63. Idiopathic thrombocytopenic purpura Clinical trials / Disease details
Clinical trials : 363 / Drugs : 212 - (DrugBank : 43) / Drug target genes : 47 - Drug target pathways : 138
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04812483 (ClinicalTrials.gov) | May 2022 | 1/3/2021 | Immunomodulation With Eltrombopag in ITP | Immunomodulation in Young Adults With Newly Diagnosed Primary Immune Thrombocytopenia (ITP): A Randomized Open Label Trial With High-dose Dexamethasone Versus Eltrombopag and High-dose Dexamethasone | Primary Immune Thrombocytopenia (ITP) | Drug: Eltrombopag (Revolade®);Drug: standard therapy (without eltrombopag): HD-DXM | University Children's Hospital Basel | Stiftung zur Förderung medizinischer und biologischer Forschung;Novartis Pharmaceuticals;University of Erlangen-Nürnberg, Department of Biology | Recruiting | 18 Years | 45 Years | All | 24 | Phase 2 | Switzerland |
| 2 | ChiCTR2000040991 | 2022-03-02 | 2020-12-16 | Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study | Cyclosporine A combined with eltrombopag in the treatment for primary immune thrombocytopenia: a prospective, multicenter, single-arm, open clinical study | primary immune thrombocytopenia | experimental group:Cyclosporine A combined with eltrombopag; | The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Recruiting | 18 | 75 | Both | experimental group:28; | Phase 4 | China |
| 3 | NCT04890041 (ClinicalTrials.gov) | May 30, 2021 | 12/5/2021 | Avatrombopag in Primary Immune Thrombocytopenia (ITP) in Adults | Efficacy and Safety of Avatrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults With Poor Efficacy of Eltrombopag or rhTPO: a Single-center, Prospective, One-arm Study | Primary Immune Thrombocytopenic Purpura | Drug: Avatrombopag | Institute of Hematology & Blood Diseases Hospital | NULL | Recruiting | 18 Years | N/A | All | 20 | N/A | China |
| 4 | NCT04917679 (ClinicalTrials.gov) | September 1, 2020 | 1/12/2020 | Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP | Eltrombopag Plus Diacerein vs Eltrombopag in Adult Primary Immune Thrombocytopenia: a Multicenter Randomized Controlled Trial | Thrombocytopenia | Drug: Eltrombopag plus diacerein;Drug: Eltrombopag | Qilu Hospital of Shandong University | NULL | Recruiting | 18 Years | N/A | All | 100 | Phase 2 | China |
| 5 | NCT04518475 (ClinicalTrials.gov) | August 10, 2020 | 12/8/2020 | Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults | A Multicenter, Randomized, Open-label Study To Compare The Efficacy And Safety Of Eltrombopag Combining Rituximab With Eltrombopag In Adult ITP Patients | Primary Immune Thrombocytopenia (ITP) | Drug: eltrombopag combining rituximab;Drug: eltrombopag | Institute of Hematology & Blood Diseases Hospital | The Second Affiliated Hospital of Kunming Medical University;Henan Cancer Hospital;Tianjin Medical University Second Hospital;The First Affiliated Hospital of Xiamen University;Nantong University | Recruiting | 18 Years | 60 Years | All | 224 | Phase 4 | China |
| 6 | ChiCTR2000030603 | 2020-05-01 | 2020-03-08 | Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia | Clinical study on the safety and efficacy of short - course glucocorticoid treatment in patients with refractory glucocorticoid-dependent primary immune thrombocytopenia | Primary Immune Thrombocytopenia | The short -course glucocorticoid group:treat with glucocorticoid;The eltrombopag group:treat with eltrombopag;The rituximab group:treat with rituximab;Splenectomy group:treat with splenectomy;The azathioprine group:treat with azathioprine;The cyclosporine group:treat with cyclosporine; | The Second Affiliated Hospital of Kunming Medical University | NULL | Pending | 18 | 75 | Both | The short -course glucocorticoid group:65;The eltrombopag group:65;The rituximab group:65;Splenectomy group:65;The azathioprine group:65;The cyclosporine group:65; | Phase 4 | China |
| 7 | NCT04214951 (ClinicalTrials.gov) | January 1, 2020 | 28/12/2019 | A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia | A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia | Corticosteroid-resistant or Relapsed ITP | Drug: Eltrombopag;Drug: Recombinant human thrombopoietin (rh-TPO) | Peking University People's Hospital | NULL | Active, not recruiting | 18 Years | 75 Years | All | 100 | China | |
| 8 | NCT03771378 (ClinicalTrials.gov) | January 16, 2019 | 7/12/2018 | Efficacy and Safety of rhTPO and Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) | Efficacy and Safety of rhTPO and Eltrombopag in the Treatment of Chinese Adults With Primary Immune Thrombocytopenia (ITP):a Multicenter, Double-blind, Randomized, Controlled Trial | Primary Immune Thrombocytopenia | Drug: rhTPO;Drug: eltrombopag | Wuhan Union Hospital, China | The First Affiliated Hospital of Nanchang University;The Third Xiangya Hospital of Central South University;The First People's Hospital of Yuhang District;Xiangyang Central Hospital | Recruiting | 18 Years | 75 Years | All | 96 | Phase 4 | China |
| 9 | NCT03412188 (ClinicalTrials.gov) | August 1, 2018 | 20/1/2018 | The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP. | Evaluation of the Effect of Eltrombopag on the Expression of Platelet Collagen Receptor Glycoprotein VI (GPVI) in Pediatric Patients With Chronic and Persistent Immune Thrombocytopenia. | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: conventional | Nayera Hazaa Elsherif | NULL | Completed | 1 Year | 18 Years | All | 36 | N/A | Egypt |
| 10 | NCT03830749 (ClinicalTrials.gov) | July 1, 2018 | 1/2/2019 | Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura | A Pilot Study to Evaluate the Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone as First Line Therapy for Subjects With Idiopathic Thrombocytopenic Purpura (ITP) | Immune Thrombocytopenia | Drug: Eltrombopag | Humanity & Health Medical Group Limited | NULL | Suspended | 18 Years | N/A | All | 60 | Phase 2 | Hong Kong |
| 11 | NCT02298075 (ClinicalTrials.gov) | April 2016 | 17/11/2014 | Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia | Response Rate and Response Duration After Discontinuation of Treatment With Thrombopoietin Receptor Agonists in Patients Affected by Primary Immune Thrombocytopenia (pITP): Retrospective Study | Immune Thrombocytopenia | Drug: Eltrombopag;Drug: Romiplostin | Gruppo Italiano Malattie EMatologiche dell'Adulto | NULL | Unknown status | 18 Years | N/A | All | 100 | Italy | |
| 12 | NCT02402998 (ClinicalTrials.gov) | February 24, 2016 | 22/3/2015 | Eltrombopag in Second Line Adult Primary Immune Thrombosytopenia | Eltrombopag as Second Line Therapy in Adult Patients With Primary Immune Thrombocytopenia (ESTIT Study) in an Attempt to Achieve Long-term Remission: a Single Arm Multicenter Phase II Clinical and Biological Study | Primacy Immune Thrombocytopenia | Drug: Eltrombopag | Gruppo Italiano Malattie EMatologiche dell'Adulto | NULL | Completed | 18 Years | N/A | All | 55 | Phase 2 | Italy |
| 13 | EUCTR2015-001327-23-IT (EUCTR) | 26/06/2015 | 29/04/2015 | Study about the effect of a drug (Eltrombopag)which is administered in patients with thrombocytopenia primary Immune, a relative decrease of platelets in blood (small blood components that help the clotting process by sticking to the lining of blood vessels). | Eltrombopag as Second line Therapy in adult patients with primary Immune Thrombocytopenia (ESTIT study) in an attempt to achieve long-term remission: a single arm multicenter phase II clinical and biological study | Primary Immune Thrombocytopenia MedDRA version: 18.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Revolade INN or Proposed INN: NA Other descriptive name: ELTROMBOPAG OLAMINE Trade Name: Revolade Product Name: Revolade INN or Proposed INN: NA Other descriptive name: ELTROMBOPAG OLAMINE | Fondazione G.I.M.EM.A. Gruppo Italiano Malattie Ematologiche dell'Adulto | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 2 | Italy | ||
| 14 | ChiCTR1900021211 | 2015-04-01 | 2019-02-01 | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | A pilot study for evaluation of the safety and efficacy of eltrombopag plus pulsed dexamethasone as first line therapy for subjects with idiopathic thrombocytopenic purpura (ITP) | immune thrombocytopenia (ITP) | 1:eltrombopag 25-75mg daily for 3 months plus pulsed dexamethasone, 40mg daily for 4 days repeated every 4 weeks for 1-3 courses; | University Hospital, Macau | NULL | Recruiting | 18 | 100 | Both | 1:60; | China | |
| 15 | EUCTR2013-001371-20-NL (EUCTR) | 06/05/2014 | 19/03/2014 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Brazil;Poland;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 16 | EUCTR2013-001371-20-PL (EUCTR) | 11/04/2014 | 24/02/2014 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Thailand;Spain;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 17 | EUCTR2013-001371-20-GR (EUCTR) | 10/12/2013 | 11/11/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Tunisia;Netherlands;Germany;China;Korea, Republic of | |||
| 18 | EUCTR2013-001371-20-ES (EUCTR) | 15/10/2013 | 08/08/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 16.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 16.0;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of | ||
| 19 | EUCTR2013-001371-20-BE (EUCTR) | 15/10/2013 | 10/09/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 17.0;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 17.0;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Relovade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Tunisia;Germany;China;Korea, Republic of | |||
| 20 | EUCTR2013-001371-20-IE (EUCTR) | 06/09/2013 | 11/07/2013 | A study to provide continued access of eltrombopag to subjects who are currently participating in a GlaxoSmithKline sponsored investigational study with eltrombopag (parent study) | Study 200170: A Rollover Study to Provide ContinuedTreatment with Eltrombopag - Eltrombopag rollover protocol | Acute myelogenous leukemia & Idiopathic thrombocytopenic purpura (ITP MedDRA version: 14.1;Level: LLT;Classification code 10000886;Term: Acute myeloid leukemia;System Organ Class: 100000004864 MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Cancer [C04] | Trade Name: REVOLADE Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Trade Name: Revolade Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | United States;Hong Kong;Taiwan;Greece;Spain;Thailand;Ireland;Israel;Russian Federation;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Netherlands;Germany;Tunisia;China;Korea, Republic of | ||
| 21 | EUCTR2011-000831-10-DE (EUCTR) | 18/07/2012 | 16/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 22 | EUCTR2011-000831-10-BE (EUCTR) | 16/07/2012 | 15/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 23 | EUCTR2011-000831-10-GB (EUCTR) | 02/07/2012 | 28/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 24 | EUCTR2011-000831-10-AT (EUCTR) | 05/06/2012 | 16/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 25 | EUCTR2011-000831-10-ES (EUCTR) | 25/05/2012 | 29/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Korea, Republic of;Sweden | ||
| 26 | EUCTR2011-000831-10-NL (EUCTR) | 24/05/2012 | 24/05/2012 | A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune Thrombocytopenia | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled,Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 versus Eltrombopag, in Adults with Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable | Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Product Name: E5501 Product Code: E5501 INN or Proposed INN: Avatrombopag maleate Other descriptive name: AKR-501, YM-477 Trade Name: Revolade 25 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta Trade Name: Revolade 50 mg film-coated tablets INN or Proposed INN: eltrombopag Other descriptive name: eltrombopag olamine, Revolade, Promacta | Eisai Limited | NULL | Not Recruiting | Female: yes Male: yes | 286 | Phase 3 | United States;Taiwan;Spain;Ireland;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden;Korea, Republic of | ||
| 27 | EUCTR2011-002184-17-DE (EUCTR) | 04/05/2012 | 13/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | |||
| 28 | EUCTR2011-002184-17-PL (EUCTR) | 17/04/2012 | 08/03/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | |||
| 29 | NCT01433978 (ClinicalTrials.gov) | March 26, 2012 | 13/9/2011 | A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura) | A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: Avatrombopag;Drug: Standard of care | Eisai Inc. | NULL | Terminated | 18 Years | 99 Years | All | 24 | Phase 3 | United States |
| 30 | EUCTR2011-002184-17-IT (EUCTR) | 07/03/2012 | 08/03/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP).PETIT2: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT2 | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD. | NULL | Not Recruiting | Female: yes Male: yes | 75 | United States;Taiwan;Hong Kong;Thailand;Spain;Russian Federation;Chile;Israel;Italy;United Kingdom;Argentina;Poland;Germany | |||
| 31 | EUCTR2011-002184-17-GB (EUCTR) | 02/03/2012 | 17/01/2012 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: E | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Taiwan;Hong Kong;Spain;Thailand;Russian Federation;Chile;Israel;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 32 | NCT01520909 (ClinicalTrials.gov) | March 2012 | 21/12/2011 | Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. | A Two Part, Double-blind, Randomized, Placebo-controlled and Open-label Study to Investigate the Efficacy, Safety and Tolerability of Eltrombopag, a Thrombopoietin Receptor Agonist, in Pediatric Patients With Previously Treated Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITP | Idiopathic Thrombocytopenic Purpura | Drug: Eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 1 Year | 17 Years | All | 92 | Phase 3 | United States;Argentina;Czech Republic;Germany;Hong Kong;Israel;Italy;Poland;Russian Federation;Spain;Taiwan;Thailand;United Kingdom;Chile |
| 33 | EUCTR2011-002184-17-ES (EUCTR) | 23/02/2012 | 21/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | Pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG | Glaxosmithkline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 34 | EUCTR2011-002184-17-CZ (EUCTR) | 08/02/2012 | 08/12/2011 | Study of a new medication for childhood chronic immune thrombocytopenic purpura, ITP, a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A two part, double-blind, randomized, placebo-controlled and open-label study to investigate the efficacy, safety and tolerability of eltrombopag, a thrombopoietin receptor agonist, in pediatric patients with previously treated chronic immune (idiopathic) thrombocytopenic purpura (ITP). - A two part,PETIT2: Eltrombopag in PEdiatric patients with hrombocytopenia from ITP | To assess the efficacy of eltrombopag, relative to placebo, in achieving platelet counts of = 50 Gi/L, when administered to pediatric subjects with previously treated chronic ITP during the first 12 weeks of Part 1, the randomized treatment period. MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA Product Name: ELTROMBOPAG Product Code: SB-497115 INN or Proposed INN: ELTROMBOPAG Other descriptive name: REVOLADE, PROMACTA | Glaxosmithkline Research and Development Ltd | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 3 | United States;Hong Kong;Taiwan;Spain;Thailand;Chile;Israel;Russian Federation;Italy;United Kingdom;Czech Republic;Argentina;Poland;Germany | ||
| 35 | EUCTR2006-002946-13-NL (EUCTR) | 19/04/2011 | 15/12/2010 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | France;Spain;Netherlands;United Kingdom | |||
| 36 | NCT01416311 (ClinicalTrials.gov) | December 21, 2010 | 9/6/2011 | Drug Use Investigation for REVOLADE (ITP) | Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura) | Purpura, Thrombocytopaenic, Idiopathic | Drug: Eltrombopag | Novartis Pharmaceuticals | NULL | Completed | N/A | N/A | All | 5797 | NULL | |
| 37 | EUCTR2009-010421-39-FR (EUCTR) | 25/05/2010 | 09/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: eltrombopag (Revolade) Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;Hungary;Czech Republic;Germany;Italy | ||
| 38 | EUCTR2009-010421-39-CZ (EUCTR) | 06/05/2010 | 03/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Hungary;Czech Republic;Germany;Italy | |||
| 39 | EUCTR2009-010421-39-HU (EUCTR) | 05/05/2010 | 10/03/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 12.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 150 | France;Czech Republic;Hungary;Germany;Italy | |||
| 40 | EUCTR2009-010421-39-DE (EUCTR) | 10/03/2010 | 04/02/2010 | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | A longitudinal 2-year bone marrow study of eltrombopag olamine (SB-497115-GR) in previously treated adults, with chronic immune (idiopathic) thrombocytopenic purpura (ITP). | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 15.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG Product Name: Revolade Product Code: SB497115 INN or Proposed INN: ELTROMBOPAG | GlaxoSmithKline | NULL | Not Recruiting | Female: yes Male: yes | 200 | France;Hungary;Czech Republic;Germany;Italy | |||
| 41 | NCT00908037 (ClinicalTrials.gov) | September 30, 2009 | 21/5/2009 | Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) | A Three Part, Staggered Cohort, Open-label and Double Blind, Randomized, Placebo Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of Eltrombopag, a Thrombopoietin Receptor Agonist, in Previously Treated Pediatric Patients With Chronic ITP. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 1 Year | 17 Years | All | 82 | Phase 2 | United States;Canada;France;Netherlands;Spain;United Kingdom |
| 42 | EUCTR2006-002946-13-FR (EUCTR) | 18/09/2009 | 05/08/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;Spain;Netherlands;United Kingdom | ||
| 43 | EUCTR2006-002946-13-GB (EUCTR) | 18/09/2009 | 06/07/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP). Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Netherlands;United Kingdom | ||
| 44 | EUCTR2006-002946-13-ES (EUCTR) | 30/07/2009 | 06/07/2009 | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITPEstudio abierto, doble ciego, aleatorizado, controlado con placebo, de cohortes escalonadas , con tres partes para investigar la eficacia, seguridad, tolerabilidad y farmacocinética de eltrombopag, un agonista del receptor de trombopoyetina, en pacientes pediátricos con púrpura trombocitopénica idiopática (PTI) crónica previamente tratados.Eltrombopag PETIT: Eltrombopag en pacientes pediátricos con trombocitopenia por PTI (Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP) - PETIT | Chronic Idiopathic Thrombocytopenic PurpuraPúrpura Trombocitopénica Idiopática Crónica MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag | GlaxoSmithKline S.A. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 2 | France;Spain;Netherlands;United Kingdom | ||
| 45 | NCT00888901 (ClinicalTrials.gov) | May 2009 | 27/4/2009 | Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag | Assessment of Platelet Function in Patients With Chronic Autoimmune Thrombocytopenic Purpura (cAITP) Treated With the Thrombopoietin Receptor (MPL) Agonist Eltrombopag. | Idiopathic Thrombocytopenic Purpura | Drug: eltrombopag;Drug: corticosteroids (Aprednislon) | Ingrid Pabinger, MD | GlaxoSmithKline | Completed | 18 Years | 90 Years | Both | 30 | Phase 4 | Austria |
| 46 | NCT00902018 (ClinicalTrials.gov) | January 2009 | 8/5/2009 | Eltrombopag and the Bcl-extra-large (xL) Pathway in Idiopathic Thrombocytopenic Purpura (ITP) | The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) Pathway | Immune Thrombocytopenia | Drug: Eltrombopag;Drug: Romiplostim;Other: healthy controls | Weill Medical College of Cornell University | GlaxoSmithKline | Completed | 18 Years | N/A | All | 20 | Phase 2 | United States |
| 47 | EUCTR2006-000471-14-IE (EUCTR) | 02/08/2008 | 05/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 4 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 48 | NCT00828750 (ClinicalTrials.gov) | May 2008 | 22/1/2009 | Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)-An Extension Study of Eltrombopag in Subjects, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study TRA108109 (NCT00540423)- | Idiopathic Thrombocytopenic Purpura;Purpura, Thrombocytopenic, Idiopathic | Drug: Eltrombopag oral tablets | GlaxoSmithKline | NULL | Completed | 20 Years | N/A | All | 19 | Phase 3 | Japan |
| 49 | EUCTR2006-000471-14-FI (EUCTR) | 30/11/2007 | 08/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 50 | EUCTR2006-000471-14-IT (EUCTR) | 16/11/2007 | 13/09/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study. - TRA105325 | Idiopathic thrombocytopenic purpura MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag Product Name: Eltrombopag Product Code: SB-497115-GR INN or Proposed INN: Eltrombopag | GLAXOSMITHKLINE R&D LTD | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 51 | EUCTR2006-000471-14-AT (EUCTR) | 11/11/2007 | 23/10/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 52 | EUCTR2006-000471-14-DE (EUCTR) | 26/10/2007 | 30/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 53 | EUCTR2006-000471-14-DK (EUCTR) | 01/10/2007 | 14/08/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 54 | EUCTR2006-000470-78-CZ (EUCTR) | 01/10/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 55 | EUCTR2006-000471-14-CZ (EUCTR) | 16/08/2007 | 24/07/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 56 | EUCTR2006-002943-10-ES (EUCTR) | 19/04/2007 | 21/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Spain;Germany;United Kingdom | ||
| 57 | EUCTR2006-002943-10-GB (EUCTR) | 13/04/2007 | 26/02/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom | ||
| 58 | EUCTR2006-000470-78-GR (EUCTR) | 27/03/2007 | 03/01/2007 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 59 | EUCTR2006-002943-10-DE (EUCTR) | 16/03/2007 | 28/03/2007 | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | REPEAT. Repeated ExPosure To Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura. An Open-label repeat dosing study of eltrombopag olamine (SB-497115-GR) in adult subjects, with chronic idiopathic thrombocytopenic purpura (ITP) - REPEAT | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 50 | United Kingdom;Germany;Spain | |||
| 60 | NCT00424177 (ClinicalTrials.gov) | March 2007 | 17/1/2007 | Repeated Exposure to Eltrombopag in Adults With Idiopathic Thrombocytopenic Purpura (REPEAT) | An Open-label Repeat Dosing Study of Eltrombopag Olamine (SB-497115-GR) in Adult Subjects, With Chronic Idiopathic Thrombocytopenic Purpura (ITP) | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 66 | Phase 2 | Germany;Russian Federation;Australia;Canada;India;Korea, Republic of;Netherlands;Spain;Tunisia;United Kingdom;United States |
| 61 | EUCTR2006-000471-14-GR (EUCTR) | 27/02/2007 | 04/09/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | |||
| 62 | EUCTR2006-000470-78-DE (EUCTR) | 14/02/2007 | 05/12/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Czech Republic;Germany;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 63 | EUCTR2006-000471-14-SK (EUCTR) | 23/01/2007 | 30/11/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 17.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 64 | EUCTR2006-000470-78-IT (EUCTR) | 17/01/2007 | 05/02/2007 | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | RAISE RAndomized placebo-controlled ITP Study with Eltrombopag A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine SB-497115-GR , a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura ITP . - RAISE RAndomized placebo-controlled ITP Study with Eltrombopag | Idiopathic thrombocytopenic purpura ITP MedDRA version: 9.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB-497115-GR Product Name: Eltrombopag Product Code: SB-497115-GR | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 65 | EUCTR2006-000470-78-SK (EUCTR) | 17/01/2007 | 30/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 66 | EUCTR2006-000470-78-FR (EUCTR) | 22/12/2006 | 16/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 67 | EUCTR2006-000470-78-FI (EUCTR) | 12/12/2006 | 25/10/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 68 | EUCTR2006-000470-78-DK (EUCTR) | 29/11/2006 | 10/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | France;Czech Republic;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;United Kingdom;Italy | ||
| 69 | EUCTR2006-000470-78-AT (EUCTR) | 22/11/2006 | 20/11/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 70 | EUCTR2006-000470-78-ES (EUCTR) | 22/11/2006 | 13/04/2012 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | United States;Hong Kong;Estonia;Taiwan;Slovakia;Greece;Spain;Russian Federation;Italy;Vietnam;India;France;Denmark;Peru;Netherlands;Tunisia;China;Finland;Austria;United Kingdom;Czech Republic;Canada;Brazil;Poland;Germany;New Zealand | ||
| 71 | EUCTR2006-000470-78-GB (EUCTR) | 22/11/2006 | 08/05/2008 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Czech Republic;Slovakia;Greece;Finland;Spain;Austria;Denmark;Germany;Netherlands;Italy;United Kingdom | ||
| 72 | NCT00370331 (ClinicalTrials.gov) | November 2006 | 29/8/2006 | RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag | A Randomized, Double-blind, Placebo-controlled Phase III Study, to Evaluate the Efficacy, Safety and Tolerability of Eltrombopag Olamine (SB-497115-GR), a Thrombopoietin Receptor Agonist, Administered for 6 Months as Oral Tablets Once Daily in Adult Subjects With Previously Treated Chronic ITP. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 197 | Phase 3 | United States;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;India;Italy;Netherlands;New Zealand;Peru;Poland;Russian Federation;Slovakia;Spain;Taiwan;Tunisia;Ukraine;United Kingdom;Vietnam;Estonia |
| 73 | EUCTR2006-000470-78-NL (EUCTR) | 30/10/2006 | 01/09/2006 | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | A randomized, double-blind, placebo-controlled phase III study, to evaluate the efficacy, safety and tolerability of eltrombopag olamine (SB-497115-GR), a thrombopoietin receptor agonist, administered for 6 months as oral tablets once daily in adult subjects with previously treated chronic idiopathic thrombocytopenic purpura (ITP). - RAISE | Idiopathic thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 3 | Finland;United Kingdom;Germany;Czech Republic;Netherlands;France;Spain;Italy;Greece;Austria | ||
| 74 | EUCTR2006-000471-14-GB (EUCTR) | 23/10/2006 | 03/06/2007 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune Thrombocytopenic Purpura (ITP) MedDRA version: 12.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 75 | EUCTR2006-000471-14-NL (EUCTR) | 23/08/2006 | 21/07/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Slovenia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Netherlands;Germany;Sweden | |||
| 76 | EUCTR2006-000471-14-SE (EUCTR) | 14/08/2006 | 29/05/2006 | Extension study to evaluate the safety and efficacy of eltrombopag for the treatment of subjects with idiopathic thrombocytopenic purpura (ITP) who have previously been enrolled in an eltrombopag trial. | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | chronic immune (idiopathic) thrombocytopenic purpura (ITP) MedDRA version: 18.0;Level: LLT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 100000004851;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Trade Name: Revolade Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | United States;Taiwan;Hong Kong;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Italy;Vietnam;France;Peru;Australia;Denmark;Tunisia;Netherlands;China;Korea, Republic of;Slovenia;Pakistan;Finland;Austria;United Kingdom;Czech Republic;Canada;Poland;Romania;Germany;New Zealand;Sweden | ||
| 77 | EUCTR2006-000471-14-FR (EUCTR) | 16/06/2006 | 24/11/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) MedDRA version: 8.1;Level: LLT;Classification code 10051057;Term: Idiopathic thrombocytopenia | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovenia;Slovakia;Greece;Finland;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Denmark;Germany;Netherlands;Sweden | ||
| 78 | EUCTR2006-000471-14-SI (EUCTR) | 13/06/2006 | 23/05/2006 | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study - EXTEND | Immune thrombocytopenic purpura (ITP) | Product Name: Eltrombopag Product Code: SB497115 INN or Proposed INN: Eltrombopag INN or Proposed INN: Eltrombopag | GlaxoSmithKline Research and Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 200 | Germany;Netherlands;France;Ireland;Italy;Austria;Sweden;Finland;United Kingdom;Czech Republic;Slovenia;Denmark;Spain;Greece | |||
| 79 | NCT00351468 (ClinicalTrials.gov) | June 2006 | 10/7/2006 | EXTEND (Eltrombopag Extended Dosing Study) | EXTEND (Eltrombopag Extended Dosing Study): An Extension Study of Eltrombopag Olamine (SB-497115-GR) in Adults, With Idiopathic Thrombocytopenic Purpura (ITP), Previously Enrolled in an Eltrombopag Study. | Purpura, Thrombocytopaenic, Idiopathic | Drug: eltrombopag olamine (SB-497115-GR) | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 302 | Phase 3 | United States;Australia;Austria;Canada;China;Czech Republic;Denmark;Finland;France;Germany;Greece;Hong Kong;Italy;Korea, Republic of;Netherlands;New Zealand;Pakistan;Peru;Poland;Romania;Russian Federation;Slovakia;Slovenia;Spain;Sweden;Taiwan;Thailand;Tunisia;Ukraine;United Kingdom;Vietnam;India;Ireland;Mexico;Norway |
| 80 | EUCTR2006-002946-13-Outside-EU/EEA (EUCTR) | 24/02/2012 | A study of a new medication, eltrombopag, for the treatment of childhood chronic immune thrombocytopenic purpura (ITP), a blood disorder of low platelet counts that can lead to bruising easily, bleeding gums, and/or bleeding inside the body. | A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric patients with chronic idiopathic thrombocytopenic purpura (ITP).Eltrombopag PETIT: Eltrombopag in PEdiatric patients with Thrombocytopenia from ITP - PETIT | Chronic Idiopathic Thrombocytopenic Purpura MedDRA version: 14.1;Level: PT;Classification code 10021245;Term: Idiopathic thrombocytopenic purpura;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA Product Name: Eltrombopag Product Code: SB-497115 INN or Proposed INN: Eltrombopag Other descriptive name: REVOLADE, PROMACTA | GlaxoSmithKline Research & Development Limited | NULL | NA | Female: yes Male: yes | 70 | Canada;United States |