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A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
Sponsor: Sanofi
Summary
This is a national, multicenter, retrospective/prospective, observational study in Taiwan designed to assess effectiveness, safety, and usage of efanesoctocog alfa prophylaxis treatment in hemophilia A participants. The data related to efanesoctocog alfa effectiveness, safety and usage will be recorded prospectively during routine visits for up to 5 years following enrollment initiation and the retrospective data will be collected at least 12 months and up to 24 months prior to efanesoctocog alfa initiation. Joint imaging data will be collected in centers performing Joint U/S and/or MRI (≥6 years old). At least 12 months of retrospective data will also be collected from medical records, as available. Prospectively collected data will be recorded at routine clinical visits during a five-year follow-up period. The end of study is defined as the last participant's last visit. No intervention will be administered, and no study related visits are required.
Official title: PROphylactic Efanesoctocog Alfa Therapy Evaluated for Critical Joint Health in Hemophilia A Treatment: The PROTECT-ALT Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2024-11-11
Completion Date
2031-08-28
Last Updated
2025-10-02
Healthy Volunteers
No
Conditions
Interventions
Efanesoctocog alfa
This study will not administer any treatment, only observe the treatment as prescribed in real-world clinical practices.
Locations (10)
Investigational Site Number : 1580008
Changhua, Taiwan
Investigational Site Number : 1580009
Kaohsiung City, Taiwan
Investigational Site Number : 1580010
Kaohsiung City, Taiwan
Investigational Site Number : 1580005
Taichung, Taiwan
Investigational Site Number : 1580006
Taichung, Taiwan
Investigational Site Number : 1580007
Taichung, Taiwan
Investigational Site Number : 1580001
Taipei, Taiwan
Investigational Site Number : 1580003
Taipei, Taiwan
Investigational Site Number : 1580002
Taipei, Taiwan
Investigational Site Number : 1580004
Taoyuan, Taiwan