Using SEVENFACT® to treat bleeding in hemophilia patients with inhibitors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase IV, multi-center, open-label safety study evaluating the use of SEVENFACT® in treating bleeding episodes in patients aged 12 and older with Hemophilia A or B who have inhibitors. Participants may be on long-term prophylactic treatment or not, and the study aims to assess the safety of SEVENFACT® in controlling breakthrough bleeding events. The study will follow participants longitudinally for up to four years, with a target enrollment of 28 to 55 participants across multiple sites in the U.S.

Why it matters

Who can join: the full rules

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   * Should a participant require an unplanned surgery, the participant will not be withdrawn from the study unless the investigator deems it necessary.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.

Where it's running

• Arkansas Center for Bleeding Disorders
  Little Rock, Arkansas, United States Recruiting
• Orthopaedic Institute for Children
  Los Angeles, California, United States Recruiting
• University of California at Davis UC Davis Hemostasis and Thrombosis Center
  Sacramento, California, United States Recruiting
• Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
  Atlanta, Georgia, United States Recruiting
• Willett Children's Hospital at Memorial University Medical Center
  Savannah, Georgia, United States Recruiting
• Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Tammuella Chrisentery-Singleton, MD — American Thrombosis and Hemostasis Network
• Study coordinator: Carol Fedor, ND, RN, CCRC
• Email: cfedor@athn.org
• Phone: (800)-360-2846

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.