Tests SEVENFACT for bleeding episodes in people with hemophilia and inhibitors
Tests SEVENFACT to control bleeding in people with hemophilia A or B and inhibitors.
Plain-language title generated from the registry record
Registry title: SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Key facts
- Where
- Atlanta, Boston, Cleveland, Detroit, Greenville, Houston, Kansas City, Lansing, Little Rock, Los Angeles, Minneapolis, Nashville, New Hyde Park, Oklahoma City, Orlando, Phoenix, Rochester, Sacramento, Savannah, and Washington D.C., United StatesSee the 21 sites
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 100 years old?
Source: NCT04647227, who can take part
Where in United States
- Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult DivisionAtlanta, United StatesTaking people
- Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment CenterBoston, United StatesTaking people
- University Hospitals Health System ClevelandCleveland, United StatesTaking people
- Children's Hospital of MichiganDetroit, United StatesTaking people
- Henry Ford Health SystemDetroit, United StatesTaking people
- Brody School of Medicine at East Carolina UniversityGreenville, United StatesNot yet recruiting
- Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @HoustonHouston, United StatesTaking people
- Kansas City Regional Hemophilia CenterKansas City, United StatesTaking people
- MSU Center for Bleeding and Clotting DisordersLansing, United StatesTaking people
- Arkansas Center for Bleeding DisordersLittle Rock, United StatesTaking people
- Orthopaedic Institute for ChildrenLos Angeles, United StatesTaking people
- Center for Bleeding and Clotting Disorders, University of MinnesotaMinneapolis, United StatesNot yet recruiting
- Vanderbilt University Medical CenterNashville, United StatesTaking people
- Northwell Health, Long Island JewishNew Hyde Park, United StatesTaking people
- Oklahoma Center for Bleeding and Clotting DisordersOklahoma City, United StatesTaking people
- Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood DisordersOrlando, United StatesNo longer taking part
- Arizona Hemophilia and Thrombosis Center at Phoenix Children's HospitalPhoenix, United StatesNo longer taking part
- Mayo Comprehensive Hemophilia CenterRochester, United StatesNo longer taking part
- University of California at Davis UC Davis Hemostasis and Thrombosis CenterSacramento, United StatesTaking people
- Willett Children's Hospital at Memorial University Medical CenterSavannah, United StatesTaking people
- Children's National Hemophilia CenterWashington D.C., United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- American Thrombosis and Hemostasis Network
- Trial code
- NCT04647227
- Record updated
- 12 January 2026
- Original description
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.Read full original descriptionShow less
Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors
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.
Inclusion: 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.
Exclusion: 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 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; 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.