SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Launched by AMERICAN THROMBOSIS AND HEMOSTASIS NETWORK · Nov 23, 2020

Keywords

ClinConnect Summary

The clinical trial titled "SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors" is studying a medication called SEVENFACT® to see how well it works for people with Hemophilia A or B who have inhibitors, which are antibodies that can make treatment less effective. This study is open to individuals aged 12 and older who either regularly take preventive treatments but might still have bleeding episodes or those who are not on any preventive treatment and need help managing bleeding when it occurs. The trial is currently recruiting participants across the United States.

To be eligible for the study, participants must have a confirmed diagnosis of Hemophilia A or B with inhibitors and should be able to understand the study requirements. They will need to provide consent and document their bleeding events and medication use using a mobile app or paper diary. Participants can expect to be closely monitored throughout the study for safety, and if they need any urgent medical treatment, they will receive standard care as needed. This trial aims to gather valuable information about the safety and effectiveness of SEVENFACT® in helping manage bleeding events for these patients.

Gender

ALL

Eligibility criteria

• 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.