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.

Condition	Intervention	Phase
Hemophilia A	Drug: Antihemophilic factor, recombinant, manufactured protein-free	Phase II Phase III

Further Study Details: 

Ages Eligible for Study:  10 Years and above,  Genders Eligible for Study:  Male

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

Illinois
      Comprehensive Bleeding Disorders Center, Peoria,  Illinois,  61614,  United States

Study chairs or principal investigators

Michael Tarantino, MD,  Principal Investigator,  Comprehensive Bleeding Disorder Center, Peoria, Illinois, USA   

Study ID Numbers:  060102
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00157053
Health Authority: United States: Food and Drug Administration; Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13