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A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
Led by Sanofi · Updated on 2025-10-02
100
Participants Needed
10
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A in Taiwan
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of all ages diagnosed with moderate to severe hemophilia A without current or at least three years of undetectable inhibitor (<0.6 BU)
- FVIII level less than or equal to 5%
- Participants who started efanesoctocog alfa prophylaxis within three months before enrollment
- Participants aged 6 years and older able to undergo MRI examinations (with sedation if needed)
- Participants able to undergo joint examinations
- Physician's decision to treat with efanesoctocog alfa made before study participation
- Signed informed consent provided by participant or legal representative; assent obtained for pediatric participants as required
You will not qualify if you...
- Participants with coagulation disorders other than hemophilia A
- Participants diagnosed with other known bleeding disorders
- Participants currently receiving factor therapy with decreased response to FVIII
- Participants with baseline Radiological Pettersson score greater than 6 for each ankle
- Participants enrolled in another interventional clinical study or investigational product use within 3 months
- Pregnant female participants
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Investigational Site Number : 1580008
Changhua, Taiwan, 500
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2
Investigational Site Number : 1580009
Kaohsiung City, Taiwan, 807
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3
Investigational Site Number : 1580010
Kaohsiung City, Taiwan, 83301
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4
Investigational Site Number : 1580005
Taichung, Taiwan, 40201
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5
Investigational Site Number : 1580006
Taichung, Taiwan, 40447
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6
Investigational Site Number : 1580007
Taichung, Taiwan, 40705
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7
Investigational Site Number : 1580001
Taipei, Taiwan, 100
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8
Investigational Site Number : 1580003
Taipei, Taiwan, 110
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9
Investigational Site Number : 1580002
Taipei, Taiwan, 114
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10
Investigational Site Number : 1580004
Taoyuan City, Taiwan, 33305
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Research Team
T
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CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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