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Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects

Information source: Grifols Biologicals Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Immunodeficiency Disease

Intervention: Flebogamma 5% DIF (Biological)

Phase: Phase 4

Status: Recruiting

Sponsored by: Grifols Biologicals Inc.

Official(s) and/or principal investigator(s):
Mark Ballow, MD, Principal Investigator, Affiliation: Children's Hospital of Buffalo

Overall contact:
Paul J. Pinciaro, PhD, Phone: 410-814-7617, Email: paul.pinciaro@grifols.com

Summary

This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.

Clinical Details

Official 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.

Study design: Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of serious bacterial infections.

Secondary outcome:

Days of school/usual activities missed per year

Days of hospitalization per year

Number of visits to physician/ER room for acute problems

Other infections documented by fever and physical exam or positive radiograph.

Number of infectious episodes per year

Number of days on antibiotics (prophylactic and therapeutic).

Number and percent of Adverse Events

Eligibility

Minimum age: 2 Years. Maximum age: 16 Years. Gender(s): Both.

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).

Locations and Contacts

Paul J. Pinciaro, PhD, Phone: 410-814-7617, Email: paul.pinciaro@grifols.com

University of South Florida, St. Petersburg, Florida 33701-4899, United States; Not yet recruiting
Carla Duff, RN, BSN, Phone: 727-767-8108, Email: cduff@usf.edu
John W. Sleasman, MD, Principal Investigator

Family Allergy & Asthma Center, PC, Atlanta, Georgia 30342, United States; Recruiting
Steven D. Goodman, Phone: 404-255-8000, Ext: 115, Email: goodmans@familyallergycenter.com
Robyn J. Levy, MD, Principal Investigator

Rush University Medical Center, Chicago, Illinois, United States; Not yet recruiting
Joseph Cox, RN, Phone: 312-942-5423, Email: joe_e_cox@rush.edu
James Moy, MD, Principal Investigator

The Allergy and Asthma Center, Fort Wayne, Indiana 46804, United States; Recruiting
Kirstin Battershell, RN, BS, Phone: 260-432-5005, Email: kmartin@allergyasthmacenter.com
William Smits, MD, Principal Investigator

The Children's Hospital of Buffalo, Buffalo, New York 14222, United States; Not yet recruiting
Kathryn Alessi, Phone: 716-878-7162, Email: kalessi@kaleidahealth.org
Mark Ballow, MD, Principal Investigator

Pennsylvania State University, Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033-0850, United States; Not yet recruiting
Cathy Mende, Phone: 717-531-4513, Email: cmende@psu.edu
Timothy Craig, MD, Principal Investigator

Allergy Immunology Research Center of North Texas, Dallas, Texas 75230, United States; Recruiting
Staci Horvath, Phone: 972-566-2723, Email: shorvath_pdai@yahoo.com
Richard Wasserman, MD, Principal Investigator

Children's Hospital and Regional Medial Center, Seattle, Washington 98195-7110, United States; Not yet recruiting
Dawn Marie Pares, Phone: 206-884-7418
Hans D. Ochs, MD, Principal Investigator

Additional Information

Starting date: May 2008
Last updated: April 26, 2010

Page last updated: October 04, 2010

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