NCT04647227 · American Thrombosis and Hemostasis Network
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
What this study is about
Phase IV multi-center, US-centric, where both patients and doctors know the treatment given, 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Number of participants and percentage of Safety Events (AEs)
Time frame: From time of consent through BE onset until 3 days after last dose of SEVENFACT®.
Adverse Events and SAEs defined by the European Haemophilia Safety Surveillance System 2018 (EUHASS) and Serious Adverse Events (SAEs) as defined by the US Food and Drug Association.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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 i
Where
- Phoenix, Arizona
- Little Rock, Arkansas
- Los Angeles, California
- Sacramento, California
- Washington D.C., District of Columbia
- Orlando, Florida
- Atlanta, Georgia
- Savannah, Georgia
- Boston, Massachusetts
- Detroit, Michigan
- Lansing, Michigan
- Minneapolis, Minnesota
And 8 more locations — see the full list below.
Collaborators
LFB USA, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations