NCT05911763Active, not recruiting
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
Prospective, Observational , Multicenter Study of Effectiveness of Efanesoctocog Alfa on Long-term Joint Health in Patients With Hemophilia A
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
This is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in the US and Japan. Patients will be enrolled in the study after the introduction of efanesoctocog alfa in the hemophilia treatment landscape in each study country. Decision to initiate treatment with commercially available efanesoctocog alfa will be made by the treating physician independently from the decision to include patients in the study. No study medication is provided. The data related to efanesoctocog alfa effectiveness, safety and usage will be collected prospectively during routine visits (expected annual/semi-annual visits) for up to 5 years following enrollment /treatment initiation.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 12 May 2023
- Start date
- 30 Jun 2023
- Primary completion date
- 6 Jun 2028
- Lead sponsor
- Sanofi
- Diseases
- Haemophilia
- NCT number
- NCT05911763
What you commit to
- Study type: Observational
- Planned participants: 200
- From 30 Jun 2023 to the primary completion date, 6 Jun 2028
- 28 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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."
Other illness
- Diagnosed with other known bleeding disorder
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (28)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Hospital - 1500 E Medical Center Dr- Site Number : 8400023 Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| University of Colorado Hemophilia and Thrombosis Center- Site Number : 8400019 Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| ~Massachusetts General Hospital- Site Number : 8400017 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Dana Farber and Boston Children's Hospital- Site Number : 8400031 Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Rush University Medical Center -1725 W Harrison St- Site Number : 8400014 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400006 Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University of Texas - Southwestern Medical Center- Site Number : 8400011 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Texas Southwestern Medical Center-2001 Inwood Rd- Site Number : 8400020 Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| William A. Shands Hospital at the University of Florida- Site Number : 8400032 Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Banner MD Anderson Cancer Center- Site Number : 8400008 Coordinator of this site? Confirm its status | Gilbert | United States | Unknown status |
| Gulf States Hemophilia and Thrombophilia Center- Site Number : 8400029 Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana Hemophilia and Thrombosis Center- Site Number : 8400013 Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University Of Iowa Hospitals And Clinics- Site Number : 8400026 Coordinator of this site? Confirm its status | Iowa City | United States | Unknown status |
| Children's Specialty Center - Las Vegas- Site Number : 8400007 Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Loma Linda University- Site Number : 8400015 Coordinator of this site? Confirm its status | Loma Linda | United States | Unknown status |
| Orthopedic Institute for Children- Site Number : 8400004 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Mississippi Center For Advanced Medicine - 7731 Old Canton Rd- Site Number : 8400016 Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Blood Center of Wisconnsin- Site Number : 8400027 Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| M Health Fairview- Masonic Cancer Clinic - Clinics- Site Number : 8400010 Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| Vanderbilt University Medical Center- Site Number : 8400003 Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Weill Cornell Medicine-New York Presbyterian Hospital- Site Number : 8400021 Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Nebraska Medical Center - 985400 Nebraska Medical Center- Site Number : 8400009 Coordinator of this site? Confirm its status | Omaha | United States | Unknown status |
| The Center for Inherited Blood Disorders- Site Number : 8400001 Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| The Bleeding and Clotting Disorders Institute- Site Number : 8400005 Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Hemophilia Center of Western Pennsylvania- Site Number : 8400012 Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Mayo Clinic - PPDS- Site Number : 8400035 Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Washington Institute for Coagulation- Site Number : 8400022 Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
| Johns Hopkins All Childrens Hospital - Outpatient Care Center - PIN- Site Number : 8400025 Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.