63. 特発性血小板減少性紫斑病 Idiopathic thrombocytopenic purpura Clinical trials / Disease details
臨床試験数 : 391 / 薬物数 : 235 - (DrugBank : 50) / 標的遺伝子数 : 49 - 標的パスウェイ数 : 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 | 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 |
| 2 | 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 | ||
| 3 | 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 | |||
| 4 | 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 | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 | ||
| 11 | 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 | ||
| 12 | 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 | ||
| 13 | 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 | ||
| 14 | 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 | |||
| 15 | 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 | |||
| 16 | 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 | |||
| 17 | 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 | ||
| 18 | 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 | ||
| 19 | 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 | ||
| 20 | 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 | |
| 21 | 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 | ||
| 22 | 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 | |||
| 23 | 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 | |||
| 24 | 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 | |||
| 25 | 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 | ||
| 26 | 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 | ||
| 27 | 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 |