Avatrombopag (proposed) ( DrugBank: Avatrombopag )


1 disease
IDDisease name (Link within this page)Number of trials
63Idiopathic thrombocytopenic purpura7

63. Idiopathic thrombocytopenic purpura


Clinical trials : 363 Drugs : 212 - (DrugBank : 43) / Drug target genes : 47 - Drug target pathways : 138
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-000830-12-GR
(EUCTR)
16/11/201208/10/2012A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 15.0;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 15.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;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 (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hong Kong;Slovakia;Greece;Ukraine;Czech Republic;Poland;Belgium;Singapore;Romania;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
2EUCTR2011-000830-12-NL
(EUCTR)
28/08/201223/08/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;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 (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Belgium;Poland;Ukraine;Singapore;Australia;Bulgaria;South Africa;Netherlands;New Zealand
3EUCTR2011-000830-12-CZ
(EUCTR)
19/01/201203/11/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;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 (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Czech Republic;Slovakia;Greece;Poland;Belgium;Ukraine;Singapore;Australia;South Africa;Bulgaria;Netherlands;New Zealand
4EUCTR2011-000830-12-PL
(EUCTR)
16/01/201217/11/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 16.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;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 (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
49Phase 3Slovakia;Greece;Ukraine;Austria;Czech Republic;Poland;Belgium;Singapore;Romania;South Africa;Bulgaria;Netherlands;New Zealand
5EUCTR2011-000830-12-BE
(EUCTR)
30/12/201120/09/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;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 (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Hungary;Czech Republic;Belgium;Poland;Portugal;Hong Kong;Slovakia;Greece;Ukraine;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China
6EUCTR2011-000830-12-BG
(EUCTR)
21/12/201112/12/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.1;Level: HLGT;Classification code 10035534;Term: Platelet disorders;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1;Level: PT;Classification code 10043554;Term: Thrombocytopenia;Level: LLT;Classification code 10036735;Term: Primary thrombocytopenia;Level: SOC;Classification code 10005329;Term: Blood and lymphatic system disorders;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 (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Hong Kong;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;Bulgaria;South Africa;Netherlands;New Zealand;China
7EUCTR2011-000830-12-SK
(EUCTR)
28/09/201126/08/2011A Study on the Effect of E5501 (study drug) in Adults with Chronic Immune ThrombocytopeniaA Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults with Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura) - Not applicable Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
MedDRA version: 14.0;Level: PT;Classification code 10043554;Term: Thrombocytopenia;System Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0;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 (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Product Name: E5501
Product Code: E5501
INN or Proposed INN: Avatrombopag (proposed)
Other descriptive name: AKR-501, YM-477
Eisai LimitedNULLNot RecruitingFemale: yes
Male: yes
84Phase 3Portugal;Slovakia;Greece;Ukraine;Hungary;Czech Republic;Poland;Belgium;Singapore;Romania;Croatia;Australia;South Africa;Bulgaria;Netherlands;New Zealand;China