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 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT00472433
Eligibility Criteria:
Inclusion Criteria:
1. Patients must have a diagnosis of the following autoimmune cytopenias:
immune thromobocytopenia purpura (ITP) autoimmune hemolytic anemia (AIHA) autoimmune neutropenia (AIN) pure red cell aplasia (PRCA) and
2. Patients must have refractory disease according to the following criteria
1. not respond to steroids or
2. need prednisolone more than 15 mg/d for maintenance therapy
3. Complete work up for baseline evaluation and measurement
4. Age \> 18 years
5. Patient's free written inform consent
Exclusion Criteria:
1. Patients with a known hypersensitivity to murine proteins or to any component of alemtuzumab
2. Patients with poor performance status (ECOG criteria of 3-4)
3. Serologic evidence of human immunodeficiency virus exposure
4. Patients with active uncontrolled infection. Patients that are HIV positive or test positive on HBs or HCV antigens.
5. Pregnant or lactating women
6. Serious medical or psychiatric illness which prevent informed consent
7. Patients who are likely to lost to follow up (eg, unwilling or difficult to return, cannot be contacted)
8. Patients with active malignancies
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00472433
Study Brief:
Protocol Section:
NCT00472433