63. Idiopathic thrombocytopenic purpura Clinical trials / Disease details
Clinical trials : 391 / Drugs : 235 - (DrugBank : 50) / Drug target genes : 49 - Drug target pathways : 139
| 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 | NCT05653219 (ClinicalTrials.gov) | February 2, 2023 | 23/11/2022 | A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids | A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2) | Primary Immune Thrombocytopenia | Biological: Ianalumab;Drug: Eltrombopag;Drug: Placebo | Novartis Pharmaceuticals | NULL | Recruiting | 18 Years | N/A | All | 150 | Phase 3 | Czechia;Hungary;Korea, Republic of;Singapore;United Kingdom |
| 2 | EUCTR2022-001627-32-ES (EUCTR) | 23/01/2023 | 01/11/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Farmacéutica, S.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Philippines;Taiwan;Thailand;Spain;Italy;India;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Belgium;Singapore;Romania;Germany;Norway;Japan | ||
| 3 | EUCTR2022-001627-32-NL (EUCTR) | 29/12/2022 | 31/10/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Philippines;Taiwan;Thailand;Spain;Italy;India;France;Malaysia;Australia;Netherlands;China;Korea, Republic of;Czechia;Turkey;Austria;United Kingdom;Czech Republic;Hungary;Mexico;Argentina;Belgium;Singapore;Romania;Germany;Norway;Japan | ||
| 4 | EUCTR2022-001627-32-CZ (EUCTR) | 05/12/2022 | 20/10/2022 | A phase 3, randomized, double-blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids | A phase 3 randomized, double-blind study of ianalumab (VAY736) versus placebo in addition to eltrombopag in patients with primary immune thrombocytopenia (ITP) who had an insufficient response or relapsed after first line steroid treatment (VAYHIT2) - VAYHIT2 | immune thrombocytopenia (ITP) MedDRA version: 23.0;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Ianalumab Product Code: VAY736 INN or Proposed INN: Ianalumab | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | Singapore;United States;Czechia;Malaysia;Thailand;Austria;Netherlands;China;Korea, Republic of;France;Romania;Hungary;Japan;Philippines;United Kingdom;India;Spain;Czech Republic;Turkey;Belgium;Norway;Taiwan;Mexico;Italy;Australia;Germany | ||
| 5 | NCT05583838 (ClinicalTrials.gov) | November 22, 2022 | 12/10/2022 | A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts | Comparing the Efficacy and Safety of Optimized rhTPO Treatment Versus Eltrombopag Treatment in Previously Treated Primary Immune Thrombocytopenia Patients: A Multicenter Randomized Open-label Trial | Previously Treated Primary Immune Thrombocytopenia | Drug: rhTPO;Drug: Eltrombopag | Institute of Hematology & Blood Diseases Hospital | The Second Hospital of Hebei Medical University;Xijing Hospital;The Affiliated Hospital of Inner Mongolia Medical University;The Second Affiliated Hospital of Kunming Medical University;Second Affiliated Hospital of Guangzhou Medical University;Shaanxi Provincial People's Hospital;Henan Cancer Hospital;North China University of Science and Technology Affiliated Hospital;Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University;The Second Affiliated Hospital of Dalian Medical University;Second Hospital of Shanxi Medical University;The Second Affiliated Hospital of Harbin Medical University;Daqing Oil Field Hospital;Cangzhou Central Hospital;Yuncheng Central Hospital;Shenyang Sunshine Pharmaceutical Co., LTD. | Recruiting | 18 Years | 85 Years | All | 175 | Phase 4 | China |
| 6 | NCT04812483 (ClinicalTrials.gov) | September 1, 2022 | 1/3/2021 | Immunomodulation With Eltrombopag in ITP | Immunomodulation in Young and Midlife 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 | 55 Years | All | 24 | Phase 2 | Switzerland |
| 7 | NCT05369377 (ClinicalTrials.gov) | June 1, 2022 | 6/5/2022 | Zanubrutinib and Eltrombopag as Second-line Treatment in Adults With Primary Immune Thrombocytopenia | Zanubrutinib and Eltrombopag as Second-line Treatment for Patients With Immune Thrombocytopenia: a Multicentre, Open-label,Randomised, Controlled, Phase 2 Trial | Immune Thrombocytopenia | Drug: Zanubrutinib;Drug: Eltrombopag | Peking University People's Hospital | Beijing Hospital;The Sixth Medical Center of PLA General Hospital;Beijing Aerospace General Hospital;Qilu Hospital of Shandong University;Beijing Tongren Hospital | Not yet recruiting | 18 Years | 70 Years | All | 150 | Phase 2 | China |
| 8 | 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 |
| 9 | 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 |
| 10 | 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 |
| 11 | ChiCTR2000030603 | 2020-05-01 | 2020-03-08 | A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent immune thrombocytopenia | A multicenter prospective cohort clinical study of a short-course glucocorticoid therapy regimen for glucocorticoid-dependent 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 | Recruiting | 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 |
| 12 | 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 | |
| 13 | 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 |
| 14 | 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 |
| 15 | 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 |
| 16 | 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 | |
| 17 | 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 |
| 18 | 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 | ||
| 19 | 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 | |
| 20 | 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 | |||
| 21 | 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 | Phase 4 | United States;Taiwan;Hong Kong;Greece;Thailand;Spain;Ireland;Russian Federation;Israel;Italy;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Brazil;Tunisia;Netherlands;Germany;China;Korea, Republic of | ||
| 22 | 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 | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | 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 | ||
| 23 | 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 | ||
| 24 | 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 | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | 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 | ||
| 25 | 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;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 | ||
| 26 | 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 | ||
| 27 | 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 | ||
| 28 | 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 | ||
| 29 | 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 | ||
| 30 | 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 | ||
| 31 | 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 | ||
| 32 | 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 | |||
| 33 | 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 | |||
| 34 | 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 |
| 35 | 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 | |||
| 36 | 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 | ||
| 37 | 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 |
| 38 | 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 | ||
| 39 | 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 | ||
| 40 | 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 | |||
| 41 | 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 | |
| 42 | 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 | ||
| 43 | 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 | |||
| 44 | 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 | |||
| 45 | 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 | |||
| 46 | 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 |
| 47 | 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 | ||
| 48 | 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 | ||
| 49 | 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 | ||
| 50 | 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 |
| 51 | 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 |
| 52 | 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 | ||
| 53 | 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 |
| 54 | 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 | |||
| 55 | 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 | |||
| 56 | 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 | |||
| 57 | 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 | ||
| 58 | 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 | ||
| 59 | 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 | ||
| 60 | 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 | |||
| 61 | 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 | ||
| 62 | 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 | ||
| 63 | 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 | ||
| 64 | 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 | |||
| 65 | 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 |
| 66 | 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 | |||
| 67 | 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 | ||
| 68 | 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 | ||
| 69 | 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 | ||
| 70 | 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 | ||
| 71 | 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 | ||
| 72 | 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 | ||
| 73 | 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 | ||
| 74 | 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 | ||
| 75 | 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 | ||
| 76 | 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 | ||
| 77 | 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 |
| 78 | 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 | ||
| 79 | 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 | ||
| 80 | 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 | |||
| 81 | 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 | ||
| 82 | 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 | ||
| 83 | 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 | |||
| 84 | 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 |
| 85 | 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 |