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SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Sponsor: American Thrombosis and Hemostasis Network
Summary
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors, 12 years of age and older, who are either on long term prophylactic treatment (e.g., emicizumab) at risk of experiencing a breakthrough bleeding event (BE), or who are not on prophylactic treatment who may need to control a BE.
Official title: Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors
Key Details
Gender
All
Age Range
12 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
55
Start Date
2021-06-28
Completion Date
2027-03-31
Last Updated
2026-01-12
Healthy Volunteers
No
Interventions
coagulation factor VIIa [recombinant]-jncw
a transgenically produced, activated, recombinant, human factor VII (rhFVIIa) protein with the brand name of SEVENFACT®. This protein is a clotting factor in the coagulation cascade that is produced in and purified from the milk of transgenic rabbits. SEVENFACT is approved for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.
Locations (21)
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Center for Bleeding Disorders
Little Rock, Arkansas, United States
Orthopaedic Institute for Children
Los Angeles, California, United States
University of California at Davis UC Davis Hemostasis and Thrombosis Center
Sacramento, California, United States
Children's National Hemophilia Center
Washington D.C., District of Columbia, United States
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
Orlando, Florida, United States
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
Atlanta, Georgia, United States
Willett Children's Hospital at Memorial University Medical Center
Savannah, Georgia, United States
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
MSU Center for Bleeding and Clotting Disorders
Lansing, Michigan, United States
Center for Bleeding and Clotting Disorders, University of Minnesota
Minneapolis, Minnesota, United States
Mayo Comprehensive Hemophilia Center
Rochester, Minnesota, United States
Kansas City Regional Hemophilia Center
Kansas City, Missouri, United States
Northwell Health, Long Island Jewish
New Hyde Park, New York, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
University Hospitals Health System Cleveland
Cleveland, Ohio, United States
Oklahoma Center for Bleeding and Clotting Disorders
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston
Houston, Texas, United States