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

Recruiting Phase 2 Interventional Study
Venous Thromboembolism
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
60 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
450 (estimated)
Sponsor
Sirius Therapeutics Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Able to provide written informed consent before any study assessment is performed. 2. Male and female subjects, of any race, between 60 and 80 years of age, inclusive. 3. Body mass index between 18.0 and 35.0 kg/m2, inclusive. 4. Eligible to undergo elective primary unilatera…
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