Safety Study of AMG 531 in Japanese Subjects With ITP

This study has been completed.
Information provided by (Responsible Party):
Amgen Identifier:
First received: March 20, 2006
Last updated: March 5, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Drug: Romiplostim (AMG-531)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Resource links provided by NLM:

Further study details as provided by Amgen:

Primary Outcome Measures:
  • Incidence of all adverse events including evaluation of antibody status [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of subjects who achieve a platelet response [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: February 2006
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: romiplostim (AMG-531) Drug: Romiplostim (AMG-531)
Romiplostim (AMG-531)

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.


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

  Contacts and Locations
Please refer to this study by its identifier: NCT00305435

Sponsors and Collaborators
Study Director: MD Amgen
  More Information

Additional Information:
Shirasugi Y, Ando K, Hashino S, Nagasawa T, Kurata Y, Kishimoto Y, Iwato K, Sonehara Y, Ohtsu T, Berger D.A phase 2, open-label, sequential-cohort, dose-escalation study of romiplostim in Japanese patients with chronic immune thrombocytopenic purpura.Journal-001279;2009;90(2):157-65

Responsible Party: Amgen Identifier: NCT00305435     History of Changes
Other Study ID Numbers: 20050162
Study First Received: March 20, 2006
Last Updated: March 5, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Amgen:
AMG 531, ITP, Phase 2, Japanese

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases processed this record on April 16, 2014