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 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 1:22 AM
NCT ID:
NCT00161993
Eligibility Criteria:
Inclusion Criteria:
Subjects will be eligible for study entry if they:
* are at least 18 years old
* have a form of primary immunodeficiency (PID) as described by Rosen et al, 1999 16 manifesting as agammaglobulinemia (X-linked) or hypogamma-globulinemia (common variable immunodeficiency), requiring immunoglobulin replacement therapy
* have had regular treatment for at least three months with either intravenous immunoglobulin preparations or immunoglobulin preparations for intramuscular use given subcutaneously
* have serum IgG levels greater than or equal to 5 g/L as determined by the local laboratory at screening
* if female of childbearing potential, agree to employ adequate birth control measures during the study
* have given written informed consent
Exclusion Criteria:
Subjects will not be eligible for study entry if they:
* had severe adverse reactions to treatment with immunoglobulin preparations during the last three treatments before inclusion into the study
* suffer from documented selective IgA deficiency with antibodies against IgA
* have an acute infection that requires intravenous antibiotic treatment (Last treatment day should be seven days before study entry.)
* are known to be infected with HIV, HCV, or HBV
* are at high risk of contracting blood-borne viral infections through parenteral drug abuse or life style
* suffer from congestive heart failure and receive on-demand treatment with furosemide
* show renal dysfunction defined as serum creatinine greater than or equal to 1.5 mg/dL at baseline visit
* received another investigational drug in the three weeks preceding study entry
* in case of females, are pregnant or nursing mothers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00161993
Study Brief:
Protocol Section:
NCT00161993