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Safety Study of AMG 531 in Japanese Subjects With ITP

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00305435
First Posted: March 22, 2006
Last Update Posted: September 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kyowa Hakko Kirin Co., Ltd
March 20, 2006
March 22, 2006
September 12, 2014
February 2006
November 2006   (Final data collection date for primary outcome measure)
Incidence of all adverse events including evaluation of antibody status [ Time Frame: 1 year ]
Incidence of all adverse events including evaluation of antibody status
Complete list of historical versions of study NCT00305435 on ClinicalTrials.gov Archive Site
Proportion of subjects who achieve a platelet response [ Time Frame: 2 weeks ]
Proportion of subjects who achieve a platelet response
Not Provided
Not Provided
 
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
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.
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Drug: Romiplostim (AMG-531)
Romiplostim (AMG-531)
Experimental: romiplostim (AMG-531)
Intervention: Drug: Romiplostim (AMG-531)
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2006
November 2006   (Final data collection date for primary outcome measure)
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
Not Provided
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00305435
20050162
No
Not Provided
Not Provided
Kyowa Hakko Kirin Co., Ltd
Kyowa Hakko Kirin Co., Ltd
Not Provided
Study Director: MD Amgen
Kyowa Hakko Kirin Co., Ltd
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP