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

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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.


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
New Brunswick, New Jersey 08901
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New York, New York 10021
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1405 Clifton Road
Atlanta, Georgia 30322
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Atlanta, GA
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Aurora, CO
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3333 Burnet Avenue
Cincinnati, Ohio 45229
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Cincinnati, OH
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East Lansing, Michigan 48824
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East Lansing, MI
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Indianapolis, Indiana 46260
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Indianapolis, IN
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New York, New York 10029
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New York, NY
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4727 North Sheridan Road
Peoria, Illinois 61614
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Peoria, IL
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Seattle, Washington 98104
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Seattle, WA
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18-20 Währinger Gürtel
Vienna, 1090
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Vienna,
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