Status:
COMPLETED
Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
Lead Sponsor:
Kyowa Kirin Co., Ltd.
Conditions:
Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
20+ years
Phase:
PHASE2
PHASE3
Brief Summary
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 to...
Detailed Description
Romiplostim was administered by subcutaneous (SC) injection once per week. If subjects entered the extension study within 12 weeks from the last investigational product administration in the previous ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00440037
Start Date
November 1 2006
End Date
September 1 2011
Last Update
January 21 2020
Active Locations (13)
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1
Research Site
Sapporo, Hokkaido, Japan, 060-8648
2
Research Site
Tsukuba, Ibaraki, Japan, 305-8576
3
Research Site
Isehara-shi, Kanagawa, Japan, 259-1193
4
Research Site
Sagamihara, Kanagawa, Japan, 228-8555