RecruitingHemophilia A With InhibitorHemophilia B With Inhibitor

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Eligible age

12–100 yrs

Accepts

All genders

Locations

16 states

Healthy volunteers

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About this study

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.

Sponsor: American Thrombosis and Hemostasis Network

You may qualify if…

✓ 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

You may not qualify if…

✕ 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)