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 @ 5:02 PM
Ignite Modification Date:
2025-12-24 @ 5:02 PM
NCT ID:
NCT00511550
Eligibility Criteria:
Inclusion Criteria:
-Healthy adults
Exclusion Criteria:
* Pregnancy or uninterruptible breastfeeding.
* Sensitivity to filgrastim or to E. coli-derived recombinant protein products.
* History of autoimmune disorders, including rheumatic disease and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
* History of deep vein thrombosis or pulmonary embolism.
* Thrombocytopenia \<150 x 10(9)/L (\<150,000/uL) at baseline evaluation.
* Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been full evaluated.
* Positive Hemoglobin-Solubility (e.g. SickleDex or equivalent) test.
* Donors receiving experimental therapy or investigational agents.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT00511550
Study Brief:
Protocol Section:
NCT00511550