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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT00024934
Eligibility Criteria:
INCLUSION CRITERIA:
Eligible subjects must meet the diagnostic criteria for IgA deficiency as defined by WHO or PAGID/ESID (Conley, 1999).
Diagnosis of IgA-D with recurrent or chronic sinopulmonary infection or chronic diarrhea/malabsorption.
Serum IgA at least 2 standard deviations below the mean at screening.
Eligible patients will be at least 18 years of age.
Liver function tests (SGOT, SGPT, alkaline phosphatase, total bilirubin) within 1.25 x upper limit of normal.
Serum creatinine within normal limits.
Patients must be able to understand and sign an informed consent form.
EXCLUSION CRITERIA:
A history of malignancy (other than adequately treated in situ carcinoma or non-melanotic skin cancer).
Active clinically-significant autoimmune manifestations within 2 years of study entry; any history of IgA nephropathy or Henoch-Schonlein purpura.
Pre-existing renal disease; proteinuria greater than trace at screening.
Symptomatic cardiac disease (greater than grade 1 NCI CTC) at screening. Patients with adequately treated well-controlled hypertension or minor arrythmias are eligible.
Pulmonary disease requiring treatment, bronchiectasis on baseline chest x-ray or FEV1 less than 75% normal limits at baseline evaluation. Patients with adequately treated well-controlled asthma are eligible.
Splenomegaly associated with cytopenias.
Significant cytopenias: Anemia (Hct less than 30%); Neutropenia (ANC less than 1500/microL); Thrombocytopenia (Platelets less than 75,000/mm(3)).
Biopsy-proven granulomatous disease.
B-lymphocyte count at screening less than 50/microL.
Use immune-based therapies (other than IVIG) such as chronic corticosteroid use, growth factors or other immune-modulating drugs within 4 weeks of screening (inhaled corticosteroids are permitted).
Pregnant female or nursing mother. (All females of childbearing potential must have had a negative blood or urine pregnancy test at screening. Over the course of the study, all female subjects must have practiced a method of contraception with greater than 90% reliability, or be sterile or postmenopausal.)
Participation in any clinical trial involving investigational or conventional drugs within 30 days of screening.
Known active hepatitis (testing not required for study entry).
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00024934
Study Brief:
Protocol Section:
NCT00024934