Status:
COMPLETED
Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Lead Sponsor:
Amgen
Conditions:
Thrombocytopenic Purpura
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune throm...
Eligibility Criteria
Inclusion
- Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP
- 2 of 3 pretreatment platelet counts that were less than 30 x 10\^9/L (if not currently on ITP therapy) or less than 50 x 10\^9/L (if currently receiving corticosteroids for ITP therapy)
- Ability to give informed consent
Exclusion
- Known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder
Key Trial Info
Start Date :
December 2 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2004
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00117143
Start Date
December 2 2002
End Date
July 19 2004
Last Update
June 26 2023
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