Actively Recruiting
Safety of SEVENFACT® for Treating Bleeding Events in Patients With Hemophilia A or B With Inhibitors
Led by American Thrombosis and Hemostasis Network · Updated on 2026-01-12
55
Participants Needed
21
Research Sites
26 weeks
Total Duration
On this page
Sponsors
A
American Thrombosis and Hemostasis Network
Lead Sponsor
L
LFB USA, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety of SEVENFACT®, a recombinant clotting factor, for treating bleeding episodes in people with Hemophilia A or B who have developed inhibitors. This Phase IV, open-label, multi-center study focuses on participants aged 12 years and older in the US. It includes those on long-term prophylactic treatments and those who are not, aiming to better understand SEVENFACT's safety in real-world use. Participants will receive SEVENFACT® doses guided by their physician during bleeding events. Each participant will be supplied with nine doses of 75 µg/kg each, aligning with the recommended dosing schedule. Dosing can be self-administered under medical guidance or given at a treatment facility. The study will continue for up to approximately four years, following participants from enrollment onward. During the study, participants will document bleeding events and medication use through a mobile app or paper diary. Researchers will monitor adverse events, including allergic reactions, and collect safety data from consent through three days after the last dose. The main measure is the number and percentage of safety events related to SEVENFACT®. Participants may have regular assessments and follow-ups throughout the study duration to ensure thorough safety evaluation.
CONDITIONS
Brief Title
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Hemophilia A or B with inhibitors
- Age 12 years or older
- Able to understand and comply with the study protocol or have a legal guardian who can
- Signed and understood informed consent/assent
- Able to provide medical evidence of previous inhibitor levels
- Willing and able to use the ATHN mobile app or paper diary to record bleeding events and medication use
You will not qualify if you...
- Additional bleeding disorders besides Hemophilia A or B
- Known intolerance or allergy to SEVENFACT® or its ingredients
- Allergy or hypersensitivity to rabbits or rabbit proteins
- Receiving prophylactic treatment with a drug or biologic not FDA-approved for this use
- Implantation of an investigational medical device within the last 6 months
- Received an investigational drug within 30 days before baseline visit
- Planned elective surgery during study participation
- Life-threatening disease or other conditions that may pose hazard or interfere with the study (including history of non-responsiveness to bypassing products or thromboembolic disease)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 4 years from enrollment
Participants receive SEVENFACT® to treat bleeding episodes. Dosing is administered either by the participant or at a treatment facility during bleeding events.
Visits occur as needed during bleeding episodes for treatment and monitoring
Duration - Up to 3 days after last dose of SEVENFACT® per bleeding episode
Participants are monitored for safety events including adverse events and treatment-emergent adverse events during and up to 3 days after the last dose of SEVENFACT®.
Monitoring visits as needed following treatment of bleeding episodes
Trial Site Locations
Total: 21 locations
1
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Completed
2
Arkansas Center for Bleeding Disorders
Little Rock, Arkansas, United States, 72202
Actively Recruiting
3
Orthopaedic Institute for Children
Los Angeles, California, United States, 90007
Actively Recruiting
4
University of California at Davis UC Davis Hemostasis and Thrombosis Center
Sacramento, California, United States, 95817
Actively Recruiting
5
Children's National Hemophilia Center
Washington D.C., District of Columbia, United States, 20010
Completed
6
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
Orlando, Florida, United States, 32806
Completed
7
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
Atlanta, Georgia, United States, 31404
Actively Recruiting
8
Willett Children's Hospital at Memorial University Medical Center
Savannah, Georgia, United States, 31404
Actively Recruiting
9
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
10
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
11
Henry Ford Health System
Detroit, Michigan, United States, 48202
Actively Recruiting
12
MSU Center for Bleeding and Clotting Disorders
Lansing, Michigan, United States, 48912
Actively Recruiting
13
Center for Bleeding and Clotting Disorders, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
14
Mayo Comprehensive Hemophilia Center
Rochester, Minnesota, United States, 55905
Completed
15
Kansas City Regional Hemophilia Center
Kansas City, Missouri, United States, 64108
Actively Recruiting
16
Northwell Health, Long Island Jewish
New Hyde Park, New York, United States, 11040
Actively Recruiting
17
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834
Not Yet Recruiting
18
University Hospitals Health System Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
19
Oklahoma Center for Bleeding and Clotting Disorders
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
20
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
Actively Recruiting
21
Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Carol Fedor, ND, RN, CCRC
J
Jessica Callis
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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