NCT00305435CompletedPhase 2
An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Kyowa Kirin Co., Ltd.
- Enrollment
- 12
- Primary Endpoint
- Incidence of all adverse events including evaluation of antibody status
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
romiplostim (AMG-531)
Experimental
Intervention: Romiplostim (AMG-531) (Drug)
Outcomes
Primary Outcomes
Incidence of all adverse events including evaluation of antibody status
Time Frame: 1 year
Secondary Outcomes
- Proportion of subjects who achieve a platelet response(2 weeks)
Investigators
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