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
Status: | Completed |
---|---|
Conditions: | Anemia, Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 10 - Any |
Updated: | 10/25/2017 |
Start Date: | November 2001 |
End Date: | August 2004 |
Evaluation of Pharmacokinetics, Safety, Efficacy and Immunogenicity of rAHF-PFM in Previously Treated Hemophilia A Patients - A Continuation Study
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.
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.
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
We found this trial at
12
sites
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