SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Recruiting now · Phase 4

Conditions studied: Hemophilia A With Inhibitor, Hemophilia B With Inhibitor

In brief

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.

Key facts

Study ID: NCT04647227
Run by: American Thrombosis and Hemostasis Network
People needed: 55
Starts: 2021-06-28
Expected to finish: 2027-03-31
Last updated by the study team: 2026-01-12

Who can join

Age: 12 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Have a diagnosis of hemophilia A or B with inhibitors.
Be 12 years of age and older
Be capable of understanding and willing to comply with the conditions of the protocol or have a legal guardian who is capable of understanding and complying with the conditions of the protocol
Have read, understood, and documented written informed consent/assent
Be able to provide medical evidence through prior medical history of previous inhibitor levels
Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage

You may not qualify if…

Have a disorder of hemostasis in addition to Hemophilia A or B
Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
Have a known allergy or hypersensitivity to rabbits or rabbit proteins
Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
Have had implantation of an investigational medical device within the prior 6 months
Have received an investigational drug within 30 days of the baseline visit
Have an elective surgical procedure planned during the duration of their participation in the study*
Have any life-threatening disease, or other disease or condition which, in the investigator's judgment, could pose a potential hazard to the patient or interfere with study participation or study outcome (e.g., a history of non responsiveness to bypassing products or thromboembolic disease)
Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary. Instead, the participant will receive standard of care treatment as determined by the attending physician. If the participant is not withdrawn from the study, the participant's participation in the study will be paused until the investigator feels it is safe for them to continue.

Where it is running

Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston — Houston, Texas, United States (enrolling)
Arkansas Center for Bleeding Disorders — Little Rock, Arkansas, United States (enrolling)
Orthopaedic Institute for Children — Los Angeles, California, United States (enrolling)
University of California at Davis UC Davis Hemostasis and Thrombosis Center — Sacramento, California, United States (enrolling)
MSU Center for Bleeding and Clotting Disorders — Lansing, Michigan, United States (enrolling)
Kansas City Regional Hemophilia Center — Kansas City, Missouri, United States (enrolling)
Northwell Health, Long Island Jewish — New Hyde Park, New York, United States (enrolling)
University Hospitals Health System Cleveland — Cleveland, Ohio, United States (enrolling)
Oklahoma Center for Bleeding and Clotting Disorders — Oklahoma City, Oklahoma, United States (enrolling)
Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division — Atlanta, Georgia, United States (enrolling)
Willett Children's Hospital at Memorial University Medical Center — Savannah, Georgia, United States (enrolling)
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center — Boston, Massachusetts, United States (enrolling)
Children's Hospital of Michigan — Detroit, Michigan, United States (enrolling)
Henry Ford Health System — Detroit, Michigan, United States (enrolling)
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
Brody School of Medicine at East Carolina University — Greenville, North Carolina, United States
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital — Phoenix, Arizona, United States
Center for Bleeding and Clotting Disorders, University of Minnesota — Minneapolis, Minnesota, United States
Mayo Comprehensive Hemophilia Center — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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