Actively Recruiting
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Led by American Thrombosis and Hemostasis Network · Updated on 2026-01-12
55
Participants Needed
21
Research Sites
300 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
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.
CONDITIONS
Official Title
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 protocol or have a legal guardian who can comply.
- Have provided written informed consent or assent.
- Have medical evidence of previous inhibitor levels from prior medical history.
- Be willing and able to use the ATHN mobile application or a paper diary to document bleeding events and medication use.
You will not qualify if you...
- Have a bleeding disorder other than Hemophilia A or B.
- Have known or suspected intolerance or allergy to SEVENFACT4 or its ingredients.
- Have a known allergy or sensitivity to rabbits or rabbit proteins.
- Are receiving prophylactic treatment for bleeding with a drug or biologic not approved by the FDA for this use.
- Have had an investigational medical device implanted within the last 6 months.
- Have received an investigational drug within 30 days before the baseline visit.
- Have planned elective surgery during the study participation period.
- Have any life-threatening disease or other condition that may pose a hazard or interfere with study participation or results, such as non-responsiveness to bypassing products or thromboembolic disease.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
J
Jessica Callis
CONTACT
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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