Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy

Part of paid clinical trials in Los Angeles, California.

Sponsor
Sanofi
Study ID
NCT06941870
Phase
PHASE4
Status
Recruiting
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Conditions

  • Factor VIII Deficiency

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Efanesoctocog alfa — DRUG
    Pharmaceutical form:Lyophilized powder in a sterile vial that requires reconstitution with sterile water for injection (diluent)-Route of administration:Intravenous

Study Details

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.

Key Dates

Start date
Sep 23, 2025
Status verified
Nov 2025
Primary completion
Oct 25, 2027
Completion
Oct 25, 2027

Study Design

Enrollment
35 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Efanesoctocog Alfa
    Participants will receive Efanesoctocog Alfa at 50 international unit per kilogram (IU/kg) intravenous (IV) QW

Primary Outcome Measure

Proportion of joints with improvement in the Hemophilia Early Arthropathy Detection with Ultrasound (HEAD-US) synovitis domain score [ Time Frame: From Baseline up to Week 52 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (4)

FacilityCityStateZIPSite coordinators
Orthopedic Institute for Children- Site Number : 8400009Los AngelesCalifornia90007-
Innovative Hematology, Inc.- Site Number : 8400006IndianapolisIndiana46260-
University of Iowa- Site Number : 8400004Iowa CityIowa52242-
Ohio State University Hospital East- Site Number : 8400001ColumbusOhio43203-1779-

Find similar trials in Los Angeles, CA

By research site
Orthopedic Institute for Children· Los Angeles, CAInnovative Hematology, Inc.· Indianapolis, INUniversity of Iowa· Iowa City, IAOhio State University Hospital East· Columbus, OH

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