Safety Study of AMG 531 in Japanese Subjects With ITP

An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00305435

Enrollment

Registered

2006-03-22

Start date

2006-02-28

Completion date

2006-11-30

Last updated

2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

AMG 531, ITP, Phase 2, Japanese

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.

Interventions

DRUGRomiplostim (AMG-531)

Romiplostim (AMG-531)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of all adverse events including evaluation of antibody status	1 year

Secondary

Measure	Time frame
Proportion of subjects who achieve a platelet response	2 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026