Status:
COMPLETED
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
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
MALE
10+ 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 subjects. The study consists of 2 parts: Part 1 is a pharmacokinetic and safety study, ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 22 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2004
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00157053
Start Date
November 22 2001
End Date
August 3 2004
Last Update
August 24 2021
Active Locations (24)
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1
Mountain States Regional Hemophilia and Thrombosis Center
Aurora, Colorado, United States, 80045
2
Childrens Healthcare of Atlanta Blood Bank
Atlanta, Georgia, United States, 30322
3
Comprehensive Bleeding Disorders Center
Peoria, Illinois, United States, 61614
4
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States, 46260