Clinical trial
An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
Name
20050162
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.
Trial arms
Trial start
2006-02-01
Estimated PCD
2006-11-01
Trial end
2006-11-01
Status
Completed
Phase
Early phase I
Treatment
Romiplostim (AMG-531)
Romiplostim (AMG-531)
Arms:
romiplostim (AMG-531)
Size
12
Primary endpoint
Incidence of all adverse events including evaluation of antibody status
1 year
Eligibility criteria
Inclusion Criteria: - 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 Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2024-07-04
1 organization
1 product
1 indication
Organization
Kyowa KirinProduct
Romiplostim