Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery



Status:Completed
Conditions:Anemia, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:5 - Any
Updated:10/25/2017
Start Date:February 2001
End Date:August 2004

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Recombinant Antihemophilic Factor (rAHF PFM) Manufactured and Formulated Without Added Human or Animal Proteins: Evaluation of Safety and Efficacy in Hemophilia A Patients Undergoing Surgical or Invasive Procedures

The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the
treatment of hemophilia A patients undergoing surgery.


Inclusion Criteria:

- Age >= 5 years

- The subject has severe or moderately severe hemophilia A defined by a baseline factor
VIII level <= 2% of normal documented at screening or historically (e.g., at
hemophilia diagnosis)

- Subjects may enroll regardless of their serologic status for human immunodeficiency
virus (HIV-1) and hepatitis C virus (HCV)

- The subject requires a surgical, dental or other invasive procedure--either elective
or emergency

- The subject has a history of at least 150 exposure days for all other factor VIII
products (as estimated by the study site investigator) prior to study entry

- The subject has a life expectancy of at least 28 days from the day of surgery

- The subject 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 BioScience

Exclusion Criteria:

- The subject has a detectable inhibitor to factor VIII in the local hemostasis
laboratory at the investigative site at the time of enrollment

- The subject has a history of inhibitor to factor VIII > 1.0 BU. Note: If the subject
has a history of an inhibitor titer > 1.0 BU at any time prior to enrollment but
demonstrated expected clinical responses to conventional doses of factor VIII therapy,
the subject may enroll

- The subject has known hypersensitivity to Recombinate

- The subject is currently participating in another investigational drug study, or has
participated in any clinical trial involving an investigational drug within 30 days of
study entry

- The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes
other than hemophilia A (e.g., late-stage chronic liver disease, immune
thrombocytopenic purpura, disseminated intravascular coagulation)

- The subject is identified by the investigator as being unable or unwilling to
cooperate with study procedures.
We found this trial at
10
sites
1405 Clifton Road
Atlanta, Georgia 30322
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75 Francis St
Boston, Massachusetts 02115
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Cincinnati, OH
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East Lansing, Michigan 48824
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Indianapolis, Indiana 46260
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Iowa City, IA
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Los Angeles, CA
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New York, NY
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Pittsburgh, Pennsylvania 15213
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Seattle, Washington 98104
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Seattle, WA
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