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 @ 4:34 PM
Ignite Modification Date:
2025-12-24 @ 4:34 PM
NCT ID:
NCT00220766
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of primary immune deficiency and medical records available for retrospective review for at least 3 months prior to entry into the trial
* Signed an informed consent written informed consent prior to initiation of any study related procedures
* Receiving regular infusions of IGIV at a fixed interval and dosage (in the range of 200-600 mg/kg given every 3-4 weeks) for at least three months prior to entry into the trial. Patients who are currently receiving less than 400 mg/kg are eligible for this trial and will be at the time of study enrollment be treated at 400 mg/kg
Exclusion Criteria:
* History or suspicion of significant allergic reaction to intravenous immune globulin, and/or blood products
* Documented history of selective IgA deficiency (serum level \<5.0 mg/dL) and known antibodies to IgA
* Isolated IgG subclass deficiency with a normal total serum IgG level
* Other conditions which may interfere with the trial, include the patients demeanor or mental ability to follow instruction.
* Pretreatment with anti-pyretics or anti-histamines
* Congestive heart failure (New York Heart Association stage greater than Class II)
* Renal insufficiency (creatinine \>2.5 mg/dL)
* Conditions whose symptoms and effects could alter protein catabolism and/or IgG utilization (e.g. protein-losing enteropathies, nephrotic syndrome)
* Pretreatment routinely required to control/ameliorate IGIV infusion-related adverse events (AEs)
* Any patient who requires IGIV dosing more frequently than every 3 weeks to maintain adequate trough levels
* Women of child bearing potential who do not practice adequate contraception (i.e. chemical or mechanical methods) and pregnant or lactating females
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00220766
Study Brief:
Protocol Section:
NCT00220766