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RECRUITINGPhase 4INTERVENTIONAL

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form/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 Who Should NOT Join This Trial: 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products or thromboembolic disease) - Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary.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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 Criteria: 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) * 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.

Treatments Being Tested

DRUG

coagulation 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 (20)

Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Center for Bleeding Disorders
Little Rock, Arkansas, United States
Orthopaedic Institute for Children
Los Angeles, California, United States
University of California at Davis UC Davis Hemostasis and Thrombosis Center
Sacramento, California, United States
Children's National Hemophilia Center
Washington D.C., District of Columbia, United States
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
Orlando, Florida, United States
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
Atlanta, Georgia, United States
Willett Children's Hospital at Memorial University Medical Center
Savannah, Georgia, United States
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
Boston, Massachusetts, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
MSU Center for Bleeding and Clotting Disorders
Lansing, Michigan, United States
Center for Bleeding and Clotting Disorders, University of Minnesota
Minneapolis, Minnesota, United States
Mayo Comprehensive Hemophilia Center
Rochester, Minnesota, United States
Kansas City Regional Hemophilia Center
Kansas City, Missouri, United States
Northwell Health, Long Island Jewish
New Hyde Park, New York, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
University Hospitals Health System Cleveland
Cleveland, Ohio, United States
Oklahoma Center for Bleeding and Clotting Disorders
Oklahoma City, Oklahoma, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States