SEVENFACT® Study for Hemophilia Bleeding Events is a research study for people 12 years and older with Hemophilia A or B, a condition where blood doesn't clot properly. This study focuses on those who have inhibitors, which are substances that make treating bleeding harder. The study aims to check the safety of SEVENFACT®, a treatment for bleeding episodes, whether participants are on long-term preventive treatment or not. Participants will be part of the study for up to 4 years.
- The study will include 28 to 55 participants and continue until September 30, 2026, unless 28 people join earlier.
- An interim analysis will be done after 20 people join to evaluate safety and other aspects.
- Participants must use a mobile app or paper diary to track bleeding events and medication.
To join, you must have Hemophilia A or B with inhibitors and be able to follow the study guidelines. You cannot join if you have other bleeding disorders, are allergic to rabbits, or are on unapproved treatments. The study ensures safety by checking for any negative effects of the treatment. Participants will be monitored closely for their health and treatment outcomes.