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
Completed · Phase 2/Phase 3
Conditions studied: Hemophilia A
In brief
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.
Key facts
- Study ID
- NCT00157053
- Run by
- Baxalta now part of Shire
- People needed
- 82
- Starts
- 2001-11-22
- Expected to finish
- 2004-08-03
- Last updated by the study team
- 2021-08-24
Who can join
Age: 10 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mountain States Regional Hemophilia and Thrombosis Center — Aurora, Colorado, United States
- Childrens Healthcare of Atlanta Blood Bank — Atlanta, Georgia, United States
- Comprehensive Bleeding Disorders Center — Peoria, Illinois, United States
- Indiana Hemophilia & Thrombosis Center — Indianapolis, Indiana, United States
- Michigan State University — East Lansing, Michigan, United States
- University of Medicine & Dentistry of New Jersey — New Brunswick, New Jersey, United States
- Cornell Medical Center — New York, New York, United States
- Mt. Sinai Medical School — New York, New York, United States
- Children's Hospital Medical Center Pharmacy — Cincinnati, Ohio, United States
- Hemophilia Center of Western Pennsylvania — Pittsburgh, Pennsylvania, United States
- Puget Sound Blood Center — Seattle, Washington, United States
- Allgemeines Krankenhaus der Stadt Wien — Vienna, Austria
- KU Leuven Universitaire Ziekenhuizen — Leuven, Belgium
- University of Alberta — Calgary, Alberta, Canada
- Hôpital Edouard Herriot — Lyon, France
- Klinikum der J. W. Goethe - Universität — Frankfurt am Main, Germany
- Medizinische Hochschule Hannover — Hanover, Germany
- Klinikum Innenstadt der Universität München — Munich, Germany
- Ospedale Maggiore di Milano — Milan, Italy
- University Hospital MAS — Malmö, Sweden
- The Royal Free Hospital — London, England, United Kingdom
- Central Manchester Healthcare NHS Trust — Manchester, England, United Kingdom
- The Churchill Hospital — Oxford, England, United Kingdom
- University Hospital of Wales — Cardiff, Wales, United Kingdom
Full record on ClinicalTrials.gov
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