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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00634569
Date of registration: 05/03/2008
Prospective Registration: Yes
Primary sponsor: Instituto Grifols, S.A.
Public title: Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
Scientific title: Evaluation of the Efficacy and Safety of Flebogamma 5% DIF [Immune Globulin Intravenous (Human)] for Replacement Therapy in Pediatric Subjects With Primary Immunodeficiency Diseases.
Date of first enrolment: May 2008
Target sample size: 24
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00634569
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Mark Ballow, MD
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital of Buffalo
Key inclusion & exclusion criteria

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 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 following:

- ALT

- AST

- LDH

- 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).



Age minimum: 2 Years
Age maximum: 16 Years
Gender: All
Health Condition(s) or Problem(s) studied
Primary Immune Deficiency Disease
Intervention(s)
Biological: Flebogamma 5% DIF
Primary Outcome(s)
Serious Bacterial Infections. [Time Frame: 12 months]
Secondary Outcome(s)
Days of School/Usual Activities Missed Per Year [Time Frame: 12 months]
Days of Hospitalization Per Year [Time Frame: 12 months]
Number of Infectious Episodes Per Year [Time Frame: 12 months]
Number of Visits to Physician/ER Room for Acute Problems [Time Frame: 12 months]
Other Infections Documented by Fever and Physical Exam or Positive Radiograph. [Time Frame: 12 months]
Number of Days on Antibiotics (Prophylactic and Therapeutic). [Time Frame: 12 months]
Number of Adverse Events [Time Frame: 12 months]
Secondary ID(s)
IG-0705
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 08/12/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00634569
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