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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
Kyowa Kirin Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

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

    First Posted
    March 20, 2006
    Last Updated
    September 11, 2014
    Sponsor
    Kyowa Kirin Co., Ltd.
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    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

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    Safety Study of AMG 531 in Japanese Subjects With ITP

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