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SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04647227
Recruitment Status : Recruiting
First Posted : November 30, 2020
Last Update Posted : June 2, 2023
Sponsor:
Collaborator:
LFB USA, Inc.
Information provided by (Responsible Party):
American Thrombosis and Hemostasis Network

Study Description
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Brief Summary:
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A or B with inhibitors12 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.

Condition or disease Intervention/treatment Phase
Hemophilia A With Inhibitor Hemophilia B With Inhibitor Drug: coagulation factor VIIa [recombinant]-jncw Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: ATHN 16 is a phase IV multi-center, US-centric, open-label, safety study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors
Actual Study Start Date : June 28, 2021
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : June 1, 2025

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Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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.
Other Name: SEVENFACT


Outcome Measures
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Primary Outcome Measures :
  1. 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®. ]
    Adverse Events and SAEs defined by the European Haemophilia Safety Surveillance System 2018 (EUHASS) and Serious Adverse Events (SAEs) as defined by the US Food and Drug Association.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647227


Contacts
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Contact: Carol Fedor, ND, RN, CCRC (800)-360-2846 ext 122 cfedor@athn.org
Contact: Jessica Callis 800-360-2846 ext 123 jcallis@athn.org

Locations
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Sponsors and Collaborators
American Thrombosis and Hemostasis Network
LFB USA, Inc.
Investigators
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Principal Investigator: Tammuella Chrisentery-Singleton, MD Louisiana Center for Advanced Medicine
Principal Investigator: Mark Reding, MD University of Minnesota
More Information
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Responsible Party: American Thrombosis and Hemostasis Network
ClinicalTrials.gov Identifier: NCT04647227    
Other Study ID Numbers: ATHN 16
First Posted: November 30, 2020    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by American Thrombosis and Hemostasis Network:
Hemophilia A
Hemophilia B
bleeding event
prophylactic treatment
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Hemorrhage
Pathologic Processes
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
 Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked