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 @ 11:37 PM
Ignite Modification Date:
2025-12-24 @ 11:37 PM
NCT ID:
NCT00322556
Eligibility Criteria:
Key Inclusion Criteria:
Patients with CVID (Common Variable Immunodeficiency) or XLA (X-linked agammaglobulinemia) who:
Participated in the Phase III clinical study with intravenous IgPro10 (study number ZLB03\_002CR) at 3- or 4- weekly intervals for 12 months (referred to as 'old' subjects)
OR
Were ≥ 6 years of age, were on other stable intravenous immunoglobulin therapy (200-800 mg IgG per kg body weight) at 3- or 4-week intervals for at least 6 months, AND were interested in participating in the Phase III clinical study with subcutaneous IgPro20 (study number ZLB04\_009CR) (referred to as 'new' subjects)
Written informed consent
Key Exclusion Criteria:
Diagnosis of epilepsia
Insulin dependent diabetes
Administration of steroids (daily ≥ 0.15 mg prednisone equivalent/kg/day) or other immunosuppressive drugs
History of cardiac insufficiency (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
71 Years
Study:
NCT00322556
Study Brief:
Protocol Section:
NCT00322556