A Randomized, Controlled, Open-Label Study Evaluating the efficacy and tolerability of AMG 531 versus Medical Standard of Care as Chronic Therapy for Non-splenectomized Subjects with Immune (Idiopathic) Thrombocytopenic Purpura. - 20060131
- Conditions
- Immune (idiopathic) thrombocytopenic purpura (ITP)MedDRA version: 6.1Level: PTClassification code 10021245
- Registration Number
- EUCTR2006-003700-18-IT
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 210
Subject is >= 18 years of age ? Subject has a diagnosis of ITP according to 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 x 109/L or their platelet count falls to < 50 x 109/L 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
? 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 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method