Clinical Trials

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withdrawn from the study unless the investigator deems it necessary.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 If the participant is not withdrawn from the study, the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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/21/22. Questions regarding updates should be directed to the study team contact.