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Study 17 of 17 for search of: | "Agammaglobulinemia" |
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Sponsored by: |
Grifols Biologicals Inc. |
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Information provided by: | Grifols Biologicals Inc. |
ClinicalTrials.gov Identifier: | NCT00634569 |
This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
Condition | Intervention | Phase |
---|---|---|
Primary Immune Deficiency Diseases |
Biological: Flebogamma 5% DIF |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
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. |
Estimated Enrollment: | 30 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Biological: Flebogamma 5% DIF
Intravenous Immune Globulin (Human)
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Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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:
The subject is receiving the following medication:
Contact: Paul J. Pinciaro, PhD | 443-375-8825 | paul.pinciaro@grifols.com |
United States, Florida | |
University of South Florida | Not yet recruiting |
St. Petersburg, Florida, United States, 33701-4899 | |
Contact: Carla Duff, RN, BSN 727-767-8108 cduff@usf.edu | |
Principal Investigator: John W. Sleasman, MD | |
United States, Georgia | |
Family Allergy & Asthma Center, PC | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Steven D. Goodman 404-255-8000 ext 115 goodmans@familyallergycenter.com | |
Principal Investigator: Robyn J. Levy, MD | |
United States, Illinois | |
Rush University Medical Center | Not yet recruiting |
Chicago, Illinois, United States | |
Contact: Joseph Cox, RN 312-942-5423 joe_e_cox@rush.edu | |
Principal Investigator: James Moy, MD | |
United States, Indiana | |
The Allergy and Asthma Center | Recruiting |
Fort Wayne, Indiana, United States, 46804 | |
Contact: Kirstin Battershell, RN, BS 260-432-5005 kmartin@allergyasthmacenter.com | |
Principal Investigator: William Smits, MD | |
United States, New York | |
The Children's Hospital of Buffalo | Not yet recruiting |
Buffalo, New York, United States, 14222 | |
Contact: Kathryn Alessi 716-878-7162 kalessi@kaleidahealth.org | |
Principal Investigator: Mark Ballow, MD | |
United States, Ohio | |
Rainbow Babies and Children's Hospital | Not yet recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Pamela S. TeGrotenhuis, RN 216-844-7787 pamela.rosenblatt@uhhospitals.org | |
Principal Investigator: Michael Konstan, MD | |
United States, Pennsylvania | |
Pennsylvania State University, Milton S. Hershey Medical Center | Not yet recruiting |
Hershey, Pennsylvania, United States, 17033-0850 | |
Contact: Cathy Mende 717-531-4513 cmende@psu.edu | |
Principal Investigator: Timothy Craig, MD | |
United States, Texas | |
Allergy Immunology Research Center of North Texas | Recruiting |
Dallas, Texas, United States, 75230 | |
Contact: Staci Horvath 972-566-2723 shorvath_pdai@yahoo.com | |
Principal Investigator: Richard Wasserman, MD | |
United States, Washington | |
Children's Hospital and Regional Medial Center | Not yet recruiting |
Seattle, Washington, United States, 98195-7110 | |
Contact: Dawn Marie Pares 206-884-7418 | |
Principal Investigator: Hans D. Ochs, MD |
Principal Investigator: | Mark Ballow, MD | Children's Hospital of Buffalo |
Responsible Party: | Grifols Biologicals Inc. ( Paul J. Pinciaro, PhD/Director of Clinical Development and Pharmacovigilance ) |
Study ID Numbers: | IG-0705 |
Study First Received: | March 5, 2008 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00634569 |
Health Authority: | United States: Food and Drug Administration |
Common variable disease, x-linked agammaglobulinemia, hyper IgM syndrome, Wiskott-Aldrich Syndrome |
T cell immunodeficiency primary Agammaglobulinemia Hyper-IgM Immunodeficiency Syndrome, Type 1 Bruton type agammaglobulinemia Immunologic Deficiency Syndromes Antibodies Wiskott-Aldrich Syndrome Malnutrition Immunoglobulins, Intravenous |
Hyper IgM syndrome X-linked agammaglobulinemia Rho(D) Immune Globulin Hyperkinesis Nutrition Disorders Wiskott Aldrich syndrome Hyper-IgM Immunodeficiency Syndrome Immunoglobulins Deficiency Diseases |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |