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

Completed · Phase 2/Phase 3

Conditions studied: Hemophilia A

In brief

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

Key facts

Study ID

NCT00157105

Run by

Baxalta now part of Shire

People needed

59

Starts

2001-02-12

Expected to finish

2004-08-03

Last updated by the study team

2021-08-24

Who can join

Age: 5 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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