RECRUITING

SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

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Conditions

Hemophilia A With InhibitorHemophilia B With InhibitorHemophilia AHemophilia Bbleeding eventprophylactic treatment

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-06-28
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04647227

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.

Ages Eligible for Study:12 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Have a diagnosis of hemophilia A or B with inhibitors.
  2. 2. Be 12 years of age and older
  3. 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. 4. Have read, understood, and documented written informed consent/assent
  5. 5. Be able to provide medical evidence through prior medical history of previous inhibitor levels
  6. 6. Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage
  1. 1. Have a disorder of hemostasis in addition to Hemophilia A or B
  2. 2. Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
  3. 3. Have a known allergy or hypersensitivity to rabbits or rabbit proteins
  4. 4. Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
  5. 5. Have had implantation of an investigational medical device within the prior 6 months
  6. 6. Have received an investigational drug within 30 days of the baseline visit
  7. 7. Have an elective surgical procedure planned during the duration of their participation in the study\*
  8. 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)
  9. * 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.

Contacts and Locations

Study Contact

Carol Fedor, ND, RN, CCRC
CONTACT
(800)-360-2846
cfedor@athn.org
Jessica Callis
CONTACT
800-360-2846
jcallis@athn.org

Principal Investigator

Tammuella Chrisentery-Singleton, MD
PRINCIPAL_INVESTIGATOR
American Thrombosis and Hemostasis Network
Mark Reding, MD
PRINCIPAL_INVESTIGATOR
University of Minnesota

Study Locations (Sites)

Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Arkansas Center for Bleeding Disorders
Little Rock, Arkansas, 72202
United States
Orthopaedic Institute for Children
Los Angeles, California, 90007
United States
University of California at Davis UC Davis Hemostasis and Thrombosis Center
Sacramento, California, 95817
United States
Children's National Hemophilia Center
Washington, District of Columbia, 20010
United States
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
Orlando, Florida, 32806
United States
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
Atlanta, Georgia, 31404
United States
Willett Children's Hospital at Memorial University Medical Center
Savannah, Georgia, 31404
United States
Louisiana Center for Bleeding and Clotting Disorders, Tulane
New Orleans, Louisiana, 70112
United States
Louisiana Center for Advanced Medicine
Slidell, Louisiana, 70461
United States
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
Boston, Massachusetts, 02114
United States
Children's Hospital of Michigan
Detroit, Michigan, 48201
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
MSU Center for Bleeding and Clotting Disorders
Lansing, Michigan, 48912
United States
Center for Bleeding and Clotting Disorders, University of Minnesota
Minneapolis, Minnesota, 55455
United States
Mayo Comprehensive Hemophilia Center
Rochester, Minnesota, 55905
United States
Mississippi Center for Advanced Medicine
Madison, Mississippi, 39110
United States
Kansas City Regional Hemophilia Center
Kansas City, Missouri, 64108
United States
Northwell Health, Long Island Jewish
New Hyde Park, New York, 11040
United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
United States
University Hospitals Health System Cleveland
Cleveland, Ohio, 44106
United States
Oklahoma Center for Bleeding and Clotting Disorders
Oklahoma City, Oklahoma, 73104
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
United States
Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-06-28
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2021-06-28
Study Completion Date2027-03-31

Terms related to this study

Keywords Provided by Researchers

  • Hemophilia A
  • Hemophilia B
  • bleeding event
  • prophylactic treatment

Additional Relevant MeSH Terms

  • Hemophilia A With Inhibitor
  • Hemophilia B With Inhibitor