Study of Pharmacokinetics, Efficacy and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients - A Continuation of Clinical Study 069901
- Conditions
- Hemophilia A
- Registration Number
- NCT00157053
- Lead Sponsor
- Baxalta now part of Shire
- Brief Summary
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, and Part 2 is an evaluation of efficacy and safety. The study is open to patients who completed Baxter Study 069901.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 82
- Subject has completed Baxter protocol 069901
- Subject is HIV-1 seronegative or, if HIV-1 seropositive, has a CD4+ lymphocyte count >= 400/mm3 documented within three months of the screening visit
- Subject (and his legally acceptable representative, in the case of study participants >= 10 and < 18 years of age) has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter
- The subject received factor VIII products other than rAHF-PFM upon completion of Baxter protocol 069901
- The subject developed an inhibitor to factor VIII, measured in the central laboratory, during Baxter protocol 069901. An inhibitor is defined as a Bethesda titer > 1.0 or, if Bethesda titer < 1.0, confirmation using the Nijmegen modification of the Bethesda assay with a titer > 0.6
- The subject is scheduled to receive an immunomodulating drug other than anti-retroviral chemotherapy (e.g., a-interferon, steroids) during the course of the study
- The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Terminal phase half-life for Recombinant Antihemophilic Factor (rAHF-PFM) Within 30 minutes prior to the pharmacokinetic infusion and at 1 hour ± 5 minutes, 9 ± 1 hour, 24 ± 2 hours, and 48 ± 2 hours after the infusion.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (24)
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Allgemeines Krankenhaus der Stadt Wien
🇦🇹Vienna, Austria
University of Alberta
🇨🇦Calgary, Alberta, Canada
KU Leuven Universitaire Ziekenhuizen
🇧🇪Leuven, Belgium
Klinikum der J. W. Goethe - Universität
🇩🇪Frankfurt am Main, Germany
Hôpital Edouard Herriot
🇫🇷Lyon, France
Central Manchester Healthcare NHS Trust
🇬🇧Manchester, England, United Kingdom
Indiana Hemophilia & Thrombosis Center
🇺🇸Indianapolis, Indiana, United States
The Churchill Hospital
🇬🇧Oxford, England, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Puget Sound Blood Center
🇺🇸Seattle, Washington, United States
The Royal Free Hospital
🇬🇧London, England, United Kingdom
Klinikum Innenstadt der Universität München
🇩🇪Munich, Germany
Ospedale Maggiore di Milano
🇮🇹Milan, Italy
Childrens Healthcare of Atlanta Blood Bank
🇺🇸Atlanta, Georgia, United States
University Hospital MAS
🇸🇪Malmö, Sweden
Michigan State University
🇺🇸East Lansing, Michigan, United States
Mountain States Regional Hemophilia and Thrombosis Center
🇺🇸Aurora, Colorado, United States
Comprehensive Bleeding Disorders Center
🇺🇸Peoria, Illinois, United States
Cornell Medical Center
🇺🇸New York, New York, United States
Children's Hospital Medical Center Pharmacy
🇺🇸Cincinnati, Ohio, United States
University of Medicine & Dentistry of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Mt. Sinai Medical School
🇺🇸New York, New York, United States
Hemophilia Center of Western Pennsylvania
🇺🇸Pittsburgh, Pennsylvania, United States