Status:
COMPLETED
Open Label Extension Study of Romiplostim (AMG 531) in Thrombocytopenic Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Lead Sponsor:
Amgen
Conditions:
Thrombocytopenia
Idiopathic Thrombocytopenic Purpura
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the safety of romiplostim as a long-term treatment in thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to romiplostim, and to e...
Eligibility Criteria
Inclusion
- Must have previously completed a romiplostim ITP study
- Platelet count ≤ 50 x 10 \^9/L
- Written informed consent
Exclusion
- Bone marrow stem cell disorder or new active malignancies diagnosed since enrollment in the previous romiplostim ITP study
- Received any alkylating agents within 4 weeks before screening visit or anticipated use during the time of the proposed study
- Currently enrolled in or has not yet completed at least 4 weeks since ending device or drug trial(s) (other than the previous romiplostim ITP study), or subject is receiving other investigational agent(s) other than romiplostim
- Not using adequate contraceptive precautions
- Not available for follow-up assessments
- Has any kind of disorder that compromises the ability of the participant to give informed consent and does not have a legally-acceptable representative and/or is unable to comply with study procedures.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
313 Patients enrolled
Trial Details
Trial ID
NCT00116688
Start Date
August 1 2004
End Date
January 1 2010
Last Update
December 18 2013
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