Hemophilia A With InhibitorPhase 4NCT04647227
SEVENFACT® for Bleeding Events in Hemophilia With Inhibitors
A Phase 4 study testing coagulation factor VIIa [recombinant]-jncw in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by American Thrombosis and Hemostasis Network at 21 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 100 years
- Conditions the study is for
- Hemophilia A With Inhibitor, Hemophilia B With Inhibitor
- What is being tested?
- coagulation factor VIIa [recombinant]-jncw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 21 sitesUnited States
- Study dates
- 28 Jun 2021to 31 Mar 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a diagnosis of hemophilia A or B with inhibitors.
- Be 12 years of age and older
- 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
- Have read, understood, and documented written informed consent/assent
- Be able to provide medical evidence through prior medical history of previous inhibitor levels
- Be willing and able to use the ATHN mobile application or a paper diary to document BEs and medication usage
Who cannot join
- Have a disorder of hemostasis in addition to Hemophilia A or B
- Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
- Have a known allergy or hypersensitivity to rabbits or rabbit proteins
- Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
- Have had implantation of an investigational medical device within the prior 6 months
- Have received an investigational drug within 30 days of the baseline visit
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- Have an elective surgical procedure planned during the duration of their participation in the study*
- 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.
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 17 recruiting
- Recruiting
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
Atlanta, Georgia, 31404
Megan Brown, MD, megan.brown@emory.edu
Megan Brown, MD
- Recruiting
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
Boston, Massachusetts, 02114
Carmen Zhou, 617-726-2737, czhou12@mgh.harvard.edu
Eric Grabowski, MD
- Recruiting
University Hospitals Health System Cleveland
Cleveland, Ohio, 44106
Julia Martiradonna, 216-844-3329, Julia.martiradonna@uhhospitals.org
John Letterio, MD
- Recruiting
Children's Hospital of Michigan
Detroit, Michigan, 48201
Meera Chitlur, MD, mchitlur@dmc.org
Meera Chitlur, MD
- Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Philip Kuriakose, MD, pkuriak1@hfhs.org
Philip Kuriakose, MD
- Not yet recruiting
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
Darla Liles
Darla Liles, MD
- Recruiting
Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston
Houston, Texas, 77030
Miguel Escobar, MD, Miguel.Escobar@uth.tmc.edu
Miguel Escobar, MD
- Recruiting
Kansas City Regional Hemophilia Center
Kansas City, Missouri, 64108
Eryn Bilynsky, 816-302-6853, erbilynsky@cmh.edu
Lauren Amos, MD
- Recruiting
MSU Center for Bleeding and Clotting Disorders
Lansing, Michigan, 48912
Anna Burghardt, annarn@msu.edu
Shiva Shrotriya, MD
- Recruiting
Arkansas Center for Bleeding Disorders
Little Rock, Arkansas, 72202
Carol Pierce, RN, 501-364-1076, piercecarold@uams.edu
Shelley Crary, MD
- Recruiting
Orthopaedic Institute for Children
Los Angeles, California, 90007
Doris Quon, MD, dquon@mednet.ucla.edu
Doris Quon, MD
- Not yet recruiting
Center for Bleeding and Clotting Disorders, University of Minnesota
Minneapolis, Minnesota, 55455
Mark Reding, MD
Mark Reding, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Alyssa Weakley, alyssa.weakley@vumc.org
Shannon Walker, MD
- Recruiting
Northwell Health, Long Island Jewish
New Hyde Park, New York, 11040
Suchitra Acharya, MD, Sacharya@northwell.edu
Suchitra Acharya, MD
- Recruiting
Oklahoma Center for Bleeding and Clotting Disorders
Oklahoma City, Oklahoma, 73104
Osman Khan, MD, osman-khan@ouhsc.edu
Osman Khan, MD
- Completed
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
Orlando, Florida, 32806
- Completed
Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Completed
Mayo Comprehensive Hemophilia Center
Rochester, Minnesota, 55905
- Recruiting
University of California at Davis UC Davis Hemostasis and Thrombosis Center
Sacramento, California, 95817
Celynn Knight, ceknight@ucdavis.edu
Kim Schafer, RN, FNP
- Recruiting
Willett Children's Hospital at Memorial University Medical Center
Savannah, Georgia, 31404
Alta Castellano, RN, Alta.Castellino@hcahealthcare.com
Ashley Eason
- Completed
Children's National Hemophilia Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors
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.
Read the detailed description
Primary Objective:
To evaluate the safety of SEVENFACT® when used to treat bleeding episodes in participants with Hemophilia A or B with inhibitors either with or without prophylactic treatment
Study Design:
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A and 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.
Study Duration:
Participants will be followed longitudinally from the time of enrollment to the end of their participation in the study. The maximal study duration for any participant in the study will be approximately 4 years from the time of enrollment.
Target Accrual:
This is a multi-site study in which it is anticipated approximately 28 to 55 participants will be enrolled. The study will target enrollment of participants with Hemophilia A and B with inhibitors on prophylaxis with FDA-approved therapies. Enrollment will continue until September 30, 2026, or until the time that the 28th participant is enrolled, whichever comes first.
Data Analysis:
Sample Size Determination:
Results from the study (March 19, 2024, data transfer) with 19 participants enrolled and 3 participant discontinuations were used to calculate the annual bleeding rate for participants receiving prophylactic treatment. Adjusted annualized bleeding rate was calculated at 0.58.
Based on these data, up to 28 participants with hemophilia A and B with inhibitors on FDA-approved prophylaxis treatments will be attempted to enroll.
Analysis Populations:
The Safety Analysis Set is defined as all participants who received at least a single dose of SEVENFACT®. All analyses of safety will be performed based on the safety population, and participants will be analyzed according to the dose of SEVENFACT® that they actually received.
Baseline Characteristics:
Baseline characteristics will be summarized using descriptive statistics for continuous variables, and frequencies and percentages for categorical variables.
Safety Evaluations:
All Adverse Events (AEs) will be graded for severity utilizing Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and coded using Medical Dictionary of Regulatory Activities (MedDRA) version 23.x. The number and percentage of participants with treatment-emergent AEs (TEAEs), serious AEs (SAEs), serious TEAEs and treatment related TEAEs (i.e., adverse drug reactions [ADRs]) will be presented for all participants.
The number of TEAEs, as well as the number and percentage of participants with TEAEs, serious TEAEs, and treatment-related TEAEs will be presented by MedDRA System Organ Class (SOC) and preferred term for all participants.
The number and percentage of participants with treatment-emergent adverse event and/or allergic and anaphylactic reactions will be presented for all participants.
Efficacy Evaluations:
There are no pre-specified efficacy endpoints.
Interim Analysis:
An interim analysis will be conducted after 20 participants have been enrolled into the study. The analysis will seek to characterize baseline, disease, dosing and safety outcome profiles of participants treated with SEVENFACT.
- Being tested
- coagulation factor VIIa [recombinant]-jncw
- Keywords
- Hemophilia A, Hemophilia B, bleeding event, prophylactic treatment
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coagulation factor VIIa [recombinant]-jncwDrug
Also called SEVENFACT
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia A and B Cases | Other | 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. Receives: Drug: coagulation factor VIIa [recombinant]-jncw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants and percentage of Safety Events (AEs)
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.
Measured: From time of consent through BE onset until 3 days after last dose of SEVENFACT®.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start28 Jun 2021
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia A With InhibitorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- ATHN 16 is a phase IV multi-center, US-centric, open-label, safety study
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American Thrombosis and Hemostasis Network
- Sponsor type
- Research network
- Collaborators
- LFB USA, Inc.
- Responsible party
- Sponsor
- Investigators
- Tammuella Chrisentery-Singleton, MD, Principal investigator, American Thrombosis and Hemostasis NetworkMark Reding, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647227
- Sponsor's protocol ID
- ATHN 16
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2020
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chrisentery-Singleton T, Acharya S, Ahuja S, Amos LE, Chitlur M, Daoud N, Eason A, Escobar M, Fedor C, Gupta S, Kuriakose P, Nasr S, Pennington S, Pruthi RK, Recht M, Robertson A, Quon DV, Wheeler AP, Reding M. Safety and real-world effectiveness of eptacog beta with emicizumab prophylaxis: an interim analysis of the ATHN 16 study. Blood Vessel Thromb Hemost. 2026 Apr 19;3(3):100169. doi: 10.1016/j.bvth.2026.100169. eCollection 2026 Aug.
PubMed 42382314
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of SEVENFACT® for the Treatment of Bleeding Events in Patients With Hemophilia A or B With Inhibitors
- ClinicalTrials.gov ID
- NCT04647227
- Acronym / sponsor ID
- ATHN 16
- Keywords
- Hemophilia A, Hemophilia B, bleeding event, prophylactic treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- American Thrombosis and Hemostasis NetworkResearch network
- Collaborators
- LFB USA, Inc.
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective:
To evaluate the safety of SEVENFACT® when used to treat bleeding episodes in participants with Hemophilia A or B with inhibitors either with or without prophylactic treatment
Study Design:
Phase IV multi-center, US-centric, open-label, safety study enrolling participants with Hemophilia A and 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.
Study Duration:
Participants will be followed longitudinally from the time of enrollment to the end of their participation in the study. The maximal study duration for any participant in the study will be approximately 4 years from the time of enrollment.
Target Accrual:
This is a multi-site study in which it is anticipated approximately 28 to 55 participants will be enrolled. The study will target enrollment of participants with Hemophilia A and B with inhibitors on prophylaxis with FDA-approved therapies. Enrollment will continue until September 30, 2026, or until the time that the 28th participant is enrolled, whichever comes first.
Data Analysis:
Sample Size Determination:
Results from the study (March 19, 2024, data transfer) with 19 participants enrolled and 3 participant discontinuations were used to calculate the annual bleeding rate for participants receiving prophylactic treatment. Adjusted annualized bleeding rate was calculated at 0.58.
Based on these data, up to 28 participants with hemophilia A and B with inhibitors on FDA-approved prophylaxis treatments will be attempted to enroll.
Analysis Populations:
The Safety Analysis Set is defined as all participants who received at least a single dose of SEVENFACT®. All analyses of safety will be performed based on the safety population, and participants will be analyzed according to the dose of SEVENFACT® that they actually received.
Baseline Characteristics:
Baseline characteristics will be summarized using descriptive statistics for continuous variables, and frequencies and percentages for categorical variables.
Safety Evaluations:
All Adverse Events (AEs) will be graded for severity utilizing Common Terminology Criteria for Adverse Events (CTCAE) v5.0 and coded using Medical Dictionary of Regulatory Activities (MedDRA) version 23.x. The number and percentage of participants with treatment-emergent AEs (TEAEs), serious AEs (SAEs), serious TEAEs and treatment related TEAEs (i.e., adverse drug reactions [ADRs]) will be presented for all participants.
The number of TEAEs, as well as the number and percentage of participants with TEAEs, serious TEAEs, and treatment-related TEAEs will be presented by MedDRA System Organ Class (SOC) and preferred term for all participants.
The number and percentage of participants with treatment-emergent adverse event and/or allergic and anaphylactic reactions will be presented for all participants.
Efficacy Evaluations:
There are no pre-specified efficacy endpoints.
Interim Analysis:
An interim analysis will be conducted after 20 participants have been enrolled into the study. The analysis will seek to characterize baseline, disease, dosing and safety outcome profiles of participants treated with SEVENFACT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- ATHN 16 is a phase IV multi-center, US-centric, open-label, safety study
| Arm | Type | Receives |
|---|---|---|
| Hemophilia A and B Cases | Other | Drug: coagulation factor VIIa [recombinant]-jncwSEVENFACT® 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. |
Who may qualify
- Ages
- 12 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Have a diagnosis of hemophilia A or B with inhibitors.
- Be 12 years of age and older
- 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
- Have read, understood, and documented written informed consent/assent
- Be able to provide medical evidence through prior medical history of previous inhibitor levels
Key exclusion criteria (9 listed)
- Have a disorder of hemostasis in addition to Hemophilia A or B
- Have a known or suspected intolerance or hypersensitivity to SEVENFACT® or its ingredients
- Have a known allergy or hypersensitivity to rabbits or rabbit proteins
- Are receiving prophylactic treatment for bleeding with a drug or biologic that is not approved for this use by the FDA
- Have had implantation of an investigational medical device within the prior 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coagulation factor VIIa [recombinant]-jncwAlso: SEVENFACTa 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. | Drug | Hemophilia A and B Cases |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Derived from this study: PubMed 42382314Chrisentery-Singleton T, Acharya S, Ahuja S, Amos LE, Chitlur M, Daoud N, Eason A, Escobar M, Fedor C, Gupta S, Kuriakose P, Nasr S, Pennington S, Pruthi RK, Recht M, Robertson A, Quon DV, Wheeler AP, Reding M. Safety and real-world effectiveness of eptacog beta with emicizumab prophylaxis: an interim analysis of the ATHN 16 study. Blood Vessel Thromb Hemost. 2026 Apr 19;3(3):100169. doi: 10.1016/j.bvth.2026.100169. eCollection 2026 Aug.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tammuella Chrisentery-Singleton, MD principal investigator
American Thrombosis and Hemostasis Network
Mark Reding, MD principal investigator
University of Minnesota
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing coagulation factor VIIa [recombinant]-jncw in people with Hemophilia A With Inhibitor and Hemophilia B With Inhibitor, run by American Thrombosis and Hemostasis Network at 21 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol Fedor, ND, RN, CCRC ((800)-360-2846 ext. 122, cfedor@athn.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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®.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04647227, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.