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RECRUITING
NCT07140523
PHASE2

A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA

Sponsor: Sirius Therapeutics Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

SRSD107

SRSD107 is an investigational siRNA product for anticoagulants.

DRUG

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