Safety Study of AMG 531 in Japanese Subjects With ITP

Kyowa Kirin Co., Ltd.12 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Interventions

Romiplostim (AMG-531)DRUG

Romiplostim (AMG-531)

Eligibility

Sex: ALLMin age: 20 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

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

Time frame: 2 weeks

Data from ClinicalTrials.gov

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