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RECRUITING
NCT06684314

A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan

Sponsor: Sanofi

View on ClinicalTrials.gov

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

DRUG

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