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SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

RecruitingPhase 4Ages 12 Years - 100 YearsAllAmerican Thrombosis and Hemostasis Network
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Have a diagnosis of hemophilia A or B with inhibitors. 2. Be 12 years of age and older 3. 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 4. Have read, understood, and documented written informed consent/assent 5. Be able to provide medical evidence through prior medical history of previous inhibitor levels 6. Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage Exclusion Criteria: 1. Have a disorder of hemostasis in addition to Hemophilia A or B 2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients 3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins 4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA 5. Have had implantation of an investigational medical device within the prior 6 months 6. Have received an investigational drug within 30 days of the baseline visit 7. Have an elective surgical procedure planned during the duration of their participation in the study\* 8. 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products or thromboembolic disease) * Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary.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.
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What it tests

  • coagulation factor VIIa [recombinant]-jncw
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Where

21 sites
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, United States
Arkansas Center for Bleeding Disorders
Little Rock, United States
Orthopaedic Institute for Children
Los Angeles, United States
University of California at Davis UC Davis Hemostasis and Thrombosis Center
Sacramento, United States
Children's National Hemophilia Center
Washington D.C., United States
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
Orlando, United States
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
Atlanta, United States
Willett Children's Hospital at Memorial University Medical Center
Savannah, United States

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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