Actively Recruiting
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
Led by Sirius Therapeutics Co., Ltd. · Updated on 2026-01-15
450
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of three different dose levels of SRSD107 compared to enoxaparin 40 mg daily in adults aged 60 to 80 undergoing elective primary unilateral total knee arthroplasty TKA. This Phase 2, multicenter, randomized, open-label study includes a blinded endpoint evaluation and aims to find the best dose of SRSD107 for preventing venous thromboembolism VTE after surgery. Participants will be assigned to one of four groups low, medium, or high single subcutaneous doses of SRSD107, or enoxaparin 40 mg subcutaneously once daily for 12 2 days after surgery. The identity of the study drug is known, but the specific SRSD107 dose is blinded. Up to approximately 450 subjects will be randomized to these groups. During the study, participants will take the study drug at least 28 days before surgery and attend clinic visits, including venography 10 to 14 days after TKA. Researchers will monitor the incidence of total VTE events from surgery through 12 2 days post-surgery as the primary outcome. Secondary outcomes include major VTE, bleeding events, and adverse events up to Day 169. Safety and efficacy assessments will continue throughout the study period, which ends in October 2026.
CONDITIONS
Brief Title
A Study to Compare the Efficacy and Safety of SRSD107 and Enoxaparin in Adult Subjects Undergoing TKA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 total knee arthroplasty under general anesthesia
- Willing to comply with study requirements including taking study drug at least 28 days prior to surgery, clinic visits, and venography at 10-14 days post surgery
- aPTT, PT, and INR within normal reference range at screening
You will not qualify if you...
- Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening
- Known bleeding disorder or history of increased bleeding tendency contraindicating anticoagulation
- History of intracranial, intraspinal, or intraocular bleeding
- Evidence of active cancer or history of malignancy within 2 years prior to screening
- Recent myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke, transient ischemic attack, systemic embolism, valvular thrombosis, or splanchnic thrombosis within 6 months prior to screening
- Uncontrolled blood pressure at screening
- Estimated glomerular filtration rate below 45 mL/min/1.73m2
- Liver dysfunction, cirrhosis, hepatic encephalopathy, esophageal varices, or portocaval shunt
- Clinically significant anemia at screening
- Platelet count below 100,000/m3 or history of heparin-induced thrombocytopenia
- Positive test for HIV, hepatitis B surface antigen, or active hepatitis C at screening
- Ongoing or anticipated need for anticoagulation or antiplatelet therapy from 7 days before surgery through end of study
- Participation in another interventional clinical study within 5 half-lives of investigational drug or 30 days prior to screening
- Use of any antisense oligonucleotide or siRNA products within 1 year prior to screening
- Recent or current alcoholism or recreational drug abuse
- History of hypersensitivity to study drugs or related compounds
- Unable to undergo venography due to allergy, poor venous access, impaired renal function, or other reasons
- Anticipated elective surgery during the study period
- Any condition affecting ability to comply with study drug administration or procedures as judged by investigator
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