A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
NCT ID: NCT05911763
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2023-06-30
2030-09-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort A (Prophylactic treatment)
All participants on efanesoctocog alfa prophylactic treatment fulfilling the overall study inclusion/exclusion criteria. The prophylactic cohort will include the following sub-cohorts:
Sub-cohort A1 (Joint imaging): Participants with severe hemophilia A and joint imaging by Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) or Joint Tissue Activity and Damage Exam (JADE) protocol performed within 6 months of initiating treatment with efanesoctocog alfa or within 3 months after initiating treatment with efanesoctocog alfa available.
Sub-cohort A2 (Children with no prior joint damage):Participants with severe hemophilia A who have no prior joint damage
Efanesoctocog Alfa BIVV001
Given per investigator's discretion
Cohort B (On-Demand treatment)
Participants receiving on-demand treatment with efanesoctocog alfa who fulfil the overall study inclusion/exclusion criteria
Efanesoctocog Alfa BIVV001
Given per investigator's discretion
Interventions
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Efanesoctocog Alfa BIVV001
Given per investigator's discretion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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."
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Banner MD Anderson Cancer Center- Site Number : 8400008
Gilbert, Arizona, United States
Loma Linda University- Site Number : 8400015
Loma Linda, California, United States
Orthopedic Institute for Children- Site Number : 8400004
Los Angeles, California, United States
The Center for Inherited Blood Disorders- Site Number : 8400001
Orange, California, United States
University of Colorado Hemophilia and Thrombosis Center- Site Number : 8400019
Aurora, Colorado, United States
William A. Shands Hospital at the University of Florida- Site Number : 8400032
Gainesville, Florida, United States
Johns Hopkins All Childrens Hospital - Outpatient Care Center - PIN- Site Number : 8400025
St. Petersburg, Florida, United States
Rush University Medical Center -1725 W Harrison St- Site Number : 8400014
Chicago, Illinois, United States
The Bleeding and Clotting Disorders Institute- Site Number : 8400005
Peoria, Illinois, United States
Indiana Hemophilia and Thrombosis Center- Site Number : 8400013
Indianapolis, Indiana, United States
University Of Iowa Hospitals And Clinics- Site Number : 8400026
Iowa City, Iowa, United States
~Massachusetts General Hospital- Site Number : 8400017
Boston, Massachusetts, United States
Dana Farber and Boston Children's Hospital- Site Number : 8400031
Boston, Massachusetts, United States
University of Michigan Hospital - 1500 E Medical Center Dr- Site Number : 8400023
Ann Arbor, Michigan, United States
M Health Fairview- Masonic Cancer Clinic - Clinics- Site Number : 8400010
Minneapolis, Minnesota, United States
Mayo Clinic - PPDS- Site Number : 8400035
Rochester, Minnesota, United States
Mississippi Center For Advanced Medicine - 7731 Old Canton Rd- Site Number : 8400016
Madison, Mississippi, United States
University of Nebraska Medical Center - 985400 Nebraska Medical Center- Site Number : 8400009
Omaha, Nebraska, United States
Children's Specialty Center - Las Vegas- Site Number : 8400007
Las Vegas, Nevada, United States
Weill Cornell Medicine-New York Presbyterian Hospital- Site Number : 8400021
New York, New York, United States
Cincinnati Children's Hospital Medical Center - PIN- Site Number : 8400006
Cincinnati, Ohio, United States
Hemophilia Center of Western Pennsylvania- Site Number : 8400012
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center- Site Number : 8400003
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center-2001 Inwood Rd- Site Number : 8400020
Dallas, Texas, United States
University of Texas Southwestern Medical Center- Site Number : 8400011
Dallas, Texas, United States
Gulf States Hemophilia and Thrombophilia Center- Site Number : 8400029
Houston, Texas, United States
Washington Institute for Coagulation- Site Number : 8400022
Seattle, Washington, United States
Blood Center of Wisconnsin- Site Number : 8400027
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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U1111-1281-8840
Identifier Type: REGISTRY
Identifier Source: secondary_id
OBS17523
Identifier Type: -
Identifier Source: org_study_id
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