Safety Study of AMG 531 in Japanese Subjects With ITP

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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00305435
• Other study ID #: 20050162
• Status: Completed
• Phase: Phase 2
• First received: March 20, 2006
• Last updated: September 11, 2014
• Start date: February 2006
• Est. completion date: November 2006

Study information

• Verified date: September 2014
• Source: Kyowa Hakko Kirin Company, Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Thrombocytopenia
• Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
• Thrombocytosis

Intervention

Drug:
• Romiplostim (AMG-531)
Romiplostim (AMG-531)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyowa Hakko Kirin Company, Limited

References & Publications (1)

Shirasugi Y, Ando K, Hashino S, Nagasawa T, Kurata Y, Kishimoto Y, Iwato K, Ohtsu T, Berger DP. A phase II, open-label, sequential-cohort, dose-escalation study of romiplostim in Japanese patients with chronic immune thrombocytopenic purpura. Int J Hematol. 2009 Sep;90(2):157-65. doi: 10.1007/s12185-009-0361-y. Epub 2009 Jun 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all adverse events including evaluation of antibody status		1 year	Yes
Secondary	Proportion of subjects who achieve a platelet response		2 weeks	No

External Links

•   AmgenTrials clinical trials website
•   FDA-approved Drug Labeling