Status:
COMPLETED
Safety Study of AMG 531 in Japanese Subjects With ITP
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.
Detailed Description
The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.
Eligibility Criteria
Inclusion
- Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of health, labor and welfare
Exclusion
- Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00305435
Start Date
February 1 2006
End Date
November 1 2006
Last Update
July 5 2024
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