Synovitis Clinical Trials

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Prospective Interventional Study of Effectiveness of Efanesoctocog Alfa Prophylaxis on Synovial Hypertrophy in Patients With Hemophilia A

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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 written ICF/assent form, and agrees to comply with the protocol requirements.

• If male, no contraceptive measures are required for this study.

• If female, is not pregnant or breastfeeding, and one of the following conditions applies:

• Is a women of nonchildbearing potential (WONCBP)

• Is a WOCBP and agrees to use a highly effective contraceptive method, with a failure rate of less than (\<)1 percent during the study treatment period (at least until the Week 52/ End of Treatment \[EoT\] visit).

• A WOCBP must have a negative serum pregnancy test at the screening visit (Visit 1)

Locations
United States
California
Orthopedic Institute for Children- Site Number : 8400009
COMPLETED
Los Angeles
Iowa
University of Iowa- Site Number : 8400004
RECRUITING
Iowa City
Indiana
Indiana Hemophilia and Thrombosis Center- Site Number : 8400006
RECRUITING
Indianapolis
Ohio
The Ohio State University Wexner Medical Center - CarePoint East- Site Number : 8400001
COMPLETED
Columbus
Washington
Washington Center for Bleeding Disorders- Site Number : 8400008
RECRUITING
Seattle
Other Locations
Canada
Investigational Site Number : 1240003
RECRUITING
Hamilton
Investigational Site Number : 1240004
COMPLETED
Hamilton
Japan
Investigational Site Number : 3920002
COMPLETED
Hiroshima
Investigational Site Number : 3920003
RECRUITING
Kawasaki
Investigational Site Number : 3920001
RECRUITING
Saitama
Investigational Site Number : 3920004
COMPLETED
Tokyo
Taiwan
Investigational Site Number: 1580003
RECRUITING
Kaohsiung City
Investigational Site Number: 1580001
RECRUITING
Taichung
Investigational Site Number: 1580002
RECRUITING
Taipei
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-09-23
Estimated Completion Date: 2027-10-25
Participants
Target number of participants: 35
Treatments
Experimental: Efanesoctocog Alfa
Participants will receive Efanesoctocog Alfa at 50 international unit per kilogram (IU/kg) intravenous (IV) QW
Related Therapeutic Areas
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov