Rabbit-Milk clotting drug tested for hemophilia bleeds

NCT ID NCT04647227

Disease control Sponsor: American Thrombosis and Hemostasis Network Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing the safety of a drug called SEVENFACT, a clotting factor made from the milk of genetically modified rabbits, in people aged 12 and older with hemophilia A or B who have inhibitors. The drug is already approved for treating bleeding episodes, and this trial will monitor side effects in 55 participants across the US. It is an open-label study, meaning everyone knows they are getting the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: SEVENFACT (a clotting factor made from rabbit milk)
What this could lead to: If successful, this could confirm that SEVENFACT is a safe option to control bleeding episodes in people with hemophilia who have inhibitors.
What could go wrong: This is a small, early-phase safety study (55 people) with no comparison group, so it cannot prove effectiveness. Side effects like allergic reactions or blood clots are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 55 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

hemophilia A hemophilia B

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hemophilia A with inhibitor Hemophilia B with inhibitor

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

17 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Arizona Hemophilia and Thrombosis Center at Phoenix Children's Hospital
COMPLETED

Phoenix, Arizona, 85016, United States
Arkansas Center for Bleeding Disorders
RECRUITING

Little Rock, Arkansas, 72202, United States
Arnold Palmer Hospital for Children - The Haley Center for Children's Cancer and Blood Disorders
COMPLETED

Orlando, Florida, 32806, United States
Brody School of Medicine at East Carolina University
NOT_YET_RECRUITING

Greenville, North Carolina, 27834, United States
Center for Bleeding and Clotting Disorders, University of Minnesota
NOT_YET_RECRUITING

Minneapolis, Minnesota, 55455, United States
Children's Hospital of Michigan
RECRUITING

Detroit, Michigan, 48201, United States
Children's National Hemophilia Center
COMPLETED

Washington D.C., District of Columbia, 20010, United States
Gulf States Hemophilia and Thrombophilia Center-University of Texas Health Science Center @Houston
RECRUITING

Houston, Texas, 77030, United States
Hemophilia of Georgia Center for Bleeding and Clotting Disorders of Emory, Adult Division
RECRUITING

Atlanta, Georgia, 31404, United States
Henry Ford Health System
RECRUITING

Detroit, Michigan, 48202, United States
Kansas City Regional Hemophilia Center
RECRUITING

Kansas City, Missouri, 64108, United States
MSU Center for Bleeding and Clotting Disorders
RECRUITING

Lansing, Michigan, 48912, United States
Massachusetts General Hospital Comprehensive Hemophilia and Thrombosis Treatment Center
RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Comprehensive Hemophilia Center
COMPLETED

Rochester, Minnesota, 55905, United States
Northwell Health, Long Island Jewish
RECRUITING

New Hyde Park, New York, 11040, United States
Oklahoma Center for Bleeding and Clotting Disorders
RECRUITING

Oklahoma City, Oklahoma, 73104, United States
Orthopaedic Institute for Children
RECRUITING

Los Angeles, California, 90007, United States
University Hospitals Health System Cleveland
RECRUITING

Cleveland, Ohio, 44106, United States
University of California at Davis UC Davis Hemostasis and Thrombosis Center
RECRUITING

Sacramento, California, 95817, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37212, United States
Willett Children's Hospital at Memorial University Medical Center
RECRUITING

Savannah, Georgia, 31404, United States

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