This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5%
DIF in the pediatric population.
Minimum age: 2 Years.
Maximum age: 16 Years.
- 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
- 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.
- Adult patient (> 17 years old).
- The subject has a history of any severe anaphylactic reaction to blood or any
- The subject is known to be intolerant to any component of the products, such as
sorbitol (i. e., intolerance to fructose).
- The subject has selective IgA deficiency or has demonstrable antibodies to IgA.
- The subject is currently receiving, or has received, any investigational agent within
the prior 3 months.
- The subject has been exposed to blood or any blood product or derivative within the
last 6 months, other than a commercially available IGIV.
- The adolescent subject is pregnant or is nursing.
- The subject, at screening, has levels greater than 2. 5 times the upper limit of
normal as defined at the central laboratory for pediatric patients of any of the
- The subject has a severe pre-existing renal impairment (defined by serum creatinine
greater than 2 times the ULN or BUN greater than 2. 5 times the ULN for that
laboratory, or any subject who is on dialysis) or any history of acute renal failure.
- The subject has a history of DVT or thrombotic complications of IGIV therapy.
- The subject suffers from any acute or chronic medical condition (e. g., renal disease
or predisposing conditions for renal disease, coronary artery disease, or protein
losing state) that, in the opinion of the Investigator, may interfere with the
conduct of the study.
- The subject has an acquired medical condition such as lymphocytic leukemia, chronic
or recurrent neutropenia (ANC less than 1000), or AIDS known to cause secondary
immune deficiency, or is s/p hematopoetic stem cell transplantation.
- The subject is receiving the following medication:
- Systemic corticosteroids (long-term, i. e., not intermittent or burst, daily, >
1 mg of prednisone equivalent/kg/day). Topical steroids (ie- nasal, inhaled for
asthma, and/or skin preparations for eczema) are not exclusionary.
- Immunosuppressive drugs
- Immunomodulatory drugs
- The subject has non-controlled arterial hypertension (systolic blood pressure > 160
mm Hg and/or diastolic blood pressure > 100 mm Hg).
- The subject has anemia (hemoglobin < 10 g/dL) at screening.
- The subject and/or parent/legal guardian of the subject is unlikely to adhere to the
protocol requirements of the study or is likely to be uncooperative or unable to
provide from the patient a storage serum sample at the screening visit. (Please note,
a pre-treatment serum sample to be stored at - 94° F (-70º C) for possible future
testing is absolutely required).
University of South Florida, St. Petersburg, Florida 33701-4899, United States
Family Allergy & Asthma Center, PC, Atlanta, Georgia 30342, United States
Rush University Medical Center, Chicago, Illinois, United States
The Allergy and Asthma Center, Fort Wayne, Indiana 46804, United States
The Children's Hospital of Buffalo, Buffalo, New York 14222, United States
Pennsylvania State University, Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States
Children's Hospital and Regional Medial Center, Seattle, Washington 98195-7110, United States