Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT00415532
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00415532
Study Brief:
Protocol Section:
NCT00415532