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Study Complete
Sponsor ID
20060113

Open Label Extension Study of AMG 531 in Japanese Subjects with ITP

Sponsor ID
20060113
Clinicaltrials.gov ID
NCT00440037
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

The purpose of this study is to assess the safety and efficacy of long term dosing of AMG 531 in thrombocytopenic Japanese subjects with ITP.

It is anticipated that AMG 531 will be a safe and well tolerated in long term treatment and that AMG 531 will effectively raise and maintain platelet counts to a desired therapeutic range, when individual dose adjustments based on platelet counts are permitted.

This study is available to subjects who have completed any previous AMG 531 ITP study in Japan and meet the eligibility criteria of this study.

Additional Study Details

Phase
Phase 2/Phase 3
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
44
Additional Study Details

Protocol Summary

Primary Outcome Measures

The primary endpoint is the incidence of all adverse events including clinically significant changes in laboratory values.

Timeframe: Entire duration of the study

Secondary Outcome Measures

Incidence of anti AMG 531 antibody formation

Timeframe: Entire duration of the study

Incidence of platelet response (platelet response is defined as a doubling of baseline platelet counts and more than 50 x 10^9/L; baseline platelet counts is that obtained in the previous study)

Timeframe: Entire duration of the study

Proportion of subjects able to reduce or discontinue their concurrent ITP therapies (for subjects that are receiving oral corticosteroids at a constant dose and schedule at the screening visit)

Timeframe: Entire duration of the study

Change from baseline in PRO endpoints at each time point (baseline PRO is obtained at Day 1 predose)

Timeframe: Entire duration of the study

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Sapporo, Hokkaido, Japan, 060-8648
Status
Completed
Location
Research Site
Tsukuba, Ibaraki, Japan, 305-8576
Status
Recruiting
Location
Research Site
Isehara-shi, Kanagawa, Japan, 259-1193
Status
Completed
Location
Research Site
Suita, Osaka, Japan, 565-0871
Status
Recruiting
Location
Research Site
Hirakata, Japan, 573-1191
Status
Recruiting
Location
Research Site
Hiroshima, Hiroshima, Japan, 730-8619
Status
Recruiting
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Study Info
Age
20+ years
Condition
  • Thrombocytopenia
    • Sex
    All
    Trial Dates
    Oct 2006 - N/A
    Inclusion and Exclusion Criteria
    Inclusion Criteria - Subjects must have previously completed an AMG 531 ITP study in Japan. - Platelet count taken at the screening visit must be < 50 x 109/L. - Before any study-specific procedure, the appropriate written informed consent must be obtained. Exclusion Criteria - Any significant change in medical history since completion of the previous AMG 531 ITP study including bone marrow stem cell disorders or new active malignancies - known positive result from a test for neutralizing antibodies to AMG 531 in the previous AMG 531 ITP study - Currently receiving any treatment for ITP except oral corticosteroids, azathioprine and/or danazol administered at a constant dose and schedule from at least 4 weeks prior to the screening visit - received intravenous immunoglobulin, anti-D immunoglobulin, or any drug administered to increase platelet counts (eg, immunosuppressants etc) within 1 week before the screening visit - received anti-malignancy agents (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, Interferon-alfa etc) within 4 weeks before the screening visit - received any monoclonal antibody drugs (eg, rituximab etc) within 8 weeks before the screening visit - Less than 4 weeks since receipt of any therapeutic drug or device that is not Ministry of Health, Labor and Welfare (MHLW) approved for any indication before the screening visit (excluding AMG 531) - Pregnant or breast feeding - Subjects of reproductive potential who are not using adequate contraceptive precautions, in the judgment of the investigator - known severe drug hypersensitivity - Concerns for subject’s compliance with the protocol