Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects (NCT00634569) | Clinical Trial Compass
CompletedPhase 4
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
United States24 participantsStarted 2008-05
Plain-language summary
This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
Who can participate
Age range2 Years – 16 Years
SexALL
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Inclusion Criteria:
* The subject is between 2 and 16 years old, of either sex, belonging to any ethnic group, and above a minimum weight of 10 kg (this weight is based on the amount of blood required for testing).
* The subject has a primary immunodeficiency disease, (e.g., common variable immunodeficiency, X-linked and autosomal forms of agammaglobulinemia, hyper-IgM syndrome, Wiskott-Aldrich Syndrome).
* The subject has been receiving licensed IGIV replacement therapy at a dose that has not changed by + 50% of the mean dose on a mg/kg basis for at least 3 months before study entry and has maintained a trough level at least 300 mg/dL above baseline serum IgG levels.
* Trough levels of IgG, dose of IGIV, and treatment intervals for the last 2 consecutive routine IGIV treatments must be documented for each subject before the first infusion in this study can be administered.
* If a subject is an adolescent female (\> 12 years of age) who is or becomes sexually active, she must have a negative result on a pregnancy test (HCG-based assay).
* The subject, if old enough (generally 6 years to 16) has signed an informed Child Assent form and the subject's parent or legal guardian has signed an informed consent form, both approved by the Institutional Review Board.
Exclusion Criteria:
* Adult patient (\> 17 years old).
* The subject has a history of any severe anaphylactic reaction to blood or any blood-derived product.
* The subject is known to be intolerant to any component of t…