Brief Title
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
Official Title
Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study
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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Condition
Hemophilia A
Intervention
Antihemophilic factor, recombinant, manufactured protein-free
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
November 2001
Completion Date
August 2004
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
Gender
Male
Ages
10 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Michael Tarantino, MD, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT00157053
Organization ID
060102
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Michael Tarantino, MD, Principal Investigator, Comprehensive Bleeding Disorder Center, Peoria, Illinois, USA
Verification Date
February 2011