Safety Study of AMG 531 in Japanese Subjects With ITP
Primary Purpose
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Romiplostim (AMG-531)
Sponsored by
About this trial
This is an interventional treatment trial for Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) focused on measuring AMG 531, ITP, Phase 2, Japanese
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
romiplostim (AMG-531)
Arm Description
Outcomes
Primary Outcome Measures
Incidence of all adverse events including evaluation of antibody status
Secondary Outcome Measures
Proportion of subjects who achieve a platelet response
Full Information
NCT ID
NCT00305435
First Posted
March 20, 2006
Last Updated
September 11, 2014
Sponsor
Kyowa Kirin Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00305435
Brief Title
Safety Study of AMG 531 in Japanese Subjects With ITP
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kyowa Kirin Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Keywords
AMG 531, ITP, Phase 2, Japanese
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
romiplostim (AMG-531)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Romiplostim (AMG-531)
Intervention Description
Romiplostim (AMG-531)
Primary Outcome Measure Information:
Title
Incidence of all adverse events including evaluation of antibody status
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieve a platelet response
Time Frame
2 weeks
10. Eligibility
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19543952
Citation
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):157-165. doi: 10.1007/s12185-009-0361-y. Epub 2009 Jun 20.
Results Reference
background
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
URL
http://download.veritasmedicine.com/REGFILES/amgen/Amgen_results_disclaimer.pdf
Description
Notice regarding posted summaries of trial results
URL
http://download.veritasmedicine.com/REGFILES/amgen/08D_FDAMA_113_Posting_Summary_46_AMP-2_20050162.pdf
Description
To access clinical trial results information click on this link
URL
http://www.nplate.com/
Description
FDA-approved Drug Labeling
Learn more about this trial
Safety Study of AMG 531 in Japanese Subjects With ITP
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