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 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT00039650
Eligibility Criteria:
INCLUSION CRITERIA:
Both male and female subjects will be studied.
Subjects will be enrolled without regard to their ethnic group.
Only adults and children 18 years of age or older will be studied.
Subjects must weigh at least 110 pounds.
EXCLUSION CRITERIA:
Any subject that does not pass the health criteria for blood donors established by the American Association of Blood Banks will be excluded.
Subjects will be excluded if they have any of the following conditions: pregnancy, uncontrolled hypertension, heart disease, history of allergic reactions to G-CSF, history of allergic reactions to E. coli, abnormal hemoglobin or white blood cell counts, a malignancy, or asthma.
Subjects with family members with conditions that may require a transplant in the future will be excluded.
Subjects with an enlarged spleen by history or physical exam will be excluded.
Subjects with hemoglobin less than 12.5 or greater than 19.0 gm/dL, platelet counts less than 150 x 10(9)/L or greater than 500 x 10(9)/L and an absolute neutrophil count of less than 1.5 x 10(9)/L or greater than 10.0 x 10(9)/L will not be eligible.
Subjects with an abnormal EKG will be excluded from the study.
Pregnant and lactating women will be excluded.
If a subject's veins are judged to be too small to support the intravenous catheter required for the procedure, they will be excluded.
If at the time of each apheresis procedure the nurses are unable to obtain adequate antecubital vein access, the subject will be excluded.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT00039650
Study Brief:
Protocol Section:
NCT00039650