SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

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.

Conditions

Hemophilia A With Inhibitor, Hemophilia B With Inhibitor

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Study Overview

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Study Details

Study overview

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.

Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

Condition
Hemophilia A With Inhibitor
Intervention / Treatment

-

Contacts and Locations

Phoenix

Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Little Rock

Arkansas Center for Bleeding Disorders, Little Rock, Arkansas, United States, 72202

Los Angeles

Orthopaedic Institute for Children, Los Angeles, California, United States, 90007

Sacramento

University of California at Davis UC Davis Hemostasis and Thrombosis Center, Sacramento, California, United States, 95817

Washington

Children's National Hemophilia Center, Washington, District of Columbia, United States, 20010

Orlando

Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders, Orlando, Florida, United States, 32806

Atlanta

Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division, Atlanta, Georgia, United States, 31404

Savannah

Willett Children's Hospital at Memorial University Medical Center, Savannah, Georgia, United States, 31404

New Orleans

Louisiana Center for Bleeding and Clotting Disorders, Tulane, New Orleans, Louisiana, United States, 70112

Slidell

Louisiana Center for Advanced Medicine, Slidell, Louisiana, United States, 70461

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

12 Years to 100 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

American Thrombosis and Hemostasis Network,

Tammuella Chrisentery-Singleton, MD, PRINCIPAL_INVESTIGATOR, American Thrombosis and Hemostasis Network

Mark Reding, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2027-03-31