Safety Study of AMG 531 in Japanese Subjects With ITP

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier:
NCT00305435
First received: March 20, 2006
Last updated: September 11, 2014
Last verified: September 2014
  Purpose

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 Kyowa Hakko Kirin Company, Limited:

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.

  Eligibility

Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305435

Sponsors and Collaborators
Kyowa Hakko Kirin Company, Limited
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
Publications:
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: Kyowa Hakko Kirin Company, Limited
ClinicalTrials.gov Identifier: NCT00305435     History of Changes
Other Study ID Numbers: 20050162
Study First Received: March 20, 2006
Last Updated: September 11, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyowa Hakko Kirin Company, Limited:
AMG 531, ITP, Phase 2, Japanese

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Thrombocytopenia
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhage
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on October 30, 2014