Doptelet (DrugBank: -)
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 | 3 |
| 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-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 | Dova Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 3 | United States;France;Czech Republic;Hungary;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | ||
| 2 | EUCTR2020-003232-24-PL (EUCTR) | 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 | Dova Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 72 | Phase 3 | United States;France;Hungary;Czech Republic;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom | |||
| 3 | EUCTR2020-003232-24-DE (EUCTR) | 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 | Dova Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 72 | Phase 3 | United States;France;Hungary;Czech Republic;Poland;Ukraine;Turkey;Russian Federation;Germany;United Kingdom |