Status:
COMPLETED
Romiplostim (AMG 531) Versus Medical Standard of Care for Immune (Idiopathic) Thrombocytopenic Purpura
Lead Sponsor:
Amgen
Conditions:
Idiopathic Thrombocytopenic Purpura
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This is a phase 3b, multi-center, randomized, Standard of Care (SOC)-controlled, open-label, 52-week treatment study to compare romiplostim to medical SOC for Idiopathic Thrombocytopenia Purpura (ITP)...
Eligibility Criteria
Inclusion
- Subject is ≥ 18 years of age
- Subject has a diagnosis of Idiopathic Thrombocytopenia Purpura (ITP) according to the American Society of Hematology (ASH) guidelines
- If subject is \> 60 years of age, subject has a written bone marrow biopsy report confirming the diagnosis of ITP
- Subject has received at least 1 prior therapy for ITP
- Subject has a platelet count \< 50,000 or their platelet count falls to \< 50,000 during or after a clinically-indicated taper or discontinuation of current ITP therapy
- Before any study-specific procedure, the appropriate written informed consent must be obtained
Exclusion
- Subject has had a splenectomy for any reason
- Subject has an active malignancy
- Subject has a history of cancer, other than basal cell carcinoma or cervical carcinoma in situ, with treatment or active disease within 5 years
- Subject has a known history of bone marrow stem cell disorder
- Subject has participated in any study evaluating polyethylene glycol-conjugated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin (rHuTPO), AMG 531, or a thrombopoietic protein
- Subject is receiving other investigational agents or procedures
- Subject is currently enrolled in, or has completed within the last 30 days, another investigational device or drug study
- Subject is pregnant or breast feeding
- Subject is not using adequate contraceptive precautions
- Subject has known sensitivity to any recombinant E. coli-derived product
- Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and does not have a legally acceptable representative
- Subject has any kind of disorder that compromises the ability of the subject to comply with study procedures
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2009
Estimated Enrollment :
234 Patients enrolled
Trial Details
Trial ID
NCT00415532
Start Date
December 1 2006
End Date
May 11 2009
Last Update
November 8 2022
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