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 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00520494
Eligibility Criteria:
Key Inclusion Criteria:
* Written informed consent, age-adapted
* Male or female aged 1 to 70 years
* Diagnosis of primary humoral immunodeficiency
* No prior immunoglobulin substitution therapy
* IgG level of \<5 g/L at screening
* Women of childbearing potential must use medically approved contraception and must have a negative urine pregnancy test at screening
Key Exclusion Criteria:
* Evidence of serious infection between screening and first treatment
* Bleeding disorders that require medical treatments
* Any medical disorder causing secondary immune disorders, autoimmune neutropenia, or a clinically significant defect in cell mediated immunity
* Any condition likely to interfere with evaluation of the study drug or satisfactory conduct of the trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
70 Years
Study:
NCT00520494
Study Brief:
Protocol Section:
NCT00520494