Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors
American Thrombosis and Hemostasis Network
Summary
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.
Description
Primary Objective: To evaluate the safety of SEVENFACT® when used to treat bleeding episodes in participants with Hemophilia A or B with inhibitors either with or without prophylactic treatment Study Design: Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A and B with inhibitors12 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. Study Duration: Participants will be…
Eligibility
- Age range
- 12–100 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- Drugcoagulation factor VIIa [recombinant]-jncw
a transgenically produced, activated, recombinant, human factor VII (rhFVIIa) protein with the brand name of SEVENFACT®. This protein is a clotting factor in the coagulation cascade that is produced in and purified from the milk of transgenic rabbits. SEVENFACT is approved for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.
Locations (21)
- Arizona Hemophilia and Thrombosis Center at Phoenix Children's HospitalPhoenix, Arizona
- Arkansas Center for Bleeding DisordersLittle Rock, Arkansas
- Orthopaedic Institute for ChildrenLos Angeles, California
- University of California at Davis UC Davis Hemostasis and Thrombosis CenterSacramento, California
- Children's National Hemophilia CenterWashington D.C., District of Columbia
- Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood DisordersOrlando, Florida