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A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A
Sponsor: Sanofi
Summary
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.
Official title: Prospective, Observational , Multicenter Study of Effectiveness of Efanesoctocog Alfa on Long-term Joint Health in Patients With Hemophilia A
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
200
Start Date
2023-06-30
Completion Date
2030-09-17
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
Efanesoctocog Alfa BIVV001
Given per investigator's discretion
Locations (28)
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