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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT00902018
Eligibility Criteria:
Inclusion Criteria:
* Subject has signed and dated a written informed consent
* Male or female adults (≥18 years) diagnosed with either primary ITP according to the American Society for Hematology or British Committee for Standards in Haematology (ASH/BCSH) guidelines \[Blood, 1996; British Journal of Haematology, 2003\] for at least three months prior to study entry or with ITP secondary to Evans syndrome, systemic lupus erythematosus (SLE), or Common Variable Immunodeficiency (including hypogammaglobulinemia).
* Subjects must have responded with a platelet count \> 30,000/µL to a previous ITP therapy including thrombopoietic agents.
* Platelet count \< 30,000/µL
* Female subjects of childbearing potential are practicing an acceptable method of contraception or are completely abstinent from intercourse.
Exclusion Criteria:
* Active infection
* Previously treated with thrombopoietic agents IF either no response at a therapeutic dose (peak platelet count \< 50k) OR treatment with the agent within the past 4 weeks
* Currently treated with concomitant ITP medication that has not been stable in dose for at least 2 weeks - only prednisone, azathioprin, and danazol are allowed.
* Female subjects who are nursing or pregnant
* Thrombosis of any kind within past 6 months or on blood thinners because of thrombosis.
* Intravenous Immunoglobulin (IVIG), IV anti-D, bolus corticosteroids or vinca alkaloids within the past week
* Other cytotoxic or immunosuppressive ITP therapy within the past 8 weeks or rituximab within the past 12 weeks
* Active non-dermatologic malignancy defined as presence of known tumor ie. visible by radiography or evident on blood or bone marrow testing OR receiving chemotherapy within past 2 months
* Hemoglobin \< 10 gm/dl or white blood cell count \< 2,500/ul
* Liver function tests (ALT, Aspartate Aminotransferase (AST), or total bilirubin) \> three times upper limit of normal (ULN)
* Creatinine \> two times upper limit of normal (ULN)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00902018
Study Brief:
Protocol Section:
NCT00902018