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:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT00508820
Eligibility Criteria:
Inclusion Criteria:
* Subject is ≥ 18 years of age
* Subject has a diagnosis of immune (idiopathic) thrombocytopenic purpura per the American Society of Hematology guidelines
* If Subject is \> 60 years of age, subject has a written bone marrow aspiration and/or biopsy report consistent with a diagnosis of ITP
* Subject has received at least 1 prior therapy for ITP
* Subject's platelet count is ≤ 30,000 or the subject is experiencing bleeding that is uncontrolled with conventional therapies
* Subject (or legally-acceptable representative) is willing and able to provide written informed consent
Exclusion Criteria:
* Subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (MDS), or bone marrow stem cell disorder
* Subject has participated in any study evaluating PEG-rHuMGDF, recombinant human thrombopoietin (rHuTPO), or related platelet product
* Subject has a known hypersensitivity to any recombinant E coli-derived product
* Subject has received any therapeutic drug or device that is not approved by the local regulatory health agency for any indication within 4 weeks of Screening
* Subject is of reproductive potential and is not using adequate contraceptive precautions, in the judgment of the investigator
* Subject is pregnant or breast feeding
* Investigator has concerns regarding the subject's ability to comply with the protocol procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00508820
Study Brief:
Protocol Section:
NCT00508820