63. 特発性血小板減少性紫斑病 [臨床試験数:127,薬物数:127(DrugBank:32),標的遺伝子数:40,標的パスウェイ数:112]
Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | NCT04113915 | November 2019 | 11 November 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 | Not recruiting | 18 Years | 75 Years | All | 150 | Phase 4 | ||
2 | NCT04132050 | October 31, 2019 | 28 October 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. | Recruiting | 20 Years | N/A | All | 24 | Phase 3 | Japan | |
3 | JPRN-jRCTs041190069 | 01/10/2019 | 7 October 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) | Takayuki Nakayama | Recruiting | >= 20age old | <= 75age old | Both | 7 | Phase 1 | none | |
4 | NCT03998982 | June 25, 2019 | 15 July 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 | Recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | China | |
5 | NCT03771378 | January 16, 2019 | 28 January 2019 | 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 |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | NCT03275740 | December 20, 2018 | 26 August 2019 | 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 INFUSIONS TO HEALTHY ADULT MALE PARTICIPANTS | Polyradiculoneuropathy, Chronic Inflammatory Demyelinating;Idiopathic Thrombocytopenic Purpura | Drug: PF-06755347;Drug: Placebo comparator | Pfizer | Recruiting | 18 Years | 40 Years | Male | 64 | Phase 1 | Belgium;United States | |
7 | NCT03252457 | September 1, 2018 | 27 August 2018 | 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 recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | China |
8 | NCT03412188 | August 1, 2018 | 27 August 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 | Recruiting | 1 Year | 18 Years | All | 40 | N/A | Egypt | |
9 | NCT03830749 | July 1, 2018 | 25 February 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 | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | Hong Kong | |
10 | NCT03692754 | June 1, 2018 | 9 October 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 | Shandong University | Recruiting | 18 Years | 80 Years | All | 30 | Phase 4 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
11 | EUCTR2015-003653-17-CZ | 07/05/2018 | 28 February 2019 | 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Normal Immunoglobulin (iv) Current Sponsor code: BT595 Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Biotest AG | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Hungary;Czech Republic;Spain;Bulgaria;Germany | |||
12 | NCT03443570 | March 1, 2018 | 26 February 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 recruiting | 18 Years | 75 Years | All | 200 | Phase 3 | China |
13 | ChiCTR-OON-17014165 | 2018-01-01 | 8 January 2018 | 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 | Recruiting | 18 | 65 | Both | one:100;two:100; | Other | China | |
14 | NCT03201848 | November 16, 2017 | 4 November 2019 | 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 |
15 | ChiCTR-ONC-17012126 | 2017-09-01 | 21 August 2017 | 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 | Not Recruiting | 18 | 80 | Both | Case series:103; | New Treatment Measure Clinical Study | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
16 | NCT03222843 | June 30, 2017 | 16 December 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. | Recruiting | 18 Years | N/A | All | 414 | Phase 3 | China | |
17 | ChiCTR-ONC-17013230 | 2017-05-20 | 6 November 2017 | 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 | Not Recruiting | 11 | 65 | Both | Case series:60; | New Treatment Measure Clinical Study | China | |
18 | NCT03102593 | March 13, 2017 | 20 May 2019 | 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 BVBA | Quintiles, Inc. | Not recruiting | 18 Years | 85 Years | All | 38 | Phase 2 | Austria;Belgium;Czechia;France;Germany;Hungary;Poland;Spain;Ukraine;United Kingdom;Czech Republic |
19 | EUCTR2016-003038-26-GB | 08/02/2017 | 7 January 2019 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: N/A CAS Number: 1821402-21-4 Current Sponsor code: ARGX-113 Other descriptive name: ARGX-113 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | Argenx BVBA | Authorised | Female: yes Male: yes | 36 | Phase 2 | France;Hungary;Czech Republic;Poland;Belgium;Spain;Ukraine;Austria;Germany;United Kingdom | |||
20 | EUCTR2015-003653-17-DE | 27/01/2017 | 30 April 2019 | 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Normal Immunoglobulin (iv) Current Sponsor code: BT595 Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Biotest AG | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
21 | EUCTR2015-005276-14-DK | 08/12/2016 | 20 February 2017 | 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: 19.0 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: RITUXIMAB CAS Number: 174722-31-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 500 mg/50 ml- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Dexamethasone Abcur Product Name: Dexamethasone Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4 mg/ tbl.- | Sykehuset Østfold HF | Authorised | Female: yes Male: yes | 100 | Phase 3 | France;United States;Denmark;Norway;Tunisia;United Kingdom | |||
22 | NCT02859909 | November 2016 | 26 August 2019 | 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 | Not recruiting | 18 Years | 75 Years | All | 34 | Phase 3 | Bulgaria;Czechia;Germany;Hungary;Serbia;Spain |
23 | ChiCTR-INR-16009363 | 2016-10-13 | 18 April 2017 | '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 | 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; | New Treatment Measure Clinical Study | China | |
24 | NCT02914054 | October 1, 2016 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 36 | Phase 2/Phase 3 | Iran, Islamic Republic of |
25 | NCT03164915 | September 27, 2016 | 11 June 2018 | 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. | Not recruiting | 19 Years | N/A | All | 37 | Phase 3 | Korea, Republic of | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
26 | EUCTR2015-003653-17-HU | 07/09/2016 | 28 February 2019 | 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Normal Immunoglobulin (iv) Current Sponsor code: BT595 Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Biotest AG | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany | |||
27 | EUCTR2015-003653-17-ES | 06/09/2016 | 28 February 2019 | 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Normal Immunoglobulin (iv) Current Sponsor code: BT595 Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | Biotest AG | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Czech Republic;Hungary;Spain;Bulgaria;Germany | |||
28 | ChiCTR-IIR-16008994 | 2016-09-01 | 18 April 2017 | 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 | Not Recruiting | 18 | 60 | Both | the short-course group (Group A):150;the long-course treatment group (Group B):150; | Phase 4 study | China | |
29 | NCT02298075 | April 2016 | 5 November 2018 | 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 | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | Italy | |
30 | NCT02760251 | April 2016 | 26 August 2019 | 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 | Not recruiting | 18 Years | 45 Years | All | 15 | Phase 4 | Switzerland |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
31 | NCT02718716 | March 2016 | 1 April 2019 | 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 | Not recruiting | 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 |
32 | EUCTR2015-003984-12-ES | 29/02/2016 | 28 February 2019 | 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: UCB7665 CAS Number: 1584645-37-3 Current Sponsor code: UCB7665 Other descriptive name: UCB7665 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | UCB Biopharma SPRL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Spain;Lithuania;United Kingdom;Italy;France;Czech Republic;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Moldova, Republic of | |||
33 | EUCTR2015-003984-12-BE | 22/02/2016 | 28 February 2019 | 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: UCB7665 CAS Number: 1584645-37-3 Current Sponsor code: UCB7665 Other descriptive name: UCB7665 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | UCB Biopharma SPRL | 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 | |||
34 | EUCTR2015-003984-12-DE | 05/02/2016 | 28 February 2019 | 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: UCB7665 CAS Number: 1584645-37-3 Current Sponsor code: UCB7665 Other descriptive name: UCB7665 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | UCB Biopharma SPRL | 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 | |||
35 | NCT01609452 | December 2015 | 10 August 2015 | 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 | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 2/Phase 3 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
36 | NCT02642380 | November 2015 | 2 May 2016 | 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 | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 4 | China | |
37 | JPRN-JapicCTI-153003 | 01/9/2015 | 2 April 2019 | 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. | BOTH | 500 | NA | |||||
38 | NCT03219723 | September 1, 2015 | 16 December 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 | Not recruiting | N/A | N/A | All | 500 | N/A | Japan | |
39 | NCT02556814 | September 2015 | 2 May 2016 | 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: placebo;Drug: Dexamethasone;Drug: Caffeic acid tablets | Shandong University | Recruiting | 18 Years | 75 Years | Both | 240 | Phase 4 | China | |
40 | NCT02868099 | September 2015 | 16 December 2017 | 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. | Not recruiting | 18 Years | N/A | All | 203 | Phase 3 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
41 | NCT02614846 | August 2015 | 7 December 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. | Recruiting | 18 Years | 65 Years | Both | 29 | Phase 1 | China | |
42 | NCT02402998 | June 2015 | 20 August 2018 | 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 | Not recruiting | 18 Years | N/A | All | 52 | Phase 2 | Italy | |
43 | ChiCTR1900021211 | 2015-04-01 | 4 February 2019 | 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 | Recruiting | 18 | 100 | Both | 1:60; | Pilot study | China | |
44 | NCT02273960 | November 17, 2014 | 29 July 2019 | 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 | Not recruiting | 18 Years | N/A | All | 46 | Phase 1/Phase 2 | United States;Australia;Canada;Georgia;Moldova, Republic of;Poland;Russian Federation;United Kingdom | |
45 | NCT02139501 | May 2014 | 2 May 2016 | 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 | Not recruiting | 18 Years | 60 Years | Both | 48 | Phase 3 | China |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
46 | NCT02403440 | April 2014 | 13 April 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. | Recruiting | 18 Years | 65 Years | Both | 24 | Phase 1 | China | |
47 | NCT01988506 | January 6, 2014 | 27 August 2018 | 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 | Recruiting | 18 Years | N/A | All | 132 | Phase 2 | France |
48 | EUCTR2013-000961-36-IT | 22/11/2013 | 16 November 2015 | 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 Pharmaceutical Form: Solution for infusion | Kedrion SpA | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Italy | |||
49 | EUCTR2013-000961-36-DE | 15/11/2013 | 3 April 2017 | 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 Level: PT Classification code 10064859 Term: Primary immunodeficiency syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders 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] - Immune System Diseases [C20] | Trade Name: Ig VENA 50 g/l solution for infusion 100 ml vial + infusion set | Kedrion SpA | Not Recruiting | Female: yes Male: yes | 35 | Phase 3 | Germany;Italy | |||
50 | EUCTR2013-001371-20-IE | 06/09/2013 | 16 August 2016 | 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 Continued Treatment 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB-497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB-497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB-497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Eltrombopag Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB-497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Product Name: Eltrombopag Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB-497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- | GlaxoSmithKline Research and Development Ltd | 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 | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
51 | NCT01882127 | February 2013 | 2 May 2016 | 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 | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 3 | China | |
52 | EUCTR2011-000830-12-NL | 28/08/2012 | 29 January 2018 | 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 System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.1 Level: LLT Classification code 10036735 Term: Primary thrombocytopenia System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 16.1 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Avatrombopag (proposed) CAS Number: 1254322-84-3 Current Sponsor code: E5501 Other descriptive name: AKR-501, YM-477 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: E5501 Product Code: E5501 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Avatrombopag (proposed) CAS Number: 1254322-84-3 Current Sponsor code: E5501 Other descriptive name: AKR-501, YM-477 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: E5501 Product Code: E5501 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Avatrombopag (proposed) CAS Number: 1254322-84-3 Current Sponsor code: E5501 Other descriptive name: AKR-501, YM-477 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Eisai Limited | Not Recruiting | Female: yes Male: yes | 49 | Phase 3 | Czech Republic;Slovakia;Greece;Belgium;Poland;Ukraine;Singapore;Australia;Bulgaria;South Africa;Netherlands;New Zealand | |||
53 | EUCTR2012-000796-16-DE | 09/07/2012 | 2 September 2013 | Study to evaluate the efficacy and safety of human immune globulin 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% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human normal immunoglobulin CAS Number: 308067-58-5 Current Sponsor code: Octagam 10% Other descriptive name: IMMUNOGLOBULIN G Concentration unit: % percent Concentration type: equal Concentration number: 10- | OCTAPHARMA AG | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | Germany;Czech Republic;Poland;Bulgaria | |||
54 | NCT01734044 | July 2012 | 2 May 2016 | 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 | Not recruiting | 18 Years | 75 Years | Both | 158 | Phase 3 | China |
55 | NCT01734057 | July 2012 | 2 May 2016 | 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 | Not recruiting | 18 Years | 75 Years | Both | 0 | Phase 3 | China |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
56 | NCT01433978 | April 2012 | 3 August 2015 | 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) | 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: E5501 - Avatrombopag maleate | Eisai Inc. | Not recruiting | 18 Years | N/A | Both | 23 | Phase 3 | United States | |
57 | EUCTR2011-002184-17-CZ | 08/02/2012 | 14 November 2016 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-62-3 Current Sponsor code: SB-497115 Other descriptive name: REVOLADE, PROMACTA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ELTROMBOPAG Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-62-3 Current Sponsor code: SB-497115 Other descriptive name: REVOLADE, PROMACTA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ELTROMBOPAG Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-62-3 Current Sponsor code: SB-497115 Other descriptive name: REVOLADE, PROMACTA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ELTROMBOPAG Product Code: SB-497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-62-3 Current Sponsor code: SB-497115 Other descriptive name: REVOLADE, PROMACTA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ELTROMBOPAG Product Code: SB-497115 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-62-3 Current Sponsor code: SB-497115 Other descriptive name: REVOLADE, PROMACTA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Glaxosmithkline Research and Development Ltd | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | Germany;Poland;Argentina;Czech Republic;United Kingdom;Italy;Russian Federation;Israel;Chile;Thailand;Spain;Taiwan;Hong Kong;United States | |||
58 | NCT01444417 | January 2012 | 16 December 2017 | 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 | Not recruiting | 1 Year | 17 Years | All | 62 | Phase 3 | United States;Australia;Canada | |
59 | NCT01549054 | January 2012 | 19 February 2015 | 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. | Not recruiting | 18 Years | 55 Years | Both | 28 | Phase 1 | United Kingdom | |
60 | JPRN-JMA-IIA00070 | 31/10/2011 | 2 April 2019 | 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 | Not Recruiting | >=20 YEARS | No Limit | BOTH | 24 | Phase 3 | Japan | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
61 | EUCTR2011-001354-29-DE | 12/10/2011 | 26 August 2013 | 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN FOR INTRAVENOUS USE Current Sponsor code: I10E Other descriptive name: human Immunoglobulin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | LFB BIOTECHNOLOGIES | Not Recruiting | Female: yes Male: yes | 40 | France;Hungary;Spain;Poland;Ukraine;Russian Federation;Germany;Italy | ||||
62 | EUCTR2009-014589-24-DE | 22/09/2011 | 6 October 2015 | 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: Immunglobulin CAS Number: 308067-58-5 Current Sponsor code: NewGam Other descriptive name: IMMUNOGLOBULIN G Concentration unit: % percent Concentration type: equal Concentration number: 10- | Octapharma AG | Not Recruiting | Female: yes Male: yes | 95 | Phase 3 | France;Czech Republic;Poland;Ukraine;Romania;Bulgaria;Russian Federation;Germany;India | |||
63 | NCT01437384 | September 2011 | 19 February 2015 | 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. | Not recruiting | 18 Years | 55 Years | Both | 36 | Phase 1 | United States | |
64 | EUCTR2011-000263-27-PL | 22/07/2011 | 3 November 2014 | 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® Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Normal Immunoglobulin G (IgG > 98% purity) Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Concentration unit: % percent Concentration type: equal Concentration number: 10- | CSL Behring LLC | Not Recruiting | Female: yes Male: yes | 150 | Bulgaria;Turkey;Poland;Serbia | ||||
65 | NCT01525836 | May 2011 | 2 May 2016 | 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 | Not recruiting | 18 Years | 72 Years | Both | 123 | Phase 3 | China |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
66 | NCT01327872 | February 2011 | 19 February 2015 | 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. | Not recruiting | 18 Years | 55 Years | Both | 84 | Phase 1 | Netherlands | |
67 | NCT01805648 | February 2011 | 19 February 2015 | 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 |
68 | NCT01416311 | December 21, 2010 | 4 November 2019 | Drug Use Investigation for REVOLADE (ITP) | Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura) | Purpura, Thrombocytopaenic, Idiopathic | Drug: Eltrombopag | Novartis Pharmaceuticals | Not recruiting | N/A | N/A | All | 1000 | Phase 1/Phase 2 | ||
69 | NCT01143038 | November 2010 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 75 | Phase 2 | United States;Australia;Czech Republic;France;Germany;Italy;Poland;Spain;United Kingdom | |
70 | NCT01356511 | September 2010 | 2 May 2016 | 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 | Not recruiting | 18 Years | 80 Years | Both | 261 | Phase 4 | China |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
71 | EUCTR2009-010421-39-DE | 10/03/2010 | 10 July 2015 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Product Name: Revolade Product Code: SB497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Product Name: Revolade Product Code: SB497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Revolade Product Code: SB497115 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ELTROMBOPAG CAS Number: 496775-61-2 Current Sponsor code: SB497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- | GlaxoSmithKline | Not Recruiting | Female: yes Male: yes | 200 | France;Hungary;Czech Republic;Germany;Italy | ||||
72 | EUCTR2009-014842-28-BE | 06/01/2010 | 8 August 2016 | 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 Pharmaceutical Form: Concentrate for solution for infusion Current Sponsor code: SM101 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | SuppreMol GmbH | Not Recruiting | Female: yes Male: yes | 51 | Phase 1;Phase 2 | Poland;Belgium;Germany | |||
73 | NCT03258866 | January 1, 2010 | 16 December 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 | Not recruiting | 10 Years | 70 Years | All | 62 | Phase 4 | China | |
74 | NCT01071954 | December 30, 2009 | 16 December 2017 | A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects 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 | Not recruiting | 1 Year | N/A | All | 66 | Phase 3 | United States;Australia;Canada;Spain | |
75 | NCT00908037 | September 2009 | 19 October 2017 | 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 | Not recruiting | 1 Year | 17 Years | All | 82 | Phase 2 | United States;Canada;France;Netherlands;Spain;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
76 | EUCTR2008-001597-33-NL | 18/06/2009 | 3 September 2018 | 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 Pharmaceutical Form: Solution for infusion Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | University Medical Center Utrecht | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Netherlands | |||
77 | EUCTR2008-004347-10-AT | 17/06/2009 | 10 March 2014 | 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: 9.1 Level: LLT Classification code 10021245 Term: Idiopathic thrombocytopenic purpura | Trade Name: Nplate Product Name: Romiplostim Product Code: AMG 531 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Romiplostim Current Sponsor code: AMG 531 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 500 deliverable- | Amgen Inc | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | Estonia;Slovenia;Spain;Lithuania;Austria;Italy;Czech Republic;Hungary;Poland;Belgium;Bulgaria;Germany;Sweden | |||
78 | NCT01506414 | June 2009 | 2 May 2016 | 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 | Not recruiting | 16 Years | 75 Years | Both | 91 | Phase 3 | China |
79 | NCT00888901 | May 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | 90 Years | Both | 30 | Phase 4 | Austria |
80 | EUCTR2008-005871-92-SE | 05/02/2009 | 19 March 2012 | 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 Pharmaceutical Form: Concentrate for solution for infusion | Sahlgrenska University Hospital | Authorised | Female: yes Male: yes | Sweden | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
81 | NCT00902018 | January 2009 | 1 April 2019 | 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 | Not recruiting | 18 Years | N/A | All | 20 | Phase 2 | United States |
82 | EUCTR2005-005918-20-FR | 23/12/2008 | 19 March 2012 | 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 Pharmaceutical Form: Concentrate for solution for infusion Other descriptive name: RITUXIMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use | Rikshospitalet | Authorised | Female: yes Male: yes | 110 | Phase 3 | United Kingdom;France;Sweden | |||
83 | EUCTR2004-000172-13-GB | 20/08/2008 | 31 July 2012 | 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 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: AMG 531 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.5- | Amgen Inc. | Authorised | Female: yes Male: yes | 350 | Czech Republic;Germany;United Kingdom;Belgium;Italy;Austria | ||||
84 | NCT00749112 | August 2008 | 19 February 2015 | 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 | Not recruiting | 16 Years | N/A | Both | 19 | Phase 2/Phase 3 | Mexico | |
85 | NCT00511147 | May 2008 | 16 December 2017 | 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. | Not recruiting | 3 Years | 70 Years | All | 64 | Phase 3 | United States;Canada;India;Puerto Rico |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
86 | NCT00828750 | May 2008 | 24 September 2018 | 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 | Not recruiting | 20 Years | N/A | All | 19 | Phase 3 | Japan | |
87 | EUCTR2007-000638-37-NL | 28/02/2008 | 19 March 2012 | 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 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Romiplostim Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 600- | Amgen Inc. | Not Recruiting | Female: yes Male: yes | 500 | United Kingdom;Czech Republic;Netherlands;Belgium;Spain;Ireland;Italy;Austria | ||||
88 | NCT00571467 | December 2007 | 20 August 2018 | 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. | Not recruiting | 18 Years | N/A | All | 9 | Phase 1 | Australia;New Zealand | |
89 | NCT00603642 | October 1, 2007 | 20 May 2019 | 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 | Not recruiting | 20 Years | N/A | All | 34 | Phase 3 | Japan | |
90 | EUCTR2007-003569-42-ES | 29/09/2007 | 19 March 2012 | 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 Pharmaceutical Form: Powder for solution for injection Current Sponsor code: AMG 531 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 600- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use | Amgen Inc. | Authorised | Female: yes Male: yes | 20 | Spain | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
91 | NCT00504075 | September 2007 | 19 October 2017 | 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 | Not recruiting | 18 Years | 70 Years | All | 35 | Phase 3 | United States;Argentina;India | |
92 | NCT00540423 | September 2007 | 19 October 2017 | 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 | Not recruiting | 20 Years | N/A | All | 23 | Phase 3 | Japan | |
93 | NCT00515203 | July 2007 | 19 October 2017 | 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 | Not recruiting | 1 Year | 17 Years | All | 22 | Phase 1/Phase 2 | Australia;Canada;Spain;United States | |
94 | NCT00362349 | June 2007 | 8 August 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 19 | Phase 3 | Australia | |
95 | NCT00475423 | May 2007 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 122 | Phase 2 | Australia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
96 | NCT00625443 | May 2007 | 11 June 2018 | 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. | Not recruiting | 18 Years | N/A | All | 53 | Phase 2 | United States | |
97 | EUCTR2006-002943-10-ES | 19/04/2007 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: eltrombopag CAS Number: CASRN496775 Current Sponsor code: SB-497115 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 25- Product Name: Eltrombopag Product Code: SB497115 Pharmaceutical Form: Tablet INN or Proposed INN: eltrombopag CAS Number: CASRN496775 Current Sponsor code: SB-497115 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50- | GlaxoSmithKline, S.A. | Authorised | Female: yes Male: yes | 50 | Germany;United Kingdom;Spain | ||||
98 | NCT00424177 | March 2007 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 66 | Phase 2 | Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States | |
99 | EUCTR2006-003700-18-AT | 05/02/2007 | 19 March 2012 | 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: AMG 531 Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 600- | Amgen Inc. | Not Recruiting | Female: yes Male: yes | 210 | Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria | ||||
100 | NCT00441090 | February 2007 | 19 February 2015 | 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: AKR-501 Tablets | Eisai Inc. | Not recruiting | 18 Years | N/A | Both | 64 | Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
101 | EUCTR2006-000470-78-FR | 22/12/2006 | 30 April 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: eltrombopag CAS Number: CASRN496775 Current Sponsor code: SB-497115 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Eltrombopag Product Code: SB497115 Pharmaceutical Form: Tablet INN or Proposed INN: eltrombopag CAS Number: CASRN496775 Current Sponsor code: SB-497115 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research and Development Limited | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | |||
102 | NCT00415532 | December 1, 2006 | 20 May 2019 | 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 | Not recruiting | 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 | |
103 | NCT00392951 | December 2006 | 19 November 2018 | 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 | Not recruiting | 1 Year | 30 Years | All | 30 | Phase 1/Phase 2 | United States | |
104 | NCT00370331 | November 2006 | 16 December 2017 | 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 | Not recruiting | 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 | |
105 | EUCTR2006-000470-78-NL | 30/10/2006 | 18 April 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). - 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 Pharmaceutical Form: Tablet INN or Proposed INN: eltrombopag CAS Number: CASRN496775 Current Sponsor code: SB-497115 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Eltrombopag Product Code: SB497115 Pharmaceutical Form: Tablet INN or Proposed INN: eltrombopag CAS Number: CASRN496775 Current Sponsor code: SB-497115 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research and Development Limited | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
106 | EUCTR2006-000471-14-SI | 13/06/2006 | 18 April 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Eltrombopag CAS Number: CASRN 496775 Current Sponsor code: SB497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- INN or Proposed INN: Eltrombopag CAS Number: CASRN 496775 Current Sponsor code: SB497115 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | GlaxoSmithKline Research and Development Limited | Not Recruiting | Female: yes Male: yes | 200 | Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece | ||||
107 | NCT00351468 | June 2006 | 16 December 2017 | 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 | Not recruiting | 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 | |
108 | NCT00426270 | June 2006 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 116 | Phase 3 | Austria | |
109 | EUCTR2005-003552-35-DE | 28/03/2006 | 19 March 2012 | 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% Pharmaceutical Form: Solution for infusion INN or Proposed INN: Human Immunoglobulin G Current Sponsor code: GAM10 Concentration unit: % percent Concentration type: equal Concentration number: 10- | Octapharma AG | Not Recruiting | Female: yes Male: yes | 116 | Czech Republic;Germany;France | ||||
110 | NCT00467571 | March 2006 | 19 February 2015 | 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 | Not recruiting | 2 Years | 18 Years | Both | 26 | Phase 4 | Thailand |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
111 | NCT00451594 | September 2005 | 19 February 2015 | 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 | Not recruiting | 16 Years | N/A | Both | 157 | Phase 3 | Korea, Republic of | |
112 | NCT00244257 | August 2005 | 20 April 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 10 | Phase 1 | United States | |
113 | NCT00770562 | July 2005 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 103 | Phase 3 | Italy | |
114 | EUCTR2005-000859-15-IT | 14/04/2005 | 19 March 2012 | 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 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Rituximab CAS Number: 174722-31-7 Current Sponsor code: RO 29-9800 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Mabthera Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Rituximab CAS Number: 174722-31-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | ROCHE | Not Recruiting | Female: yes Male: yes | Italy | |||||
115 | NCT00102336 | April 7, 2005 | 20 May 2019 | 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 | Not recruiting | 18 Years | N/A | All | 62 | Phase 3 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
116 | NCT00102323 | March 29, 2005 | 20 May 2019 | 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 | Not recruiting | 18 Years | N/A | All | 63 | Phase 3 | France;Netherlands;Spain;United States | |
117 | NCT00508820 | February 1, 2005 | 20 May 2019 | 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 | Not recruiting | 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 | |
118 | NCT00128882 | November 2004 | 19 February 2015 | 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. | Not recruiting | 1 Year | 14 Years | Both | 45 | Phase 2 | Denmark |
119 | NCT01713855 | October 2004 | 19 February 2015 | 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 | Not recruiting | 18 Months | 18 Years | Both | 10 | N/A | United States |
120 | NCT00116688 | August 2004 | 19 October 2017 | 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 | Not recruiting | 1 Year | N/A | All | 313 | Phase 3 | Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;United Kingdom;United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
121 | NCT00909077 | August 2004 | 30 September 2019 | 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 | Not recruiting | 18 Years | N/A | All | 155 | Phase 3 | Denmark | |
122 | NCT00161564 | February 2004 | 23 July 2018 | 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. | Not recruiting | 12 Years | N/A | All | 0 | Phase 2 | United States |
123 | NCT00111475 | June 2003 | 19 February 2015 | Evaluating the Safety and Efficacy of AMG531 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: AMG 531 | Amgen | Not recruiting | 18 Years | 65 Years | Both | Phase 2 | |||
124 | NCT01713738 | May 2003 | 19 February 2015 | 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 | Not recruiting | 18 Months | 18 Years | Both | 36 | Phase 1/Phase 2 | United States |
125 | NCT00162006 | January 1, 2003 | 29 January 2018 | 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 | Not recruiting | 18 Years | 65 Years | All | 28 | Phase 2 | Czechia;Germany;Hungary;Poland;Czech Republic | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
126 | NCT00151840 | October 2001 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 20 | Phase 3 | Poland | |
127 | NCT00107913 | September 2001 | 19 February 2015 | 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 | Recruiting | N/A | N/A | Both | 10 | Phase 2 | United States |