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 @ 3:09 AM
Ignite Modification Date:
2025-12-25 @ 3:09 AM
NCT ID:
NCT01199705
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of PID with hypo- or agammaglobulinemia requiring IgG replacement therapy
* Intravenous IgG (IVIG) therapy at regular 3- or 4-week intervals at a stable dose for at least 3 doses prior to signing of informed consent
* Written informed consent
Exclusion Criteria:
* Newly diagnosed PID, i.e., subjects who have not previously received immunoglobulin replacement therapy
* Ongoing serious bacterial infections (SBIs: pneumonia, bacteremia/septicemia, osteomyelitis/septic arthritis, bacterial meningitis, or visceral abscess) at the time of screening
* Ongoing or history of concomitant malignancies of lymphoid cells such as lymphocytic leukemia, non-Hodgkin's lymphoma, and immunodeficiency with thymoma
* Allergic or other severe reactions to immunoglobulins or other blood products recorded in the past 3 months or at the time of screening
* Pregnancy or nursing mother
* A positive result at screening on any of the following viral markers: human immunodeficiency virus-1 (HIV-1), HIV-2, hepatitis C virus, or hepatitis B virus
* Participation in a study with other investigational product during this study and within 3 months prior to screening
* Subjects who donated blood (200 mL within one month or 400 mL within 3 months prior to screening), or planning to donate blood during the study
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
75 Years
Study:
NCT01199705
Study Brief:
Protocol Section:
NCT01199705