Status:
COMPLETED
Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
MALE
5+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A patients undergoing surgery.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 12 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2004
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00157105
Start Date
February 12 2001
End Date
August 3 2004
Last Update
August 24 2021
Active Locations (10)
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1
Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
Los Angeles, California, United States, 90027
2
Children´s Healthcare of Atlanta Blood Bank
Atlanta, Georgia, United States, 30322
3
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260
4
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
Iowa City, Iowa, United States, 52242