63. 特発性血小板減少性紫斑病 [臨床試験数:311,薬物数:185(DrugBank:39),標的遺伝子数:43,標的パスウェイ数:132

Searched query = "Idiopathic thrombocytopenic purpura", "Primary immune thrombocytopenia"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
17 trials found
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-GR16/11/201208/10/2012A 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: 15.0Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 15.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 15.0Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 15.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem 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-NL28/08/201223/08/2011A 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: 16.1Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem 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
3NCT01433978March 26, 201213/9/2011A 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 PurpuraDrug: Eltrombopag;Drug: Avatrombopag;Drug: Standard of careEisai Inc.NULLTerminated18 Years99 YearsAll24Phase 3United States
4EUCTR2011-000830-12-CZ19/01/201203/11/2011A 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: 14.1Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem 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
5EUCTR2011-000830-12-PL16/01/201217/11/2011A 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: 16.1Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 16.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem 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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2011-000830-12-BE30/12/201120/09/2011A 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: 14.1Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem 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
7EUCTR2011-000830-12-BG21/12/201112/12/2011A 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: 14.1Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem 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
8EUCTR2011-000830-12-SK28/09/201126/08/2011A 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: 14.0Level: PTClassification code 10043554Term: ThrombocytopeniaSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0Level: HLGTClassification code 10035534Term: Platelet disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders
MedDRA version: 14.0Level: LLTClassification code 10036735Term: Primary thrombocytopeniaSystem 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
9EUCTR2006-003700-18-PT04/06/200706/02/2007A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
10EUCTR2006-003700-18-CZ25/05/200707/02/2007A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;United Kingdom;Czech Republic;Netherlands;Belgium;France;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2006-003700-18-DE08/05/200725/04/2007A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Czech Republic;United Kingdom;Germany;Netherlands;Belgium;France;Italy;Austria
12EUCTR2006-003700-18-BE26/03/200721/03/2007A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
13EUCTR2006-003700-18-GB08/03/200701/01/2007A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3Portugal;France;Czech Republic;Belgium;Austria;Netherlands;Germany;Italy;United Kingdom
14EUCTR2006-003700-18-AT05/02/200721/12/2006A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
15EUCTR2006-003700-18-FR31/01/200711/01/2007A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2006-003700-18-NL29/01/200712/09/2007A Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open- label Study Evaluating the Efficacy and Tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura Immune (idiopathic) thrombocytopenic purpura (ITP)
MedDRA version: 8.1Level: PTClassification code 10021245Term: Idiopathic thrombocytopenic purpura
Product Name: AMG 531
Product Code: AMG 531
INN or Proposed INN: AMG 531
Amgen Inc.NULLNot RecruitingFemale: yes
Male: yes
210Portugal;Germany;Czech Republic;United Kingdom;Netherlands;Belgium;France;Italy;Austria
17NCT00415532December 1, 200621/12/2006Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic PurpuraA Randomized, Controlled, Open-label Study Evaluating the Efficacy and Tolerability of AMG 531 Versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects With Immune (Idiopathic) Thrombocytopenic PurpuraIdiopathic Thrombocytopenic Purpura;Thrombocytopenia;Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP);Thrombocytopenic PurpuraDrug: Medical Standard of Care for ITP;Biological: RomiplostimAmgenNULLCompleted18 YearsN/AAll234Phase 3Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Italy;Netherlands;Poland;Spain;Switzerland;United Kingdom;United States