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A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA
Sponsor: Sirius Therapeutics Co., Ltd.
Summary
This is a Phase 2, multicenter, randomized, open-label, parallel group, blinded endpoint evaluation, active-controlled, dose-finding study.This study is designed to compare the efficacy and safety of 3 dose levels of SRSD107 and enoxaparin 40 mg daily in subjects undergoing elective primary unilateral TKA.
Official title: A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active Controlled Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing Elective Primary Unilateral Total Knee Arthroplasty
Key Details
Gender
All
Age Range
60 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2025-09-16
Completion Date
2026-10-31
Last Updated
2026-01-15
Healthy Volunteers
No
Conditions
Interventions
SRSD107
SRSD107 is an investigational siRNA product for anticoagulants.
enoxaparin
Enoxaparin is a low molecular weight heparin \[LMWH\] indicated for Prophylaxis of deep vein thrombosis (DVT) in abdominal surgery, hip replacement surgery, knee replacement surgery, or medical patients with severely restricted mobility during acute illness.
Locations (1)
Hospital Nové Město na Moravě
Nové Město na Moravě, Czechia