Prospective Interventional Study of Effectiveness of Efanesoctocog Alfa Prophylaxis on Synovial Hypertrophy in Patients With Hemophilia A
Sanofi
Summary
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.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
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 o…
Interventions
- DrugEfanesoctocog alfa
Pharmaceutical form:Lyophilized powder in a sterile vial that requires reconstitution with sterile water for injection (diluent)-Route of administration:Intravenous
Locations (13)
- Orthopedic Institute for Children- Site Number : 8400009Los Angeles, California
- Innovative Hematology, Inc.- Site Number : 8400006Indianapolis, Indiana
- University of Iowa- Site Number : 8400004Iowa City, Iowa
- Ohio State University Hospital East- Site Number : 8400001Columbus, Ohio
- Investigational Site Number : 1240003Hamilton, Ontario
- Investigational Site Number : 1240004Hamilton, Ontario