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Sponsored by: |
Baxter Healthcare Corporation |
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00157040 |
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts. Part 1 of the study is a pharmacokinetic evaluation, and Part 2 is an evaluation of efficacy and safety.
Condition | Intervention | Phase |
Hemophilia A |
Drug: Antihemophilic factor, recombinant, manufactured protein-free |
Phase II Phase III |
Genetics Home Reference related topics: | hemophilia |
MedlinePlus related topics: | Hemophilia |
ChemIDplus related topics: | Factor VIII Octocog alfa |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Recombinant Antihemophilic Factor (rAHF-PFM) Manufactured and Formulated Without Added Human or Animal Proteins: Evaluation of Pharmacokinetics, Immunogenicity, Efficacy and Safety in Previously Treated Pediatric Patients With Hemophilia A |
Ages Eligible for Study: | up to 6 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Subject has any one of the following laboratory abnormalities at the time of screening:
United States, California | |||||
Children´s Hospital Los Angeles | |||||
Los Angeles, California, United States, 90027 | |||||
United States, Georgia | |||||
Emory University, Department of Pediatrics | |||||
Atlanta, Georgia, United States, 30322 | |||||
United States, Illinois | |||||
Comprehensive Bleeding Disorders Center | |||||
Peoria, Illinois, United States, 61614 | |||||
Children´s Memorial Hospital | |||||
Chicago, Illinois, United States, 60614 | |||||
United States, Indiana | |||||
Indiana Hemophilia and Thrombosis Center | |||||
Indianapolis, Indiana, United States, 46260 | |||||
United States, Iowa | |||||
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics | |||||
Iowa City, Iowa, United States, 52242 | |||||
United States, Michigan | |||||
Children´s Hospital of Michigan | |||||
Detroit, Michigan, United States, 48201 | |||||
University of Michigan Hemophilia Treatment Center | |||||
Ann Arbor, Michigan, United States, 48109 | |||||
United States, Pennsylvania | |||||
Children´s Hospital of Philadelphia | |||||
Philadelphia, Pennsylvania, United States, 19104 | |||||
United States, Texas | |||||
University of Texas Health Science Center | |||||
Houston, Texas, United States, 77030 | |||||
Canada, Ontario | |||||
Hospital for Sick Children, Division of Hematology/Oncology | |||||
Toronto, Ontario, Canada, M5G 1X8 | |||||
Puerto Rico | |||||
University Pediatric Hospital | |||||
San Juan, Puerto Rico, 00927 |
Baxter Healthcare Corporation |
Principal Investigator: | Victor Blanchette, MD | Hospital for Sick Children, Division of Hematology/Oncology, Toronto, Canada |
Study ID Numbers: | 060101 |
First Received: | September 8, 2005 |
Last Updated: | November 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00157040 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Italy: Ministry of Health; Netherlands: Medicines Evaluation Board (MEB); Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
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