ATHN 16: Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients with Hemophilia A or B with Inhibitors
SEVENFACT® has been approved for the treatment of bleeding events in individuals with hemophilia A or B with inhibitors. This study, ATHN 16: SEVENFACT® for Bleeding Events in Hemophilia with Inhibitors, aims to evaluate the safety of SEVENFACT when used to treat bleeding episodes in participants with hemophilia A or B with inhibitors who are being treated either with or without prophylactic agents.
ATHN 16 is a phase IV multi-center, US-centric, open-label, safety study enrolling participants with hemophilia A or B with inhibitors aged 12 to 65 years. Participants will be monitored for safety from the time of consent through the end of their participation in the study. Participants will be provided with the equivalent of nine 75 µg/kg doses of SEVENFACT®, which will be administered at the time of a bleeding event (BE).
Safety will be measured according to medical events in the European Haemophilia Safety Surveillance (EUHASS) protocol, which includes:
- Allergic or other acute events
- Treatment-emergent side effects of therapy
- Transfusion transmitted infections
- Inhibitor development
- Cardiovascular events
- Neurological events
In addition to the EUHASS endpoints, pregnancy will be collected as an adverse event of special interest (AESI).
An adverse event is considered “serious” if in the view of either the investigator or sponsor, it results in any of the following outcomes:
- Life-threatening event
- Inpatient hospitalization or prolongation of an existing hospitalization
- Disability or permanent damage
- Congenital anomaly/birth defect
- Other serious, important medical events