Safety Study of AMG 531 in Japanese Subjects With ITP

Phase 2

Completed

• Conditions: Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Interventions: Drug: Romiplostim (AMG-531)

• Registration Number: NCT00305435
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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 Timeline

• Study Start: 2006-02
• Study First Submitted: 2006-03-20
• Study First Submitted QC: 2006-03-20
• Study First Posted: 2006-03-22
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-03
• Last Update Posted: 2024-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
romiplostim (AMG-531)	Romiplostim (AMG-531)	-

Primary Outcome Measures

Name	Time	Method
Incidence of all adverse events including evaluation of antibody status	1 year

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve a platelet response	2 weeks