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.
Able to provide written informed consent before any study assessment is performed.
Male and female subjects, of any race, between 60 and 80 years of age, inclusive.
Body mass index between 18.0 and 35.0 kg/m2, inclusive.
Eligible to undergo elective primary unilateral TKA under general anesthesia.
Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
Known bleeding disorder; history of increased bleeding tendency or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.
History of intracranial, intraspinal, or intraocular bleeding.
Evidence of active cancer, or a history of malignancy, within 2 years prior to screening.
Parallel
SRSD107
DrugSRSD107 is an investigational siRNA product for anticoagulants.
enoxaparin
DrugEnoxaparin 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.
Incidence of total venous thromboembolism (VTE) events
Defined as deep vein thrombosis (DVT) (asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic), non-fatal and fatal PE, and unexplained death for which PE cannot be excluded.
Incidence of major VTE
Defined as objectively confirmed symptomatic DVT and PE, asymptomatic proximal DVT (confirmed by venogram), fatal PE, and unexplained death for which PE cannot be excluded.
Incidence of total VTE events
Defined as symptomatic DVT, asymptomatic DVT (confirmed by venogram), non-fatal and fatal PE, unexplained death for which PE cannot be excluded.
Incidence of total VTE events for each individual dosing cohort of SRSD107 compared to enoxaparin
Defined as symptomatic DVT, asymptomatic DVT (confirmed by venogram), non-fatal and fatal PE, unexplained death for which PE cannot be excluded.
Incidence of composite of major bleeding (MB) and clinically relevant non-major bleeding (CRNMB)
Based on the 2013 Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery (EMA/CHMP/325170/2012), as well as updated guidance from the International Society of Thrombosis and Haemostasis (ISTH; Schulman 2010).
Click on the lead sponsor to view all of their trials.
