland;Australia;Russian Federation;Georgia;Moldova, Republic of | ||
| 162 | NCT01609452 (ClinicalTrials.gov) | December 2015 | 23/5/2012 | MONICA-SC: A Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With ITP | MONICA-SC: A Randomized, Double-Blind, Placebo-Controlled Phase 2/3 Study to Evaluate the Efficacy, Safety and Tolerability of Blisibimod (A-623) Administration in Subjects With Immune Thrombocytopenic Purpura (ITP) | Immune Thrombocytopenic Purpura;Idiopathic Thrombocytopenic Purpura | Biological: Blisibimod;Other: Placebo | Anthera Pharmaceuticals | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 2/Phase 3 | NULL |
| 163 | NCT02642380 (ClinicalTrials.gov) | November 2015 | 24/12/2015 | Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP) | Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial | Immune Thrombocytopenia | Drug: Dexamethasone (4 cycles);Drug: Dexamethasone (1 cycle) | Shandong University | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 4 | China |
| 164 | NCT03219723 (ClinicalTrials.gov) | September 1, 2015 | 9/7/2017 | Drug Use Surveillance of Takecab for Supplement to Helicobacter Pylori Eradication | Drug Use Surveillance of Takecab Tablets Supplement to Helicobacter Pylori Eradication | Gastric/Duodenal Ulcer, Gastric MALT Lymphoma, Idiopathic Thrombocytopenic Purpura, or H. Pylori Gastritis, and Other | Drug: Vonoprazan;Drug: Amoxicillin hydrate;Drug: Clarithromycin;Drug: Metronidazole | Takeda | NULL | Completed | N/A | N/A | All | 560 | Japan | |
| 165 | JPRN-JapicCTI-153003 | 01/9/2015 | Drug use surveillance of Takecab for Supplement to Helicobacter pylori eradication | Drug use surveillance of Takecab tablets Supplement to Helicobacter pylori eradication | The following diseases in patients for whom H. pylori will be eradicated with triple therapy: Gastric ulcer, duodenal ulcer, gastric mucosa-associated lymphoid tissue (MALT) lymphoma, idiopathic thrombocytopenic purpura, stomach following endoscopic treatment of early gastric cancer, or H. pylori gastritis | Intervention name : Takecab tablets + amoxicillin + clarithromycin (first-line eradication) Takecab tablets + amoxicillin + metronidazole (second-line eradication) Dosage And administration of the intervention : For adults, the following three-drug regimen will be administered orally at the same time twice daily for 7 days: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 200 mg (potency) dose of clarithromycin. The dose of clarithromycin may be increased as clinically warranted. However, dosage should not exceed 400 mg (potency)/dose twice daily. If H. pylori eradication with a three-drug regimen comprising vonoprazan or proton pump inhibitor + amoxicillin hydrate + clarithromycin has been unsuccessful, as an alternative treatment, the following three drugs will be administered orally twice daily for 7 days to adults: 20 mg dose of vonoprazan, 750 mg (potency) dose of amoxicillin hydrate, and 250 mg dose of metronidazole. Participants will receive interventions as part of routine medical care. Control intervention name : null | TAKEDA PHARMACEUTICAL COMPANY LTD. | NULL | BOTH | 500 | NA | NULL | ||||
| 166 | NCT02868099 (ClinicalTrials.gov) | September 2015 | 11/8/2016 | Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP) | A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Drug: Romiplostim;Drug: Placebo | Kyowa Hakko Kirin China Pharmaceutical Co.,LTD. | NULL | Completed | 18 Years | N/A | All | 203 | Phase 3 | China |
| 167 | NCT02556814 (ClinicalTrials.gov) | September 2015 | 21/9/2015 | Caffeic Acid Combining High-dose Dexamethasone in Management of ITP | A Prospective, Multicenter, Placebo Controlled Study on Caffeic Acid Tablet Combining High-dose Dexamethasone in Management of Adult Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Drug: Caffeic acid tablets;Drug: Dexamethasone;Drug: placebo | Shandong University | NULL | Completed | 18 Years | 75 Years | All | 214 | Phase 4 | China |
| 168 | NCT02614846 (ClinicalTrials.gov) | August 2015 | 19/11/2015 | Safety and Efficacy Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients | A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura | Chronic Idiopathic Thrombocytopenic Purpura | Drug: Hetrombopag Olamine | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | Both | 29 | Phase 1 | China |
| 169 | EUCTR2015-001327-23-IT (EUCTR) | 26/06/2015 | 29/04/2015 | Study about the effect of a drug (Eltrombopag)which is administered in patients with thrombocytopenia primary Immune, a relative decrease of platelets in blood (small blood components that help the clotting process by sticking to the lining of blood vessels). | Eltrombopag as Second line Therapy in adult patients with primary Immune Thrombocytopenia (ESTIT study) in an attempt to achieve long-term remission: a single arm multicenter phase II clinical and biological study | Primary Immune Thrombocytopenia MedDRA version: 18.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Revolade INN or Proposed INN: NA Other descriptive name: ELTROMBOPAG OLAMINE Trade Name: Revolade Product Name: Revolade INN or Proposed INN: NA Other descriptive name: ELTROMBOPAG OLAMINE | Fondazione G.I.M.EM.A. Gruppo Italiano Malattie Ematologiche dell'Adulto | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | Italy | ||
| 170 | ChiCTR1900021211 | 2015-04-01 | 2019-02-01 | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | immune thrombocytopenia (ITP) | 1:eltrombopag 25-75mg daily for 3 months plus pulsed dexamethasone, 40mg daily for 4 days repeated every 4 weeks for 1-3 courses; | University Hospital, Macau | NULL | Recruiting | 18 | 100 | Both | 1:60; | China | |
| 171 | EUCTR2014-001429-33-GB (EUCTR) | 24/11/2014 | 07/10/2014 | Study to evaluate safety and efficacy in adult subjects with ITP | Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects with Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia MedDRA version: 19.0;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 100000004851 ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Anti-CD40LdAb Product Code: BMS-986004 INN or Proposed INN: N/A Other descriptive name: anti-CD40L | Bristol-Myers Squibb International Corporation | NULL | Not Recruiting | Female: yes Male: yes | 80 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Poland;United Kingdom | ||
| 172 | NCT02273960 (ClinicalTrials.gov) | November 17, 2014 | 3/10/2014 | Study to Evaluate Safety and Efficacy in Adult Subjects With ITP | Open Label, Adaptive Design, Ascending, Multiple-Dose Study to Evaluate Safety and Efficacy of BMS-986004 in Adult Subjects With Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenic Purpura | Drug: BMS-986004 75 mg IV;Drug: BMS-986004 225 mg IV;Drug: BMS-986004 675 mg IV;Drug: BMS-986004 1500 mg IV | Bristol-Myers Squibb | NULL | Completed | 18 Years | N/A | All | 46 | Phase 1/Phase 2 | United States;Australia;Canada;Georgia;Moldova, Republic of;Poland;Russian Federation;United Kingdom |
| 173 | EUCTR2013-001371-20-NL (EUCTR) | 06/05/2014 | 19/03/2014 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 174 | NCT02139501 (ClinicalTrials.gov) | May 2014 | 13/5/2014 | An Investigation of rhTPO With Different Frequencies in the Management of ITP | A Randomized Study to Evaluate the Efficacy and Safety of Different Doses and Frequencies of Recombinant Human Thrombopoietin (rhTPO) in the Management of Primary Immune Thrombocytopenia (ITP) | Immune Thrombocytopenia | Drug: Recombinant Human Thrombopoietin (rhTPO) | Shandong University | The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital | Completed | 18 Years | 60 Years | Both | 48 | Phase 3 | China |
| 175 | EUCTR2013-001371-20-PL (EUCTR) | 11/04/2014 | 24/02/2014 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 176 | NCT02403440 (ClinicalTrials.gov) | April 2014 | 20/3/2015 | A Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura (ITP) Patients | A Safety, Pharmacokinetics and Pharmacodynamics Study of Hetrombopag Olamine in Chronic Idiopathic Thrombocytopenic Purpura | Purpura, Thrombocytopenic, Idiopathic | Drug: Hetrombopag Olamine | Jiangsu HengRui Medicine Co., Ltd. | NULL | Recruiting | 18 Years | 65 Years | Both | 24 | Phase 1 | China |
| 177 | NCT01988506 (ClinicalTrials.gov) | January 6, 2014 | 7/11/2013 | Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases | Induction of Regulatory t Cells by Low Dose IL2 in Autoimmune and Inflammatory Diseases: a Transnosographic Approach | Rheumatoid Arthritis;Ankylosing Spondylitis;Systemic Lupus Erythematosus;Psoriasis;Behcet's Disease;Wegener's Granulomatosis;Takayasu's Disease;Crohn's Disease;Ulcerative Colitis;Autoimmune Hepatitis;Sclerosing Cholangitis;Gougerot-sjögren;Idiopathic Thrombocytopenic Purpura;Systemic Sclerosis | Drug: Interleukin 2 | Assistance Publique - Hôpitaux de Paris | Iltoo Pharma | Completed | 18 Years | N/A | All | 81 | Phase 2 | France |
| 178 | EUCTR2013-001371-20-GR (EUCTR) | 10/12/2013 | 11/11/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Tunisia;Netherlands;Germany;China;Korea, Republic of | |||
| 179 | EUCTR2013-000961-36-IT (EUCTR) | 22/11/2013 | 21/08/2013 | See the full title | Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed | Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP);Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ig VENA 100 ml vial Product Name: Ig VENA | Kedrion SpA | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Italy | ||
| 180 | EUCTR2013-000961-36-DE (EUCTR) | 15/11/2013 | 05/08/2013 | See the full title | Tolerability and safety evaluation of the administration of Ig VENA at high infusion rates. Open label phase III study. - Ig VENA Infusion Speed | Patients affected by primary or secondary immunodeficiency (ID) or patients affected by Primary Immune Thrombocytopenia (ITP) MedDRA version: 16.1;Level: PT;Classification code 10054979;Term: Secondary immunodeficiency;System Organ Class: 10021428 - Immune system disorders MedDRA version: 16.1;Classification code 10064859;Term: Primary immunodeficiency syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.1;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Ig VENA 50 g/l solution for infusion 100 ml vial + infusion set | Kedrion SpA | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Germany;Italy | ||
| 181 | EUCTR2013-001371-20-ES (EUCTR) | 15/10/2013 | 08/08/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of | ||
| 182 | EUCTR2013-001371-20-BE (EUCTR) | 15/10/2013 | 10/09/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 17.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 17.0;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 183 | EUCTR2013-001371-20-IE (EUCTR) | 06/09/2013 | 11/07/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 14.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of | ||
| 184 | EUCTR2010-019987-35-FR (EUCTR) | 26/06/2013 | 09/09/2010 | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITPRemission Rates in Adult Subjects with Immune Thrombocytopenia Purpura ReceivingRomiplostim | Adult immune thrombocytopenic purpura (ITP) MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 185 | EUCTR2009-014589-24-FR (EUCTR) | 12/06/2013 | 27/09/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 186 | NCT01882127 (ClinicalTrials.gov) | February 2013 | 19/4/2013 | All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Clinical Study on All-Trans Retinoic Acid (ATRA) Combining High-dose Dexamethasone Versus High-dose Dexamethasone Alone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: All-Trans Retinoid Acid(ATRA);Drug: Dexamethasone | Shandong University | NULL | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 3 | China |
| 187 | EUCTR2011-000830-12-GR (EUCTR) | 16/11/2012 | 08/10/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 15.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 15.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 3 | Hong Kong;Slovakia;Greece;Ukraine;Czech Republic;Poland;Belgium;Singapore;Romania;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China | ||
| 188 | EUCTR2011-001354-29-ES (EUCTR) | 24/09/2012 | 19/07/2012 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;Belarus;Hungary;Poland;Spain;Ukraine;Russian Federation;Germany;Italy | ||
| 189 | EUCTR2011-000830-12-NL (EUCTR) | 28/08/2012 | 23/08/2011 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | Czech Republic;Slovakia;Greece;Belgium;Poland;Ukraine;Singapore;Australia;Bulgaria;South Africa;Netherlands;New Zealand | ||
| 190 | EUCTR2012-000796-16-PL (EUCTR) | 17/08/2012 | 25/06/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 191 | EUCTR2011-000831-10-DE (EUCTR) | 18/07/2012 | 16/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 192 | EUCTR2012-000796-16-BG (EUCTR) | 18/07/2012 | 22/05/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria | ||
| 193 | EUCTR2011-000831-10-BE (EUCTR) | 16/07/2012 | 15/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 194 | EUCTR2012-000796-16-DE (EUCTR) | 09/07/2012 | 20/03/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human normal immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Germany;Czech Republic;Poland;Bulgaria | ||
| 195 | EUCTR2011-000831-10-GB (EUCTR) | 02/07/2012 | 28/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 196 | NCT01734057 (ClinicalTrials.gov) | July 2012 | 21/11/2012 | Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: recombinant human thrombopoietin (rhTPO); rituximab;Drug: Dexamethasone | Shandong University | The Affiliated Hospital of the Chinese Academy of Military Medical Sciences;Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;China Medical University, China;Zhejiang Provincial Hospital of TCM | Withdrawn | 18 Years | 75 Years | Both | 0 | Phase 3 | China |
| 197 | NCT01734044 (ClinicalTrials.gov) | July 2012 | 21/11/2012 | rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP | A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: recombinant human thrombopoietin (rhTPO); dexamethasone;Drug: Dexamethasone | Shandong University | The Affiliated Hospital of the Chinese Academy of Military Medical Sciences;Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;China Medical University, China;Zhejiang Provincial Hospital of TCM | Completed | 18 Years | 75 Years | Both | 158 | Phase 3 | China |
| 198 | EUCTR2011-000831-10-AT (EUCTR) | 05/06/2012 | 16/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 199 | EUCTR2012-000796-16-CZ (EUCTR) | 29/05/2012 | 04/04/2012 | Study to evaluate the efficacy and safety of human immuneglobulin in patients with primary immune thrombocytopenia | PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Octagam 10% Product Name: Octagam 10% INN or Proposed INN: Human Normal Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | OCTAPHARMA AG | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Czech Republic;Poland;Bulgaria;Germany | ||
| 200 | EUCTR2011-000831-10-ES (EUCTR) | 25/05/2012 | 29/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 201 | EUCTR2011-000831-10-NL (EUCTR) | 24/05/2012 | 24/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 202 | EUCTR2011-002184-17-DE (EUCTR) | 04/05/2012 | 13/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | |||
| 203 | EUCTR2011-002184-17-PL (EUCTR) | 17/04/2012 | 08/03/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | |||
| 204 | NCT01433978 (ClinicalTrials.gov) | March 26, 2012 | 13/9/2011 | A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: Avatrombopag;Drug: Standard of care | Eisai Inc. | NULL | Terminated | 18 Years | 99 Years | All | 24 | Phase 3 | United States |
| 205 | EUCTR2011-002184-17-IT (EUCTR) | 07/03/2012 | 08/03/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP).PETIT2: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT2 | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;Argentina;Poland;Germany | |||
| 206 | EUCTR2011-002184-17-GB (EUCTR) | 02/03/2012 | 17/01/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: E | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 207 | NCT01520909 (ClinicalTrials.gov) | March 2012 | 21/12/2011 | Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. | A Two Part, Double-blind, Randomized, Placebo-controlled and Open-label Study to Investigate the Efficacy, Safety and Tolerability of Eltrombopag, a Thrombopoietin Receptor Agonist, in Pediatric Patients With Previously Treated Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITP | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 1 Year | 17 Years | All | 92 | Phase 3 | United States;Argentina;Czech Republic;Germany;Hong Kong;Israel;Italy;Poland;Russian Federation;Spain;Taiwan;Thailand;United Kingdom;Chile |
| 208 | EUCTR2011-002184-17-ES (EUCTR) | 23/02/2012 | 21/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | Pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | Glaxosmithkline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 209 | EUCTR2011-002184-17-CZ (EUCTR) | 08/02/2012 | 08/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 210 | EUCTR2011-000830-12-CZ (EUCTR) | 19/01/2012 | 03/11/2011 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | Czech Republic;Slovakia;Greece;Poland;Belgium;Ukraine;Singapore;Australia;South Africa;Bulgaria;Netherlands;New Zealand | ||
| 211 | EUCTR2011-000830-12-PL (EUCTR) | 16/01/2012 | 17/11/2011 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | Slovakia;Greece;Ukraine;Austria;Czech Republic;Poland;Belgium;Singapore;Romania;South Africa;Bulgaria;Netherlands;New Zealand | ||
| 212 | EUCTR2009-014589-24-BG (EUCTR) | 04/01/2012 | 13/09/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 16.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Russian Federation;Bulgaria;Germany;India | ||
| 213 | NCT01444417 (ClinicalTrials.gov) | January 2012 | 29/9/2011 | Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients | A Phase 3 Randomized, Double Blind, Placebo Controlled Study to Determine the Safety and Efficacy of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP) | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic Purpura;Immune Thrombocytopenia | Drug: Romiplostim;Drug: Placebo | Amgen | NULL | Completed | 1 Year | 17 Years | All | 62 | Phase 3 | United States;Australia;Canada |
| 214 | NCT01549054 (ClinicalTrials.gov) | January 2012 | 31/1/2012 | A Study in Healthy Subjects to Evaluate Bioavailability of 4 Formulations of E5501 | A Single-center, Randomized, Open-label, Two-part Study to Evaluate Bioavailability of Prototype Third-generation Formulations of E5501 Relative to Second-generation Tablet Formulation in Healthy Subjects | Idiopathic Thrombocytopenic Purpura | Drug: 10-mg dose of E5501 2G tablet;Drug: 10-mg dose of E5501 cyclodextrin oral solution;Drug: 10-mg dose of E5501-P21% powder;Drug: 10-mg dose of E5501 lipid-based oral | Eisai Inc. | NULL | Completed | 18 Years | 55 Years | Both | 28 | Phase 1 | United Kingdom |
| 215 | EUCTR2011-000830-12-BE (EUCTR) | 30/12/2011 | 20/09/2011 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 3 | Hungary;Czech Republic;Belgium;Poland;Portugal;Hong Kong;Slovakia;Greece;Ukraine;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China | ||
| 216 | EUCTR2011-000830-12-BG (EUCTR) | 21/12/2011 | 12/12/2011 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 3 | Portugal;Hong Kong;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;South Africa;Netherlands;New Zealand;China | ||
| 217 | EUCTR2011-000263-27-BG (EUCTR) | 14/11/2011 | 25/08/2011 | An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells). | An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP | Chronic immune thrombocytopenic purpura (ITP) MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Privigen® Product Name: Privigen® INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring GmbH | NULL | Not Recruiting | Female: yes Male: yes | 150 | Serbia;Poland;Turkey;Bulgaria | |||
| 218 | EUCTR2011-001354-29-HU (EUCTR) | 09/11/2011 | 12/10/2011 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 219 | EUCTR2011-001354-29-IT (EUCTR) | 09/11/2011 | 07/03/2012 | An efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteriaadopting the new consensus terminology proposed by an internationalworking group (Rodeghiero et al, 2009) MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: human normal immunoglobulin for intravenous use Product Code: I10E INN or Proposed INN: NA Other descriptive name: NA | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Ukraine;Russian Federation;Germany;Italy | |||
| 220 | JPRN-JMA-IIA00070 | 31/10/2011 | 12/08/2011 | R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia | R-ITP: Clinical Evaluation of Rituximab in Primary Immune Thrombocytopenia | Idiopathic Thrombocytopenic Purpura | Intervention type:DRUG. Intervention1:rituximab, Dose form:INJECTION, Route of administration:INTRAVENOUS DRIP. | Keio University School of Medicine , Yoshitaka miyakawa | NULL | Completed | >=20 YEARS | No Limit | BOTH | 24 | Phase 3 | Japan |
| 221 | EUCTR2011-001354-29-DE (EUCTR) | 12/10/2011 | 06/10/2011 | An open-label, multicentre efficacy and safety study of a human immunoglobulin (project code I10E) in patients with primary Immune ThrombocytoPenia (ITP) | An open-label, multicentre efficacy and safety study of I10E in patients with primary Immune ThrombocytoPenia (ITP) | ITP diagnosis being defined by ASH-2011 and BCSH 2010 criteria adopting the new consensus terminology proposed by an international working group (Rodeghiero et al, 2009) MedDRA version: 15.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRVENOUS USE Product Code: I10E INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Other descriptive name: human Immunoglobulin | LFB BIOTECHNOLOGIES | NULL | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | |||
| 222 | NCT01349790 (ClinicalTrials.gov) | October 2011 | 5/5/2011 | Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NewGam) in Primary Immune Thrombocytopenia | Primary Thrombocytopenia | Drug: NewGam | Octapharma | NULL | Completed | 18 Years | 65 Years | All | 40 | Phase 3 | Germany |
| 223 | EUCTR2011-000830-12-SK (EUCTR) | 28/09/2011 | 26/08/2011 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag (proposed) Other descriptive name: AKR-501, YM-477 | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 84 | Phase 3 | Portugal;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China | ||
| 224 | EUCTR2009-014589-24-DE (EUCTR) | 22/09/2011 | 12/04/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: Immunglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 225 | EUCTR2009-014589-24-CZ (EUCTR) | 02/09/2011 | 26/04/2011 | NA | Prospective, Open-label, Non-controlled, Multicenter, Phase III Clinical Study to Evaluate the Efficacy and Safety of Immunoglobulin Intravenous (Human) 10% (NEWGAM) in Primary Immune Thrombocytopenia - NGAM-02 | Primary Immune Thrombocytopenia (ITP) MedDRA version: 15.0;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: NewGAM Product Code: NewGAM INN or Proposed INN: immunoglobulin Other descriptive name: IMMUNOGLOBULIN G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | ||
| 226 | NCT01437384 (ClinicalTrials.gov) | September 2011 | 19/9/2011 | Pharmacokinetic and Pharmacodynamic Study in Healthy Subjects Comparing the Interactions Between E5501 and Verapamil and Cyclosporine. | An Open-label, Single-sequence, Four-treatment Period Study to Evaluate Pharmacokinetic and Pharmacodynamic Interactions Between E5501 and Verapamil, and E5501 and Cyclosporine, Known P-glycoprotein Inhibitors in Healthy Subjects | Idiopathic Thrombocytopenic Purpura (ITP) | Drug: E5501 | Eisai Inc. | NULL | Completed | 18 Years | 55 Years | Both | 36 | Phase 1 | United States |
| 227 | EUCTR2011-000263-27-PL (EUCTR) | 22/07/2011 | 08/06/2011 | An non-blinded, mulicenter study to investigate the mechanisms which are involved in the interaction of red blood cells with the study drug IgPro10 in patients with chronic immune thrombocytopenic purpura (ITP) who have shown signs of hemolysis (a breakdown or destruction of red blood cells). | An open-label, prospective, multicenter study to investigate the specificity of in vivo antibody binding to red blood cells in subjects with chronic immune thrombocytopenic purpura (ITP) treated with IgPro10 (Privigen®) who have shown signs of hemolysis. - Privigen® in ITP | Chronic immune thrombocytopenic purpura (ITP) MedDRA version: 15.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Privigen® Product Name: Privigen® INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | CSL Behring LLC | NULL | Not Recruiting | Female: yes Male: yes | 150 | Serbia;Poland;Turkey;Bulgaria | |||
| 228 | NCT01525836 (ClinicalTrials.gov) | May 2011 | 31/1/2012 | rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP | Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP. | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: rituximab; recombinant human thrombopoietin (rhTPO);Drug: Rituximab | Shandong University | The Affiliated Hospital of the Chinese Academy of Military Medical Sciences;The First Affiliated Hospital of Anhui Medical University;The First Affiliated Hospital of Dalian Medical University;Shandong Provincial Hospital;Shenzhen Second People's Hospital;First Hospital of China Medical University | Completed | 18 Years | 72 Years | Both | 123 | Phase 3 | China |
| 229 | EUCTR2006-002946-13-NL (EUCTR) | 19/04/2011 | 15/12/2010 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | France;Spain;Netherlands;United Kingdom | |||
| 230 | NCT01327872 (ClinicalTrials.gov) | February 2011 | 30/3/2011 | Subject Variability in Two Lots of E5501 Administered to Fed and Fasted Healthy Subjects | A Randomized, Open-Label, 4-Group, 2-Period Replicate Design Study to Evaluate Within- and Between-Subject Variability in Exposure of Two Lots of E5501 20 mg Tablets, Administered as Single Doses of 40 mg, in the Fasted and Fed Conditions to Healthy Subjects | Purpura, Thrombocytopenic, Idiopathic;Acute Idiopathic Thrombocytopenic Purpura;Chronic Thrombocytopenia | Drug: E5501 40 mg 2 x 20-mg tablets, orally, fasted;Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food;Drug: E5501 40mg 2 x 20-mg tablets, orally, fasted;Drug: E5501 40 mg 2 x 20-mg tablets, orally, with food | Eisai Inc. | NULL | Completed | 18 Years | 55 Years | Both | 84 | Phase 1 | Netherlands |
| 231 | NCT01805648 (ClinicalTrials.gov) | February 2011 | 22/2/2013 | Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP | A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia | Thrombocytopenia;Immune Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Drug: rhTPO | Peking Union Medical College | Shenyang Sunshine Pharmaceutical Co., LTD. | Recruiting | 14 Years | 70 Years | Both | 120 | Phase 3 | China |
| 232 | NCT01416311 (ClinicalTrials.gov) | December 21, 2010 | 9/6/2011 | Drug Use Investigation for REVOLADE (ITP) | Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura) | Purpura, Thrombocytopaenic, Idiopathic | Drug: Eltrombopag | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 5797 | NULL | |
| 233 | EUCTR2010-019987-35-CZ (EUCTR) | 21/12/2010 | 26/11/2010 | Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Adult immune thrombocytopenic purpura (ITP) MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 234 | NCT01143038 (ClinicalTrials.gov) | November 30, 2010 | 10/6/2010 | Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim | A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim | Idiopathic Thrombocytopenic Purpura | Biological: Romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 75 | Phase 2 | United States;Australia;Czechia;France;Germany;Italy;Poland;Spain;United Kingdom;Czech Republic |
| 235 | EUCTR2010-019987-35-GB (EUCTR) | 29/10/2010 | 26/08/2010 | Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Adult immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Spain;Germany;Italy;United Kingdom | ||
| 236 | EUCTR2010-019987-35-DE (EUCTR) | 21/10/2010 | 25/08/2010 | Interventional Study in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim | A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Adult immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Nplate Product Name: romiplostim Product Code: AMG 531 INN or Proposed INN: romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;United States;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 237 | EUCTR2008-004347-10-BG (EUCTR) | 14/10/2010 | 12/05/2010 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 238 | EUCTR2010-019987-35-ES (EUCTR) | 22/09/2010 | 31/08/2010 | Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Estudio de fase 2, intervencionista, de un solo brazo para describir la respuesta plaquetaria y las tasas de remisión de PTI en sujetos adultos con Púrpura Trombocitopénica Inmune que reciben Romiplostim.-------------------------------------------------------A Phase 2, Interventional, Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects with Immune Thrombocytopenia Purpura Receiving Romiplostim | Púrpura Trombocitopénica Inmune(Idiopática) (PTI) en adultos----------------------------------Adult immune thrombocytopenic purpura (ITP) MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: NPLATE 500 microgramos polvo para solución inyectable INN or Proposed INN: ROMIPLOSTIM Other descriptive name: ROMIPLOSTIM | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 2 | France;Czech Republic;Spain;Germany;United Kingdom;Italy | ||
| 239 | NCT01356511 (ClinicalTrials.gov) | September 2010 | 17/5/2011 | High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) | High-dose Dexamethasone and Conventional Dose Prednisone, for the First-line Treatment of Adults With ITP: a Multicenter, Randomized Controlled, Clinical Trial | Purpura, Thrombocytopenic, Idiopathic | Drug: Prednisone;Drug: Dexamethasone | Shandong University | Chinese Academy of Medical Sciences;Peking Union Medical College Hospital;Ruijin Hospital;Wuhan Union Hospital, China;Tongji Hospital;Shandong University of Traditional Chinese Medicine;Anhui Provincial Hospital;Zhejiang Provincial Hospital of TCM;Second Hospital of Shanxi Medical University;Xinjiang Uygur Autonomous Region People's Hospital;Shenzhen Second People's Hospital | Completed | 18 Years | 80 Years | Both | 261 | Phase 4 | China |
| 240 | EUCTR2009-010421-39-FR (EUCTR) | 25/05/2010 | 09/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;Hungary;Czech Republic;Germany;Italy | ||
| 241 | EUCTR2009-010421-39-CZ (EUCTR) | 06/05/2010 | 03/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Hungary;Czech Republic;Germany;Italy | |||
| 242 | EUCTR2009-010421-39-HU (EUCTR) | 05/05/2010 | 10/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Czech Republic;Hungary;Germany;Italy | |||
| 243 | EUCTR2009-010421-39-DE (EUCTR) | 10/03/2010 | 04/02/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Hungary;Czech Republic;Germany;Italy | |||
| 244 | EUCTR2009-014842-28-PL (EUCTR) | 21/01/2010 | 02/10/2009 | A study to assess the safety and effectiveness of the study drug(SM101) versus placebo( dummy treatment)in adult patients with chronic Primary Immune Thrombocytopenia(ITP) | A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Primary Immune Thrombocytopenia (ITP). | Primary Immune Thrombocytopenia MedDRA version: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SM101 20mg/mL Product Code: SM101 INN or Proposed INN: SM101 Product Name: SM101 5mg/mL Product Code: SM101 INN or Proposed INN: SM101 | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 1 | Belgium;Poland;Ukraine;Russian Federation;Germany | ||
| 245 | EUCTR2009-014842-28-DE (EUCTR) | 14/01/2010 | 21/09/2009 | A study to assess the safety and effectiveness of the study drug (SM101) versus a placebo (dummy treatment) in adult patients with chronic Primary Immune Thrombocytopenia (ITP). | A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Primary Immune Thrombocytopenia (ITP). | Primary Immune Thrombocytopenia MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: SM101 20mg/mL Product Code: SM101 INN or Proposed INN: SM101 Product Name: SM101 5mg/mL Product Code: SM101 INN or Proposed INN: SM101 | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 69 | Phase 1 | Belgium;Poland;Ukraine;Russian Federation;Germany | ||
| 246 | EUCTR2009-014842-28-BE (EUCTR) | 06/01/2010 | 14/09/2009 | A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Idiopathic Thrombocytopenic Purpura (ITP). | A Randomised, Multi-centre, Double-Blind, Placebo-Controlled, Single/Multiple Dose Escalation Phase Ib/IIa Clinical Trial to Investigate the Safety and Efficacy of Recombinant Human Soluble Fc-gamma Receptor IIb (SM101) for Intravenous Application in the Treatment of Patients with Chronic Adult Idiopathic Thrombocytopenic Purpura (ITP). | Idiopathic Thrombocytopenic Purpura MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: SM101 Product Code: SM101 | SuppreMol GmbH | NULL | Not Recruiting | Female: yes Male: yes | 51 | Phase 1;Phase 2 | Poland;Belgium;Germany | ||
| 247 | NCT03258866 (ClinicalTrials.gov) | January 1, 2010 | 18/8/2017 | The Study of Different Dose Rituximab in the Treatment of ITP | The Clinical Randomized Controlled Study of Different Dose Rituximab in the Treatment of Primary Immune Thrombocytopenia | Purpura, Thrombocytopenic, Idiopathic;Immune Thrombocytopenia | Drug: Rituximab | Shandong University | NULL | Completed | 10 Years | 70 Years | All | 62 | Phase 4 | China |
| 248 | NCT01071954 (ClinicalTrials.gov) | December 30, 2009 | 17/12/2009 | A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura | An Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP | Biological: Romiplostim | Amgen | NULL | Completed | 1 Year | N/A | All | 66 | Phase 3 | United States;Australia;Canada;Spain |
| 249 | EUCTR2008-004347-10-SI (EUCTR) | 12/11/2009 | 06/10/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 250 | EUCTR2008-004347-10-IT (EUCTR) | 07/10/2009 | 16/09/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP. | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP. | Thrombocytopenia associated with ITP MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: NPLATE INN or Proposed INN: ROMIPLOSTIM | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 251 | NCT00908037 (ClinicalTrials.gov) | September 30, 2009 | 21/5/2009 | Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) | A Three Part, Staggered Cohort, Open-label and Double Blind, Randomized, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients With Chronic ITP. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 1 Year | 17 Years | All | 82 | Phase 2 | United States;Canada;France;Netherlands;Spain;United Kingdom |
| 252 | EUCTR2006-002946-13-GB (EUCTR) | 18/09/2009 | 06/07/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Netherlands;United Kingdom | ||
| 253 | EUCTR2006-002946-13-FR (EUCTR) | 18/09/2009 | 05/08/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;Spain;Netherlands;United Kingdom | ||
| 254 | EUCTR2008-004347-10-SE (EUCTR) | 09/09/2009 | 24/06/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 255 | NCT00907478 (ClinicalTrials.gov) | August 11, 2009 | 21/5/2009 | Study on Bone Marrow Morphology in Adults Receiving Romiplostim for Treatment of Thrombocytopenia Associated With Immune Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in Bone Marrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment of Thrombocytopenia Associated With Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Biological: romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 169 | Phase 4 | Australia;Austria;Belgium;Canada;Czech Republic;Estonia;Germany;Hungary;Italy;Lithuania;Mexico;Poland;Romania;Russian Federation;Slovenia;Spain;Sweden;United States |
| 256 | EUCTR2006-002946-13-ES (EUCTR) | 30/07/2009 | 06/07/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT | Chronic Idiopathic Thrombocytopenic PurpuraPúrpura Trombocitopénica Idiopática Crónica MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline S.A. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | France;Spain;Netherlands;United Kingdom | ||
| 257 | EUCTR2008-004347-10-ES (EUCTR) | 16/07/2009 | 05/06/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)? | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP).-----------------------------------------------------?Estudio prospectivo, fase IV, multicéntrico y abierto para evaluar los cambios en la morfología de la médula ósea en sujetos adultos que reciben romiplostim para el tratamiento de la trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI)? | Thrombocytopenia associated with ITP.---------------------------trombocitopenia asociada a púrpura trombocitopénica inmune (idiopática) (PTI) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 258 | EUCTR2008-004347-10-BE (EUCTR) | 10/07/2009 | 29/05/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Belgium;Poland;Bulgaria;Germany;Sweden | ||
| 259 | EUCTR2008-001597-33-NL (EUCTR) | 18/06/2009 | 29/05/2008 | Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITP | Development of chronic disease in newly diagnosed Idiopathic Thrombocytopenic Purpura of Childhood. A randomized controlled study on the influence of treatment with intravenous gammaglobulin on the course of the disease. - The TIKI study : Treatment with or without IVIG in Kids with acute ITP | Acute Idiopathic Thrombocytopenic Purpura (ITP) in children MedDRA version: 14.1;Level: LLT;Classification code 10023095;Term: ITP;System Organ Class: 10005329 - Blood and lymphatic system disorders | Trade Name: Nanogam Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | University Medical Center Utrecht | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Netherlands | ||
| 260 | EUCTR2008-004347-10-AT (EUCTR) | 17/06/2009 | 06/05/2009 | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | A Prospective, Phase IV, Open-Label, Multi-Center Study Evaluating Changes in BoneMarrow Morphology in Adult Subjects Receiving Romiplostim for the Treatment ofThrombocytopenia Associated with Immune (Idiopathic) Thrombocytopenia Purpura (ITP) | Thrombocytopenia associated with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | ||
| 261 | NCT01506414 (ClinicalTrials.gov) | June 2009 | 16/11/2011 | Recombinant Human Thrombopoietin in Combination With Rituximab in Immune Thrombocytopenia (ITP) | A Multicentre Investigation of Recombinant Human Thrombopoietin (Rh-TPO) Combine With Low-dose Rituximab in Management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP) | Purpura;Idiopathic Thrombocytopenic Purpura | Drug: rhTPO in combination with Rituximab | Ming Hou | Peking Union Medical College Hospital;Chinese Academy of Medical Sciences;First Affiliated Hospital, Sun Yat-Sen University;West China Hospital;Shandong Provincial Hospital;Wuhan Union Hospital, China;Zhejiang University | Completed | 16 Years | 75 Years | Both | 91 | Phase 3 | China |
| 262 | NCT00888901 (ClinicalTrials.gov) | May 2009 | 27/4/2009 | Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag | Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. | Idiopathic Thrombocytopenic Purpura | Drug: eltrombopag;Drug: corticosteroids (Aprednislon) | Ingrid Pabinger, MD | GlaxoSmithKline | Completed | 18 Years | 90 Years | Both | 30 | Phase 4 | Austria |
| 263 | EUCTR2008-005871-92-SE (EUCTR) | 05/02/2009 | 10/12/2008 | En fas 1 studie av effekt av Tysabri (natalizumab), en IgG4 humaniserad monoklonal antikropp specifik mot VLA-4 (integrin alfa-4), administrerad som infusion 1 gång/månad under 3 månader hos patienter med kronisk idiopatisk trombocytopen purpura (ITP). - Tysabri for ITP | En fas 1 studie av effekt av Tysabri (natalizumab), en IgG4 humaniserad monoklonal antikropp specifik mot VLA-4 (integrin alfa-4), administrerad som infusion 1 gång/månad under 3 månader hos patienter med kronisk idiopatisk trombocytopen purpura (ITP). - Tysabri for ITP | Chronic idiopathic thrombocytopenic purpura (ITP) MedDRA version: 9.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Trade Name: Tysabri Product Name: Tysabri | Sahlgrenska University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Sweden | ||||
| 264 | EUCTR2007-000638-37-IE (EUCTR) | 06/01/2009 | 10/04/2008 | An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of AMG 531 in Severely Refractory Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 265 | NCT00902018 (ClinicalTrials.gov) | January 2009 | 8/5/2009 | Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP) | The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) Pathway | Immune Thrombocytopenia | Drug: Eltrombopag;Drug: Romiplostim;Other: healthy controls | Weill Medical College of Cornell University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 266 | EUCTR2005-005918-20-FR (EUCTR) | 23/12/2008 | 23/10/2008 | Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study | Rituximab as second line treatment for ITP:A Multicentre, Randomized, Double blind, Placebo-controlled, Phase III study.The RITP study” - RITP study | Immune thrombocytopenic purpura (ITP) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Trade Name: MabThera Product Name: MabThera Other descriptive name: RITUXIMAB | Rikshospitalet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | United Kingdom;France;Sweden | ||
| 267 | EUCTR2007-000638-37-ES (EUCTR) | 17/12/2008 | 17/10/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).-------------------------------------------------------?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)? | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP).-------------------------------------------------------?Estudio Abierto de Romiplostim en Sujetos Adultos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) (PTI)? | Immune (Idiopathic) Thrombocytopenic Purpura.-------------------------------------------Púrpura Trombocitopénica Inmune (Idiopática) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Ireland;Spain;Italy;Austria | |||
| 268 | EUCTR2007-000638-37-SK (EUCTR) | 17/12/2008 | 27/10/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 2 | Czech Republic;Slovakia;Spain;Belgium;Ireland;Austria;Netherlands;Italy;United Kingdom | ||
| 269 | NCT00860600 (ClinicalTrials.gov) | September 2008 | 10/3/2009 | Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients | The Clinical Trial of PG2 in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura (ITP) | Drug: PG2 | PhytoHealth Corporation | NULL | Completed | 18 Years | N/A | All | 14 | Phase 2 | Taiwan |
| 270 | EUCTR2004-000172-13-GB (EUCTR) | 20/08/2008 | 11/02/2005 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Czech Republic;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 271 | EUCTR2007-000638-37-GB (EUCTR) | 18/08/2008 | 11/04/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | Czech Republic;United Kingdom;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 272 | EUCTR2006-000471-14-IE (EUCTR) | 02/08/2008 | 05/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 273 | NCT00749112 (ClinicalTrials.gov) | August 2008 | 8/9/2008 | Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias | Low Doses of Alemtuzumab and Rituximab in the Treatment of Refractory Autoimmune Cytopenias | Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune | Drug: Alemtuzumab, Rituximab | Hospital Universitario Dr. Jose E. Gonzalez | NULL | Completed | 16 Years | N/A | Both | 19 | Phase 2/Phase 3 | Mexico |
| 274 | EUCTR2004-000172-13-IT (EUCTR) | 22/07/2008 | 10/07/2008 | AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA | AN OPEN LABEL STUDY EVALUATING THE SAFETY AND EFFICACY OF LONG-TERM DOSING OF AMG 531 IN THROMBOCYTOPENIC SUBJECTS WITH IMMUNE (IDIOPATHIC) THROMBOCITOPENIC PURPURA | Thrombocytopenia in subjects with ITP MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: AMG531 Product Code: AMG531 INN or Proposed INN: AMG531 | AMGEN S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;Belgium;Austria;Germany;United Kingdom;Italy | |||
| 275 | EUCTR2008-000417-30-IT (EUCTR) | 19/06/2008 | 11/04/2008 | Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207 | Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP0207 - GIMEMA ITP0207 | ITP Primary Immune Thrombocytopenic Purpura in newly diagnosed untreated adult patients MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Dexamethasone INN or Proposed INN: Dexamethasone Product Name: Prednisone INN or Proposed INN: Prednisone | G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 276 | EUCTR2004-000172-13-CZ (EUCTR) | 11/06/2008 | 11/04/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Germany;United Kingdom;Czech Republic;Belgium;Italy;Austria | |||
| 277 | EUCTR2007-000638-37-IT (EUCTR) | 09/06/2008 | 04/08/2008 | An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209 | An open label study of AMG531 in severely refractory thrombocytopenic subjects with immune (idiopathic) Thrombocytopenic Purpura (ITP) - AMG 531 20040209 | Thrombocytopenia in subjects with ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG531 Product Code: AMG531 | AMGEN S.P.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 278 | EUCTR2004-000172-13-AT (EUCTR) | 13/05/2008 | 10/03/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria | |||
| 279 | EUCTR2004-000172-13-DE (EUCTR) | 07/05/2008 | 07/02/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;United Kingdom;Germany;Belgium;Italy;Austria | |||
| 280 | NCT00511147 (ClinicalTrials.gov) | May 2008 | 1/8/2007 | IGIV Study for Chronic ITP Patients Ages 3-70 | A Multi-center, Prospective, Open-label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients With Idiopathic (Immune) Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Biological: IGIV3I Grifols 10% | Grifols Biologicals Inc. | Instituto Grifols, S.A. | Completed | 3 Years | 70 Years | All | 64 | Phase 3 | United States;Canada;India;Puerto Rico |
| 281 | NCT00828750 (ClinicalTrials.gov) | May 2008 | 22/1/2009 | Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)- | Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, Idiopathic | Drug: Eltrombopag oral tablets | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 19 | Phase 3 | Japan |
| 282 | EUCTR2007-000638-37-AT (EUCTR) | 30/04/2008 | 04/03/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 283 | EUCTR2007-000638-37-CZ (EUCTR) | 09/04/2008 | 11/02/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 284 | EUCTR2004-000172-13-BE (EUCTR) | 08/04/2008 | 27/02/2008 | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura ( ITP) - Not available | Thrombocytopenia in subjects with Immune Thrombocytopenic Purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Code: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 350 | Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria | |||
| 285 | EUCTR2007-000638-37-BE (EUCTR) | 13/03/2008 | 27/02/2008 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 286 | EUCTR2007-000638-37-NL (EUCTR) | 28/02/2008 | 29/11/2007 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Immune (Idiopathic) Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Romiplostim Product Code: AMG 531 INN or Proposed INN: Romiplostim | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | |||
| 287 | NCT00571467 (ClinicalTrials.gov) | December 2007 | 10/12/2007 | Phase I Safety and Tolerability Study of Staphylococcal Protein A in Adult Patients With Chronic ITP | An Open Label, Sequential, Dose Escalation, Repeat-dose Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of PRTX-100 in Adult Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura (ITP) | Drug: PRTX-100 (Staphylococcal protein A) | Protalex, Inc. | NULL | Terminated | 18 Years | N/A | All | 9 | Phase 1 | Australia;New Zealand |
| 288 | EUCTR2006-000471-14-FI (EUCTR) | 30/11/2007 | 08/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 289 | EUCTR2006-000471-14-IT (EUCTR) | 16/11/2007 | 13/09/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | Idiopathic thrombocytopenic purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag | GLAXOSMITHKLINE R&D LTD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 290 | EUCTR2006-000471-14-AT (EUCTR) | 11/11/2007 | 23/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 291 | EUCTR2006-000471-14-DE (EUCTR) | 26/10/2007 | 30/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 292 | NCT00603642 (ClinicalTrials.gov) | October 1, 2007 | 17/1/2008 | P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Double Blind, Placebo Controlled Phase 3 Study Evaluating the Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Drug: Placebo;Drug: AMG 531 | Amgen | NULL | Completed | 20 Years | N/A | All | 34 | Phase 3 | Japan |
| 293 | EUCTR2006-000471-14-DK (EUCTR) | 01/10/2007 | 14/08/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 294 | EUCTR2006-000470-78-CZ (EUCTR) | 01/10/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 295 | EUCTR2007-003569-42-ES (EUCTR) | 29/09/2007 | 03/08/2007 | Estudio Aleatorizado, Doble Ciego, Controlado con Placebo, de Fase 1/2 para Determinar la Seguridad y la Eficacia de AMG 531 en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) Crónica | Estudio Aleatorizado, Doble Ciego, Controlado con Placebo, de Fase 1/2 para Determinar la Seguridad y la Eficacia de AMG 531 en Sujetos Pediátricos Trombocitopénicos con Púrpura Trombocitopénica Inmune (Idiopática) Crónica | Púrpura Trombocitopénica Inmune (Idiopática) (PTI) MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: proteína recombinante estimulante de la megacariopoyesis Product Code: AMG 531 | Amgen Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Spain | |||
| 296 | NCT00540423 (ClinicalTrials.gov) | September 2007 | 5/10/2007 | Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment- | Chronic Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, Idiopathic | Drug: SB-497115-GR 12.5mg;Drug: SB-497115-GR 25mg;Drug: SB-497115-GR 12.5mg matching placebo;Drug: SB-497115-GR 50 mg | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 23 | Phase 3 | Japan |
| 297 | NCT00504075 (ClinicalTrials.gov) | September 2007 | 18/7/2007 | A Study to Find How Safe and Effective GAMMAPLEX® is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura | Chronic Idiopathic Thrombocytopenic Purpura | Biological: Gammaplex, intravenous immunoglobulin | Bio Products Laboratory | NULL | Completed | 18 Years | 70 Years | All | 35 | Phase 3 | United States;Argentina;India |
| 298 | EUCTR2006-000471-14-CZ (EUCTR) | 16/08/2007 | 24/07/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 299 | NCT00515203 (ClinicalTrials.gov) | July 2007 | 9/8/2007 | Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects | A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Drug: Placebo;Drug: AMG 531 | Amgen | NULL | Completed | 1 Year | 17 Years | All | 22 | Phase 1/Phase 2 | Australia;Canada;Spain;United States |
| 300 | EUCTR2006-003700-18-PT (EUCTR) | 04/06/2007 | 06/02/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 301 | NCT00362349 (ClinicalTrials.gov) | June 2007 | 9/8/2006 | Ig NextGen 10% in Idiopathic Thrombocytopenic Purpura (ITP) Patients | A Single-arm, Open Label, Multi-centre Study Evaluating the Efficacy and Safety of Ig NexGen 10% in Patients With Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura (ITP) | Drug: IgNextGen 10% | CSL Limited | NULL | Completed | 18 Years | N/A | Both | 19 | Phase 3 | Australia |
| 302 | EUCTR2006-003700-18-CZ (EUCTR) | 25/05/2007 | 07/02/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy;Austria | |||
| 303 | EUCTR2005-003552-35-FR (EUCTR) | 10/05/2007 | 29/12/2006 | Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A | Clinical study to evaluate the efficacity and safety of octagam®10% in idiopathic thrombocytopenic purpura in adults - N/A | the medical condition which have to be investigated is the evolution of platelets counts in adults with a idiopathic thrombocytopenic purpura, with less than 20 10^9 platelets/L and treated by Octagam10% (immunoglobulines). | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Phase 3 | France;Czech Republic;Austria;Germany | ||
| 304 | EUCTR2006-003700-18-DE (EUCTR) | 08/05/2007 | 25/04/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria | |||
| 305 | NCT00475423 (ClinicalTrials.gov) | May 2007 | 17/5/2007 | A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura. | An Open Label Study of a Fixed Dose Regimen of MabThera on Overall Response Rate in Patients With Refractory, Relapsing or Chronic Idiopathic Thrombocytopenic Purpura. | Idiopathic Thrombocytopenic Purpura | Drug: rituximab [MabThera/Rituxan] | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 122 | Phase 2 | Australia |
| 306 | NCT00625443 (ClinicalTrials.gov) | May 2007 | 19/2/2008 | Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003 | A Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) Who Completed 28 Days of Study Treatment in Protocol 501-CL-003 | Idiopathic Thrombocytopenic Purpura | Drug: Blinded (placebo);Drug: Open Label (Avatrombopag tablets);Drug: Blinded (Avatrombopoag tablets) | Eisai Inc. | NULL | Completed | 18 Years | N/A | All | 53 | Phase 2 | United States |
| 307 | EUCTR2006-002943-10-ES (EUCTR) | 19/04/2007 | 21/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Spain;Germany;United Kingdom | ||
| 308 | EUCTR2006-002943-10-GB (EUCTR) | 13/04/2007 | 26/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom | ||
| 309 | EUCTR2006-000470-78-GR (EUCTR) | 27/03/2007 | 03/01/2007 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 310 | EUCTR2006-003700-18-BE (EUCTR) | 26/03/2007 | 21/03/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Austria;Netherlands;Germany;Italy;United Kingdom;Portugal;France;Czech Republic;Belgium | ||
| 311 | EUCTR2006-002943-10-DE (EUCTR) | 16/03/2007 | 28/03/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | United Kingdom;Germany;Spain | |||
| 312 | EUCTR2006-003700-18-GB (EUCTR) | 08/03/2007 | 01/01/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 313 | NCT00424177 (ClinicalTrials.gov) | March 2007 | 17/1/2007 | Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) | An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States |
| 314 | EUCTR2006-000471-14-GR (EUCTR) | 27/02/2007 | 04/09/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 315 | EUCTR2006-000470-78-DE (EUCTR) | 14/02/2007 | 05/12/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Czech Republic;Germany;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 316 | EUCTR2006-003700-18-AT (EUCTR) | 05/02/2007 | 21/12/2006 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 317 | NCT00441090 (ClinicalTrials.gov) | February 2007 | 27/2/2007 | Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | A Phase 2 Double-Blind, Randomized, Dose-Ranging, Placebo-Controlled, Parallel Group Study of AKR-501 Tablets Taken Orally Once Daily for 28 Days in Patients With Chronic Idiopathic Thrombocytopenic Purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, Idiopathic | Drug: Placebo;Drug: Avatrombopag tablets | Eisai Inc. | NULL | Completed | 18 Years | N/A | All | 64 | Phase 2 | United States |
| 318 | EUCTR2006-003700-18-FR (EUCTR) | 31/01/2007 | 11/01/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom | ||
| 319 | EUCTR2006-003700-18-NL (EUCTR) | 29/01/2007 | 12/09/2007 | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura | Immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: AMG 531 Product Code: AMG 531 INN or Proposed INN: AMG 531 | Amgen Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria | |||
| 320 | EUCTR2006-000471-14-SK (EUCTR) | 23/01/2007 | 30/11/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 17.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 321 | EUCTR2006-000470-78-IT (EUCTR) | 17/01/2007 | 05/02/2007 | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | Idiopathic thrombocytopenic purpura ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR Product Name: Eltrombopag Product Code: SB-497115-GR | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 322 | EUCTR2006-000470-78-SK (EUCTR) | 17/01/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 323 | EUCTR2006-000470-78-FR (EUCTR) | 22/12/2006 | 16/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 324 | EUCTR2006-000470-78-FI (EUCTR) | 12/12/2006 | 25/10/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 325 | NCT00415532 (ClinicalTrials.gov) | December 1, 2006 | 21/12/2006 | Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura | A Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic Purpura | Drug: Medical Standard of Care for ITP;Biological: Romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 234 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom;United States |
| 326 | NCT00392951 (ClinicalTrials.gov) | December 2006 | 24/10/2006 | Sirolimus for Autoimmune Disease of Blood Cells | Sirolimus for Patients With Chronic and/or Refractory Autoimmune Cytopenias: A Pilot Series | Autoimmune Pancytopenia;Autoimmune Lymphoproliferative Syndrome (ALPS);Evans Syndrome;Idiopathic Thrombocytopenic Purpura;Anemia, Hemolytic, Autoimmune;Autoimmune Neutropenia;Lupus Erythematosus, Systemic;Inflammatory Bowel Disease;Rheumatoid Arthritis | Drug: sirolimus | Children's Hospital of Philadelphia | NULL | Completed | 1 Year | 30 Years | All | 30 | Phase 1/Phase 2 | United States |
| 327 | EUCTR2006-000470-78-DK (EUCTR) | 29/11/2006 | 10/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 328 | EUCTR2006-000470-78-ES (EUCTR) | 22/11/2006 | 13/04/2012 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Russian Federation;Italy;Vietnam;India;France;Denmark;Peru;Netherlands;Tunisia;China;Finland;Austria;United Kingdom;Czech Republic;Canada;Brazil;Poland;Germany;New Zealand | ||
| 329 | EUCTR2006-000470-78-AT (EUCTR) | 22/11/2006 | 20/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 330 | EUCTR2006-000470-78-GB (EUCTR) | 22/11/2006 | 08/05/2008 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom | ||
| 331 | NCT00370331 (ClinicalTrials.gov) | November 2006 | 29/8/2006 | RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag | A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 197 | Phase 3 | United States;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;India;Italy;Netherlands;New Zealand;Peru;Poland;Russian Federation;Slovakia;Spain;Taiwan;Tunisia;Ukraine;United Kingdom;Vietnam;Estonia |
| 332 | EUCTR2006-000470-78-NL (EUCTR) | 30/10/2006 | 01/09/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 333 | EUCTR2006-000471-14-GB (EUCTR) | 23/10/2006 | 03/06/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune Thrombocytopenic Purpura (ITP) MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 334 | EUCTR2006-000471-14-NL (EUCTR) | 23/08/2006 | 21/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Germany;Sweden | |||
| 335 | EUCTR2006-000471-14-SE (EUCTR) | 14/08/2006 | 29/05/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 18.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 336 | EUCTR2006-000471-14-FR (EUCTR) | 16/06/2006 | 24/11/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 337 | EUCTR2006-000471-14-SI (EUCTR) | 13/06/2006 | 23/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece | |||
| 338 | NCT00426270 (ClinicalTrials.gov) | June 2006 | 22/1/2007 | Clinical Study to Evaluate the Efficacy and Safety of Octagam 10% in Idiopathic Thrombocytopenic Purpura in Adults | Clinical Study to Evaluate the Efficacy and Safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in Adults | Immune Thrombocytopenic Purpura | Drug: Octagam 10% | Octapharma | NULL | Completed | 18 Years | N/A | All | 116 | Phase 3 | Austria |
| 339 | NCT00351468 (ClinicalTrials.gov) | June 2006 | 10/7/2006 | EXTEND (Eltrombopag Extended Dosing Study) | EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag olamine (SB-497115-GR) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 302 | Phase 3 | United States;Australia;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Italy;Korea, Republic of;Netherlands;New Zealand;Pakistan;Peru;Poland;Romania;Russian Federation;Slovakia;Slovenia;Spain;Sweden;Taiwan;Thailand;Tunisia;Ukraine;United Kingdom;Vietnam;India;Ireland;Mexico;Norway |
| 340 | EUCTR2005-003552-35-DE (EUCTR) | 28/03/2006 | 13/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Czech Republic;Germany;France | |||
| 341 | EUCTR2005-003552-35-CZ (EUCTR) | 13/03/2006 | 23/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam(R) 10% in Idiopathic Thrombocytopenic Purpura in adults - NA | Clinical study to evaluate the efficacy and safety of Octagam(R) 10% in Idiopathic Thrombocytopenic Purpura in adults - NA | Idiopathic Thrombocytopenic Purpura in adults actively bleeding or at high risk of bleeding MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam 10% | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | Germany;Czech Republic;France | |||
| 342 | NCT00467571 (ClinicalTrials.gov) | March 2006 | 27/4/2007 | Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura | Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura | Chronic Idiopathic Thrombocytopenic Purpura;Helicobacter Pylori Infection | Drug: lansoprazole, clarithromycin, amoxycillin | Mahidol University | Ramathibodi Hospital | Completed | 2 Years | 18 Years | Both | 26 | Phase 4 | Thailand |
| 343 | EUCTR2005-003552-35-AT (EUCTR) | 20/02/2006 | 16/01/2006 | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Clinical study to evaluate the efficacy and safety of Octagam® 10% in Idiopathic Thrombocytopenic Purpura in adults. - N/A | Idiopathic thrombocytopenic purpura, in adults actively bleeding or at high risk bleeding. MedDRA version: 7.0;Level: LLT;Classification code 10021245 | Product Name: Octagam® 10% INN or Proposed INN: Human Immunoglobulin G | Octapharma AG | NULL | Not Recruiting | Female: yes Male: yes | 116 | France;Czech Republic;Austria;Germany | |||
| 344 | NCT00451594 (ClinicalTrials.gov) | September 2005 | 22/3/2007 | High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP | A Randomized Controlled Multicentre Trial of High Dose Dexamethasone Versus Conventional Dose Prednisolone for Adults With Untreated Idiopathic Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Drug: Dexamethasone;Drug: Prednisolone | Cooperative Study Group A for Hematology | NULL | Completed | 16 Years | N/A | Both | 157 | Phase 3 | Korea, Republic of |
| 345 | NCT00244257 (ClinicalTrials.gov) | August 2005 | 25/10/2005 | Safety Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP) | Phase I, Open-Label, Multi-center, Single-Dose, Dose-Escalating, Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamic Study of GMA161 in Patients With Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura | Biological: GMA161 | Genzyme, a Sanofi Company | NULL | Terminated | 18 Years | N/A | Both | 10 | Phase 1 | United States |
| 346 | NCT00770562 (ClinicalTrials.gov) | July 2005 | 9/10/2008 | A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP) | A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura | Idiopathic Thrombocytopenic Purpura | Drug: rituximab;Drug: Dexamethasone | Hoffmann-La Roche | NULL | Completed | 18 Years | N/A | All | 103 | Phase 3 | Italy |
| 347 | EUCTR2005-000859-15-IT (EUCTR) | 14/04/2005 | 20/06/2005 | Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults. | Randomized prospective study comparing dexamethasone and dexamethasone plus rituximab in the treatment of idiopathic thrombocytopenic purpura (ITP) in adults. | Front-line treatment of adult ITP MedDRA version: 6.1;Level: PT;Classification code 10021245 | Trade Name: Mabthera INN or Proposed INN: Rituximab Trade Name: Mabthera INN or Proposed INN: Rituximab | ROCHE | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 348 | NCT00102336 (ClinicalTrials.gov) | April 7, 2005 | 27/1/2005 | AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy | A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Prior to Splenectomy | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Biological: AMG 531;Drug: Placebo | Amgen | NULL | Completed | 18 Years | N/A | All | 62 | Phase 3 | United States |
| 349 | NCT00102323 (ClinicalTrials.gov) | March 29, 2005 | 27/1/2005 | AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy | A Randomized, Placebo Controlled Study Evaluating the Efficacy and Safety of AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Drug: Placebo;Biological: AMG 531 | Amgen | NULL | Completed | 18 Years | N/A | All | 63 | Phase 3 | France;Netherlands;Spain;United States |
| 350 | NCT00508820 (ClinicalTrials.gov) | February 1, 2005 | 26/7/2007 | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With ITP | An Open Label Study of Romiplostim in Adult Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenic Purpura | Biological: Romiplostim | Amgen | NULL | Completed | 18 Years | N/A | All | 407 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;Ireland;Italy;Netherlands;Poland;Slovakia;Spain;Switzerland;United Kingdom;United States |
| 351 | NCT00128882 (ClinicalTrials.gov) | November 2004 | 8/8/2005 | Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D | Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D | Idiopathic Thrombocytopenic Purpura | Drug: Anti-D | University of Aarhus | Kjaersgaard, Mimi, M.D. | Completed | 1 Year | 14 Years | Both | 45 | Phase 2 | Denmark |
| 352 | NCT01713855 (ClinicalTrials.gov) | October 2004 | 18/10/2012 | Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura | Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura;Immune Thrombocytopenic Purpura | Biological: Inactivated Trivalent Influenza vaccine | Neufeld, Ellis J, MD, PhD | Terrana ITP Research Fund | Completed | 18 Months | 18 Years | Both | 10 | N/A | United States |
| 353 | NCT00909077 (ClinicalTrials.gov) | August 2004 | 26/5/2009 | The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP) | A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura | Drug: Dexamethasone;Drug: Dexamethasone and Rituximab | Copenhagen University Hospital at Herlev | NULL | Completed | 18 Years | N/A | All | 155 | Phase 3 | Denmark |
| 354 | NCT00116688 (ClinicalTrials.gov) | August 2004 | 30/6/2005 | Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | An Open Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) | Thrombocytopenia;Idiopathic Thrombocytopenic Purpura | Biological: Romiplostim | Amgen | NULL | Completed | 1 Year | N/A | All | 313 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom;United States |
| 355 | NCT00161564 (ClinicalTrials.gov) | February 2004 | 8/9/2005 | A Trial to Treat Patients With ITP Who Do Not Achieve a Durable Response to Rituxan Alone | A Randomized Trial Comparing Higher Doses of Rituximab (Rituxan) With Standard Doses of Rituxan in Combination With CVP (Cyclophosphamide, Vincristine,and Prednisone) in Subjects With Chronic ITP Who Have Failed/Relapsed After Rituxan Treatment | Idiopathic Thrombocytopenic Purpura (ITP) | Drug: Rituximab | Weill Medical College of Cornell University | Genentech, Inc. | Withdrawn | 12 Years | N/A | All | 0 | Phase 2 | United States |
| 356 | NCT01713738 (ClinicalTrials.gov) | May 2003 | 18/10/2012 | Clinical Trial of Rituximab in Children and Adolescents With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Open Label, Phase I/II Trial of Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura (ITP)in Children and Adolescents | Idiopathic Thrombocytopenic Purpura (ITP);Immune Thrombocytopenic Purpura (ITP) | Drug: rituximab | Neufeld, Ellis J, MD, PhD | Genentech, Inc.;Biogen Idec;Glaser Pediatric Research Network;Terrana ITP Research Fund | Completed | 18 Months | 18 Years | Both | 36 | Phase 1/Phase 2 | United States |
| 357 | NCT00162006 (ClinicalTrials.gov) | January 13, 2003 | 8/9/2005 | Efficacy and Safety Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura | Prospective Open-Label Study of the Efficacy and Safety of Immune Globulin Intravenous (Human), 10% TVR Solution in Adult Subjects With Chronic Idiopathic Thrombocytopenic Purpura | Immune Thrombocytopenic Purpura (ITP) | Drug: Immune Globulin Intravenous (Human), 10% Triple Virally Reduced Solution | Baxalta now part of Shire | NULL | Completed | 18 Years | 65 Years | All | 28 | Phase 2 | Czechia;Germany;Hungary;Poland;Czech Republic |
| 358 | NCT00111475 (ClinicalTrials.gov) | July 1, 2002 | 20/5/2005 | Evaluating the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) | A Dose-finding Study Evaluating the Safety and Efficacy of AMG 531 in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP) | Idiopathic Thrombocytopenic Purpura | Drug: Romiplostim;Drug: Placebo | Amgen | NULL | Completed | 18 Years | 65 Years | All | 45 | Phase 2 | NULL |
| 359 | NCT00151840 (ClinicalTrials.gov) | October 2001 | 8/9/2005 | Efficacy and Safety of IVIG-L in ITP Patients | Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients | Purpura, Thrombocytopenic, Idiopathic | Drug: IVIG-L | Sanquin | NULL | Completed | 18 Years | N/A | Both | 20 | Phase 3 | Poland |
| 360 | NCT00107913 (ClinicalTrials.gov) | September 2001 | 11/4/2005 | Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura | Phase II Study of Doxil in the Treatment of Patients With Refractory Idiopathic Thrombocytopenic Purpura | Autoimmune Thrombocytopenic Purpura | Drug: Doxil | Hematology and Oncology Specialists | NULL | Recruiting | N/A | N/A | Both | 10 | Phase 2 | United States |
| 361 | EUCTR2006-002946-13-Outside-EU/EEA (EUCTR) | 24/02/2012 | A study of a new medication, eltrombopag, for the treatment of childhood chronic immune thrombocytopenic purpura (ITP), a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA | GlaxoSmithKline Research & Development Limited | NULL | NA | Female: yes Male: yes | 70 | Canada;United States | ||||
| 362 | EUCTR2020-004032-21-GR (EUCTR) | 19/04/2021 | A Phase 3 study to evaluate the efficacy and safety of efgartigimod PH 20 Subcutaneous in adult patients with primary immune thrombocytopenia. | A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and the Safety of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia - ADVANCE SC | Primary immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: efgartigimod PH20 SC INN or Proposed INN: efgartigimod alfa | argenx BV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 156 | Phase 3 | Portugal;Serbia;United States;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Jordan;Peru;Australia;Denmark;South Africa;Tunisia;China;Korea, Republic of;Turkey;United Kingdom;Mexico;Argentina;Poland;Romania;Georgia;Bulgaria;Norway;Germany;New Zealand;Japan | |||
| 363 | EUCTR2011-005586-21-Outside-EU/EEA (EUCTR) | 07/12/2011 | A research study to determine if an experimental IVIG product, Gammaplex®, is safe, tolerable, and effective when given to patients who have Idiopathic Thrombocytopenic Purpura | A Phase III, Multicenter, Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX® in Chronic Idiopathic Thrombocytopenic Purpura - n/a | Idiopathic thrombocytopenic purpura. MedDRA version: 14.0;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Gammaplex Product Name: Gammaplex Product Code: n/a INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN | Bio Products Laboratory Limited | NULL | NA | Female: yes Male: yes | 35 | Phase 3 | Argentina;India;United States |