AVATROMBOPAG MALEATE ( DrugBank: Avatrombopag )
1 disease
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 63 | 特発性血小板減少性紫斑病 | 10 |
63. 特発性血小板減少性紫斑病
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 | EUCTR2020-003232-24-DE (EUCTR) | 11/03/2021 | 27/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Sobi, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | France;United States;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 2 | EUCTR2020-003232-24-PL (EUCTR) | 29/12/2020 | 28/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Sobi, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | United States;France;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 3 | EUCTR2020-003232-24-FR (EUCTR) | 03/12/2020 | 02/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Dova Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | United States;France;Hungary;Czech Republic;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 4 | EUCTR2020-003232-24-HU (EUCTR) | 11/11/2020 | 20/10/2020 | Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia | A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for =6 Months | Thrombocytopenia in paediatric subjects with immune thrombocytopenia for =6 months duration who have had an insufficient response to a previous treatment MedDRA version: 20.0;Level: HLT;Classification code 10043555;Term: Thrombocytopenias;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 23.0;Level: LLT;Classification code 10083843;Term: Primary immune thrombocytopenia;Level: PT;Classification code 10083842;Term: Immune thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders MedDRA version: 20.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Trade Name: Doptelet 20 mg film-coated tablets Product Name: avatrombopag INN or Proposed INN: Avatrombopag maleate Other descriptive name: AVATROMBOPAG MALEATE | Sobi, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | France;United States;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 5 | 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 | ||
| 6 | 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 | ||
| 7 | 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 | ||
| 8 | 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 | ||
| 9 | 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 | ||
| 10 | 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 |