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 : May 10, 2022
|Condition or disease||Intervention/treatment||Phase|
|Hemophilia A With Inhibitor Hemophilia B With Inhibitor||Drug: coagulation factor VIIa [recombinant]-jncw||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|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)|
|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 :||October 31, 2023|
|Estimated Study Completion Date :||June 1, 2025|
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
- 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.
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
|Contact: Carol Fedor, ND, RN, CCRC||(800)-360-2846 ext firstname.lastname@example.org|
|Contact: Jessica Callis||800-360-2846 ext email@example.com|
|Principal Investigator:||Tammuella Chrisentery-Singleton, MD||Louisiana Center for Advanced Medicine|
|Principal Investigator:||Mark Reding, MD||University of Minnesota|