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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00001905
Eligibility Criteria:
PARTICIPANT INCLUSION CRITERIA:
Leukocyte Adhesion Deficiency type I, as determined by flow cytometry showing less than 10% CD18 expression in association with typical signs of LAD I .
Weight adequate to permit the blood drawing requirements of the protocol, greater than 13 kg.
Patients should be without serious, ongoing, uncontrolled infections.
Adequate hematopoietic, renal and hepatic function, defined as:
Absolute neutrophil count greater than or equal to 1500/microL;
Hemoglobin greater than or equal to 7g/dL (post transfusion or erythropoeitin);
Platelet count greater than or equal to 100,000/microL;
Creatinine less than or equal to 1.5 x upper limit of normal;
Bilirubin less than or equal to 1.5 x upper limit of normal;
AST/SGOT less than or equal to 2.5 x upper limit of normal;
ALT/SGPT less than or equal to 2.5 x upper limit of normal;
Calculated Creatinine Clearance greater than or equal to 60 mL/min.
Karnofsky Performance Status Index greater than or equal to 70.
Written signed informed consent.
PARTICIPANT EXCLUSION CRITERIA:
HIV infection.
Active malignancy.
Symptomatic cardiac disease or ongoing treatment for same.
Pregnant or lactating women.
Surgery during the two weeks prior to the start of IFN-gamma dosing.
Concurrent use of systemic corticosteroids, except for physiologic replacement.
Exposure to any investigational drug within four weeks prior to the start of dosing.
Any other major illness which, in the investigator's judgement, may substantially increase the risk associated with the patients participation in this study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00001905
Study Brief:
Protocol Section:
NCT00001905