Actively Recruiting
Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
Led by Sanofi · Updated on 2025-11-18
35
Participants Needed
13
Research Sites
108 weeks
Total Duration
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AI-Summary
What this Trial Is About
The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A. The study duration for each participant is approximately 12 months.
CONDITIONS
Official Title
Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with moderate to severe hemophilia A (endogenous FVIII clotting activity ≤5%)
- At least 12 years old at the time of consent
- Has synovial hypertrophy in at least one eligible joint with HEAD-US synovitis score 1 or 2
- Has at least one eligible joint without planned major orthopedic procedures or surgery in past 3 months
- Received hemophilia prophylactic treatment in the last 12 months prior to baseline
- Can understand and sign informed consent or assent
- If female, is not pregnant or breastfeeding and either not childbearing or agrees to use highly effective contraception with negative pregnancy test at screening
- If male, no contraceptive measures required
You will not qualify if you...
- Has other clotting disorders at the time of consent
- Currently receiving efanesoctocog alfa treatment
- Has factor VIII inhibitor with titer ≥0.60 BU/mL
- Received immune tolerance induction within 2 years prior to baseline
- Enrolled in other clinical interventional studies or exposed to investigational drugs within 3 months prior to screening
- Currently institutionalized by regulatory or legal order
- Deemed unsuitable for participation by investigator for medical or compliance reasons
- Is an employee or family member of the investigator or site staff
- Involved in situations raising ethics concerns during study
- Has hypersensitivity to efanesoctocog alfa or its components contraindicating participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 13 locations
1
Orthopedic Institute for Children- Site Number : 8400009
Los Angeles, California, United States, 90007
Actively Recruiting
2
Innovative Hematology, Inc.- Site Number : 8400006
Indianapolis, Indiana, United States, 46260
Actively Recruiting
3
University of Iowa- Site Number : 8400004
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Ohio State University Hospital East- Site Number : 8400001
Columbus, Ohio, United States, 43203-1779
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5
Investigational Site Number : 1240003
Hamilton, Ontario, Canada, L8N 3Z5
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6
Investigational Site Number : 1240004
Hamilton, Ontario, Canada, L8N 3Z5
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7
Investigational Site Number : 3920003
Kawasaki, Kanagawa, Japan, 216-8511
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8
Investigational Site Number : 3920002
Hiroshima, Japan, 734-8551
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9
Investigational Site Number : 3920001
Saitama, Japan, 330-8777
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10
Investigational Site Number : 3920004
Tokyo, Japan, 160-0023
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11
Investigational Site Number : 1580003
Kaohsiung City, Taiwan, 80756
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12
Investigational Site Number : 1580001
Taichung, Taiwan, 407
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13
Investigational Site Number : 1580002
Taipei, Taiwan, 114
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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