Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery
NCT ID: NCT00157105
Last Updated: 2021-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
59 participants
INTERVENTIONAL
2001-02-12
2004-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Antihemophilic factor, recombinant, manufactured protein-free
Eligibility Criteria
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Inclusion Criteria
* 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 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.
5 Years
MALE
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
Los Angeles, California, United States
Children´s Healthcare of Atlanta Blood Bank
Atlanta, Georgia, United States
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
Iowa City, Iowa, United States
Brigham and Women´s Hospital, Hematology Division
Boston, Massachusetts, United States
Michigan State University
East Lansing, Michigan, United States
Mt. Sinai Medical School, Hemophilia Comprehensive Care Center
New York, New York, United States
Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
Cincinnati, Ohio, United States
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, United States
Puget Sound Blood Center
Seattle, Washington, United States
Countries
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References
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Shapiro A, Gruppo R, Pabinger I, Collins PW, Hay CR, Schroth P, Casey K, Patrone L, Ehrlich H, Ewenstein BM. Integrated analysis of safety and efficacy of a plasma- and albumin-free recombinant factor VIII (rAHF-PFM) from six clinical studies in patients with hemophilia A. Expert Opin Biol Ther. 2009 Mar;9(3):273-83. doi: 10.1517/14712590902729392.
Other Identifiers
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069902
Identifier Type: -
Identifier Source: org_study_id
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