SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
About this trial
This is an interventional treatment trial for Hemophilia A With Inhibitor focused on measuring Hemophilia A, Hemophilia B, bleeding event, prophylactic treatment
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of hemophilia A or B with inhibitors.
- Be 12 years of age and older
- 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
- Have read, understood, and documented written informed consent/assent
- Be able to provide medical evidence through prior medical history of previous inhibitor levels
- Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage
Exclusion Criteria:
- Have a disorder of hemostasis in addition to Hemophilia A or B
- Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
- Have a known allergy or hypersensitivity to rabbits or rabbit proteins
- Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
- Have had implantation of an investigational medical device within the prior 6 months
- Have received an investigational drug within 30 days of the baseline visit
- Have an elective surgical procedure planned during the duration of their participation in the study*
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- Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary.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 If the participant is not withdrawn from the study, the participant's participation in the study will be paused until the investigator feels it is safe for them to continue.
Sites / Locations
- Arizona Hemophilia and Thrombosis Center at Phoenix Children's HospitalRecruiting
- Arkansas Center for Bleeding DisordersRecruiting
- Orthopaedic Institute for ChildrenRecruiting
- Childrens Hospital Los Angeles
- University of California at Davis UC Davis Hemostasis and Thrombosis Center
- Children's National Hemophilia CenterRecruiting
- Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood DisordersRecruiting
- Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult DivisionRecruiting
- Willett Children's Hospital at Memorial University Medical CenterRecruiting
- Louisiana Center for Bleeding and Clotting Disorders, Tulane
- Louisiana Center for Advanced MedicineRecruiting
- Maine Hemophilia and Thrombosis Center
- Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment CenterRecruiting
- Children's Hospital of MichiganRecruiting
- Henry Ford Health SystemRecruiting
- MSU Center for Bleeding and Clotting DisordersRecruiting
- Center for Bleeding and Clotting Disorders, University of Minnesota
- Mayo Comprehensive Hemophilia CenterRecruiting
- Mississippi Center for Advanced MedicineRecruiting
- Kansas City Regional Hemophilia CenterRecruiting
- Northwell Health, Long Island JewishRecruiting
- Brody School of Medicine at East Carolina University
- University Hospitals Health System ClevelandRecruiting
- Oklahoma Center for Bleeding and Clotting Disorders
- Vanderbilt University Medical CenterRecruiting
- Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @HoustonRecruiting
Arms of the Study
Arm 1
Other
Hemophilia A and B Cases
SEVENFACT® has been approved for the treatment of bleeding events in individuals with hemophilia A or B with inhibitors. This study is intended to further investigate the safety and tolerability of SEVENFACT in participants with hemophilia A or B with inhibitors in the presence or absence of prophylactic therapies. Dosing will be at the discretion of the attending physician, and each participant will be supplied with the equivalent of nine 75 µg/kg doses, which aligns with the recommended dosing schedule as provided in SEVENFACT's United States Prescribing Information (USPI). In the event of a bleeding episode (BE), the participant will either self-administer the correct dose under the guidance of the treating investigator or the dose will be administered at a treatment facility.