SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Overview

About this study

The purpose of this study is to evaluate the safety of SEVENFACT® when used to treat bleeding events in participants with Hemophilia A or B with inhibitors either with or without prophylactic treatment.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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withdrawn from the study unless the investigator deems it necessary.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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rajiv Pruthi, M.B.B.S.

Open for enrollment

Contact information:

Rajiv Pruthi M.B.B.S.

(507) 284-5096

pruthi.rajiv@mayo.edu

More information

Publications

Publications are currently not available