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
Hemophilia A
About this trial
This is an interventional treatment trial for Hemophilia A focused on measuring Factor VIII Deficiency
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Mountain States Regional Hemophilia and Thrombosis Center
- Childrens Healthcare of Atlanta Blood Bank
- Comprehensive Bleeding Disorders Center
- Indiana Hemophilia & Thrombosis Center
- Michigan State University
- University of Medicine & Dentistry of New Jersey
- Cornell Medical Center
- Mt. Sinai Medical School
- Children's Hospital Medical Center Pharmacy
- Hemophilia Center of Western Pennsylvania
- Puget Sound Blood Center
- Allgemeines Krankenhaus der Stadt Wien
- KU Leuven Universitaire Ziekenhuizen
- University of Alberta
- Hôpital Edouard Herriot
- Klinikum der J. W. Goethe - Universität
- Medizinische Hochschule Hannover
- Klinikum Innenstadt der Universität München
- Ospedale Maggiore di Milano
- University Hospital MAS
- The Royal Free Hospital
- Central Manchester Healthcare NHS Trust
- The Churchill Hospital
- University Hospital of Wales