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New Real-World study tracks joint protection in hemophilia a patients

NCT ID NCT05911763

Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows about 200 people with hemophilia A who are already taking a medicine called efanesoctocog alfa as part of their routine care. Researchers want to see how well it protects joints from bleeding over 5 years. No new treatments are given—just observation of real-world results.

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.

Participants

About 200 people

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

Started

Jun 2023

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Approximately 200 patients from sites in the US and Japan will be enrolled in the study after the introduction of efanesoctocog alfa in the hemophilia treatment landscape in each of these two countries. To generate data for the broad real-world population of individuals with hemophilia A, eligible patients will include all ages, sexes and hemophilia A severities, whether on prophylactic or on-demand therapy or if efanesoctocog alfa is taken perioperatively.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Have a diagnosis of hemophilia A * Patients starting efanesoctocog alfa treatment as per standard of care no more than one month prior to the enrollment date, for either on demand or prophylaxis. Patients starting efanesoctocog alfa treatment for a surgery event may also be enrolled only if the treatment is prescribed at enrollment. * Physician's decision to treat the patient with efanesoctocog alfa is made prior to and independently of participation in the study. * Signed and dated informed consent provided by the patient, or by the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained for pediatric patients according to local regulations. Exclusion Criteria: Diagnosed with other known bleeding disorder * Participation in an investigational medicinal product trial at enrollment visit, or intake of an Investigational Medicinal Product within 3 months prior to inclusion in this study * Current diagnosis of a FVIII inhibitor, defined as inhibitor titer ≥0.60 BU/mL "The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."

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Conditions

The condition(s) this trial relates to.

hemophilia A

As listed by the trial registrant

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

Hemophilia A

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center- Site Number : 8400008

    Gilbert, Arizona, 85234-2165, United States

  • Blood Center of Wisconnsin- Site Number : 8400027

    Milwaukee, Wisconsin, 53233-2121, United States

  • Children's Specialty Center - Las Vegas- Site Number : 8400007

    Las Vegas, Nevada, 89109, United States

  • Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400006

    Cincinnati, Ohio, 45229-3026, United States

  • Dana Farber and Boston Children's Hospital- Site Number : 8400031

    Boston, Massachusetts, 02215-5418, United States

  • Gulf States Hemophilia and Thrombophilia Center- Site Number : 8400029

    Houston, Texas, 77030, United States

  • Hemophilia Center of Western Pennsylvania- Site Number : 8400012

    Pittsburgh, Pennsylvania, 15213-4306, United States

  • Indiana Hemophilia and Thrombosis Center- Site Number : 8400013

    Indianapolis, Indiana, 46260-1920, United States

  • Johns Hopkins All Childrens Hospital - Outpatient Care Center - PIN- Site Number : 8400025

    St. Petersburg, Florida, 33701-4804, United States

  • Loma Linda University- Site Number : 8400015

    Loma Linda, California, 92354-3450, United States

  • M Health Fairview- Masonic Cancer Clinic - Clinics- Site Number : 8400010

    Minneapolis, Minnesota, 55455-4800, United States

  • Mayo Clinic - PPDS- Site Number : 8400035

    Rochester, Minnesota, 55905-0001, United States

  • Mississippi Center For Advanced Medicine - 7731 Old Canton Rd- Site Number : 8400016

    Madison, Mississippi, 39110-6115, United States

  • Orthopedic Institute for Children- Site Number : 8400004

    Los Angeles, California, 90007, United States

  • Rush University Medical Center -1725 W Harrison St- Site Number : 8400014

    Chicago, Illinois, 60612-3863, United States

  • The Bleeding and Clotting Disorders Institute- Site Number : 8400005

    Peoria, Illinois, 61615, United States

  • The Center for Inherited Blood Disorders- Site Number : 8400001

    Orange, California, 92868, United States

  • University Of Iowa Hospitals And Clinics- Site Number : 8400026

    Iowa City, Iowa, 52242-1009, United States

  • University of Colorado Hemophilia and Thrombosis Center- Site Number : 8400019

    Aurora, Colorado, 80045-7202, United States

  • University of Michigan Hospital - 1500 E Medical Center Dr- Site Number : 8400023

    Ann Arbor, Michigan, 48109-5000, United States

  • University of Nebraska Medical Center - 985400 Nebraska Medical Center- Site Number : 8400009

    Omaha, Nebraska, 68114-4113, United States

  • University of Texas Southwestern Medical Center- Site Number : 8400011

    Dallas, Texas, 75390-8565, United States

  • University of Texas Southwestern Medical Center-2001 Inwood Rd- Site Number : 8400020

    Dallas, Texas, 75390-7202, United States

  • Vanderbilt University Medical Center- Site Number : 8400003

    Nashville, Tennessee, 37232-0011, United States

  • Washington Institute for Coagulation- Site Number : 8400022

    Seattle, Washington, 98101-3932, United States

  • Weill Cornell Medicine-New York Presbyterian Hospital- Site Number : 8400021

    New York, New York, 10065-4870, United States

  • William A. Shands Hospital at the University of Florida- Site Number : 8400032

    Gainesville, Florida, 32610-3003, United States

  • ~Massachusetts General Hospital- Site Number : 8400017

    Boston, Massachusetts, 02114, United States

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