Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors
Who is this study for? Pediatric patients over age 12 years and adults with hemophilia
What treatments are being studied? Coagulation factor VIIa [recombinant]-jncw
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 100
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Center for Bleeding Disorders
RECRUITING
Little Rock
Arizona
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
COMPLETED
Phoenix
California
Orthopaedic Institute for Children
RECRUITING
Los Angeles
University of California at Davis UC Davis Hemostasis and Thrombosis Center
RECRUITING
Sacramento
Washington, D.c.
Children's National Hemophilia Center
RECRUITING
Washington D.c.
Florida
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
COMPLETED
Orlando
Georgia
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
RECRUITING
Atlanta
Willett Children's Hospital at Memorial University Medical Center
RECRUITING
Savannah
Louisiana
Louisiana Center for Bleeding and Clotting Disorders, Tulane
WITHDRAWN
New Orleans
Massachusetts
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
RECRUITING
Boston
Michigan
Children's Hospital of Michigan
RECRUITING
Detroit
Henry Ford Health System
RECRUITING
Detroit
MSU Center for Bleeding and Clotting Disorders
RECRUITING
Lansing
Minnesota
Center for Bleeding and Clotting Disorders, University of Minnesota
NOT_YET_RECRUITING
Minneapolis
Mayo Comprehensive Hemophilia Center
RECRUITING
Rochester
Missouri
Kansas City Regional Hemophilia Center
RECRUITING
Kansas City
North Carolina
Brody School of Medicine at East Carolina University
NOT_YET_RECRUITING
Greenville
New York
Northwell Health, Long Island Jewish
RECRUITING
New Hyde Park
Ohio
University Hospitals Health System Cleveland
RECRUITING
Cleveland
Oklahoma
Oklahoma Center for Bleeding and Clotting Disorders
RECRUITING
Oklahoma City
Tennessee
Vanderbilt University Medical Center
RECRUITING
Nashville
Texas
Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston
RECRUITING
Houston
Contact Information
Primary
Carol Fedor, ND, RN, CCRC
cfedor@athn.org
(800)-360-2846
Backup
Jessica Callis
jcallis@athn.org
800-360-2846
Time Frame
Start Date: 2021-06-28
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 55
Treatments
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.
Authors
Roshni Kulkarni, Spencer Sullivan, Christine Knoll, Leslie Soto, Evangeline Brown, Tammuella Chrisentery-Singleton, Shirley Abraham, Amit Soni, Adam Giermasz, Amina Rafique, Shannon Carpenter, Shannon Meeks, Carolyn Bennett, Glaivy Batsuli, Michael Recht, Doris Quon, Robert Sidonio, Joanna Davis, Sanjay Ahuja
Related Therapeutic Areas
Sponsors
Leads: American Thrombosis and Hemostasis Network
Collaborators: LFB USA, Inc.