Recruiting

SEVENFACT®

Sponsor:

American Thrombosis and Hemostasis Network

Code:

NCT04647227

Conditions

Hemophilia A With Inhibitor

Hemophilia B With Inhibitor

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

coagulation factor VIIa [recombinant]-jncw

Study Details

Brief summary:

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

Study ID

NCT04647227

Start date

Jun 28, 2021

Status verified date

Jan, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Hemophilia A and B Cases

SEVENFACT® has been approved for the treatment of bleeding events in individuals with hemophilia A or B with inhibitors. This study is intended to further investigate the safety and tolerability of SEVENFACT in participants with hemophilia A or B with inhibitors in the presence or absence of prophylactic therapies. Dosing will be at the discretion of the attending physician, and each participant will be supplied with the equivalent of nine 75 µg/kg doses, which aligns with the recommended dosing schedule as provided in SEVENFACT's United States Prescribing Information (USPI). In the event of a bleeding episode (BE), the participant will either self-administer the correct dose under the guidance of the treating investigator or the dose will be administered at a treatment facility.

Interventions

coagulation factor VIIa [recombinant]-jncw

a transgenically produced, activated, recombinant, human factor VII (rhFVIIa) protein with the brand name of SEVENFACT®. This protein is a clotting factor in the coagulation cascade that is produced in and purified from the milk of transgenic rabbits. SEVENFACT is approved for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.

Primary outcome measure

  • Number of participants and percentage of Safety Events (AEs) [ Time Frame: From time of consent through BE onset until 3 days after last dose of SEVENFACT®. ]

Central Contacts and Locations

Central contacts

Locations

Arkansas Center for Bleeding Disorders

Recruiting

Little Rock, Arkansas, United States, 72202

Contacts

Principal Investigator:

Shelley Crary, MD

Orthopaedic Institute for Children

Recruiting

Los Angeles, California, United States, 90007

Contacts

Doris Quon, MD

dquon@mednet.ucla.edu

Principal Investigator:

Doris Quon, MD

University of California at Davis UC Davis Hemostasis and Thrombosis Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Principal Investigator:

Kim Schafer, RN, FNP

Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division

Recruiting

Atlanta, Georgia, United States, 31404

Contacts

Megan Brown, MD

megan.brown@emory.edu

Principal Investigator:

Megan Brown, MD

Willett Children's Hospital at Memorial University Medical Center

Recruiting

Savannah, Georgia, United States, 31404

Contacts

Principal Investigator:

Ashley Eason

Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Principal Investigator:

Eric Grabowski, MD

Children's Hospital of Michigan

Recruiting

Detroit, Michigan, United States, 48201

Contacts

Meera Chitlur, MD

mchitlur@dmc.org

Principal Investigator:

Meera Chitlur, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

Philip Kuriakose, MD

pkuriak1@hfhs.org

Principal Investigator:

Philip Kuriakose, MD

MSU Center for Bleeding and Clotting Disorders

Recruiting

Lansing, Michigan, United States, 48912

Contacts

Anna Burghardt

annarn@msu.edu

Principal Investigator:

Shiva Shrotriya, MD

Kansas City Regional Hemophilia Center

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Principal Investigator:

Lauren Amos, MD

Northwell Health, Long Island Jewish

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Suchitra Acharya, MD

Sacharya@northwell.edu

Principal Investigator:

Suchitra Acharya, MD

University Hospitals Health System Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

John Letterio, MD

Oklahoma Center for Bleeding and Clotting Disorders

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Osman Khan, MD

osman-khan@ouhsc.edu

Principal Investigator:

Osman Khan, MD

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37212

Contacts

Principal Investigator:

Shannon Walker, MD

Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Miguel Escobar, MD

Miguel.Escobar@uth.tmc.edu

Principal Investigator:

Miguel Escobar, MD

More Information

Sponsor

American Thrombosis and Hemostasis Network

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by American Thrombosis and Hemostasis Network on 2026-01-12.