Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy
Recruiting now Phase 4 NCT06941870
Run by Sanofi · for 12 and older · All sexes
What this study 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.
Who can join (things the study team will check)
Inclusion Criteria: Participant is diagnosed with moderate to severe hemophilia A (defined as less than or equal to (≤)5 percent (%) of endogenous FVIII clotting activity) at the time of consent/assent. Participant is more than or equal to (≥)12 years old at the time of consent/assent. Participant has existing synovial hypertrophy, defined as at least 1 eligible\* joint by the HEAD-US score (Synovitis score: 1 or 2) at the time of consent/assent. Participant has at least 1 eligible\* joint without planned future major orthopedic procedures (example, arthroscopic synovectomy, radioisotopic or chemical synoviorthesis), or major orthopedic procedures in the past 3 months prior to the screening visit (Visit 1). \*An eligible joint is a joint with existing synovial hypertrophy, as defined by a HEAD-US synovitis score of 1 or 2, considering hypertrophic synovium as an indication of the presence of synovitis Participant has received prophylactic treatment with hemophilia prophylaxis prescriptions in the last 12 months prior to the baseline visit (Visit 2). Participant is capable of understanding the written Informed Consent Form (ICF)/assent form, provides a signed and witnessed writ…
Where this trial is running
- Orthopedic Institute for Children- Site Number : 8400009, Los Angeles, California, United States
- Innovative Hematology, Inc.- Site Number : 8400006, Indianapolis, Indiana, United States
- University of Iowa- Site Number : 8400004, Iowa City, Iowa, United States
- Ohio State University Hospital East- Site Number : 8400001, Columbus, Ohio, United States
- Investigational Site Number : 1240003, Hamilton, Ontario, Canada
- Investigational Site Number : 1240004, Hamilton, Ontario, Canada
- Investigational Site Number : 3920003, Kawasaki, Kanagawa, Japan
- Investigational Site Number : 3920002, Hiroshima, Japan
- Investigational Site Number : 3920001, Saitama, Japan
- Investigational Site Number : 3920004, Tokyo, Japan
- Investigational Site Number : 1580003, Kaohsiung City, Taiwan
- Investigational Site Number : 1580001, Taichung, Taiwan
+ 1 more sites.
Who to contact
Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · Contact-US@sanofi.com
It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06941870.
Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.