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RECRUITING
NCT04647227
PHASE4

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Sponsor: American Thrombosis and Hemostasis Network

View on ClinicalTrials.gov

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

DRUG

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