Comparing SRSD107 and enoxaparin to prevent clots after total knee replacement

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

It will test whether three dose levels of an experimental drug, SRSD107, work as well and are as safe as daily enoxaparin for preventing blood clots in adults aged 60–80 having elective primary unilateral total knee replacement.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 60 Years to 80 Years
• Sex: All
• Sponsor: Sirius Therapeutics Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Nové Město na Moravě)
• Trial ID: NCT07140523 on ClinicalTrials.gov

What this trial studies

This phase 2, multicenter, randomized, open-label, parallel-group study uses blinded endpoint evaluation to compare three dose levels of SRSD107 with enoxaparin 40 mg daily for venous thromboembolism prevention after elective primary unilateral total knee arthroplasty (TKA). Approximately 450 adults aged 60–80 with BMI 18–35 kg/m2 will be randomized to one of the SRSD107 dose groups or the enoxaparin arm, with the specific SRSD107 dose blinded while the drug identity is unblinded. Participants will take study medication around the time of surgery and undergo venography 10–14 days after TKA to detect deep vein thrombosis, with efficacy and safety outcomes compared across groups. Key eligibility includes normal coagulation tests and the ability to comply with clinic visits and imaging; major exclusions include recent major bleeding, bleeding disorders, and recent malignancy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 60–80 undergoing elective primary unilateral TKA with BMI 18–35 kg/m2, normal clotting tests, and willingness to attend study visits and venography.

Not a fit: Patients with recent major bleeding, known bleeding disorders, recent intracranial or intraocular hemorrhage, active cancer within two years, or other contraindications to prophylactic anticoagulation are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, SRSD107 could provide an effective alternative to enoxaparin for preventing post-operative blood clots, potentially offering different dosing or safety advantages.

How similar studies have performed: Enoxaparin is an established effective prophylactic option after TKA, while SRSD107 is experimental and dose-finding studies of this specific agent are novel.

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 unilateral TKA under general anesthesia.
5. Willing to comply with study requirements including taking study drug at least 28 days prior to TKA, clinic visits, and venography at 10-14 days post TKA.
6. aPTT, PT, and INR within the normal reference range at screening.

Exclusion Criteria:

1. Active bleeding requiring medical or surgical intervention within 4 weeks prior to screening.
2. Known bleeding disorder; history of increased bleeding tendency or any other condition that in the opinion of the investigator contraindicates prophylactic anticoagulation.
3. History of intracranial, intraspinal, or intraocular bleeding.
4. Evidence of active cancer, or a history of malignancy, within 2 years prior to screening.
5. Myocardial infarction, DVT, PE, stroke , transient ischemic attack, systemic embolism, valvular thrombosis, or splanchnic thrombosis in the 6 months prior to screening.
6. Uncontrolled blood pressure at the time of screening.
7. Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73m2.
8. Liver dysfunction, liver cirrhosis, history of hepatic encephalopathy, esophageal varices, or portocaval shunt.
9. Clinically significant anemia at screening.
10. Platelet counts \<100,000/m3 at screening or a history of heparin-induced thrombocytopenia.
11. Positive test for human immunodeficiency virus (HIV) , positive hepatitis B surface antigen, and/or active hepatitis C at screening.
12. Ongoing or anticipated need for anticoagulation or antiplatelet therapy from 7 days prior to surgery through the EoS visit.
13. Participation in an interventional clinical study within 5 half-lives of the investigational drug or 30 days prior to screening, whichever is longer.
14. Use of any ASO or siRNA products within 1 year prior to screening. Diet and Lifestyle.
15. Recent or current history of alcoholism or recreational drug abuse.
16. History of hypersensitivity to any of the study drugs or its excipients, to drugs of similar chemical classes or drugs issued from the same biologic origin or any contraindication listed in the label for enoxaparin.
17. Unable to undergo venography due to a known allergy to the contrast agent, anticipated poor venous access, impaired renal function, or any other reason identified and specified by the investigator.
18. Anticipated elective surgery during the study period.
19. Any other condition or circumstance that would affect the subject's ability to be compliant with study drug administration or study procedures, in the opinion of the investigator.

Where this trial is running

Nové Město na Moravě

• Hospital Nové Město na Moravě — Nové Město na Moravě, Czechia (Recruiting)

Conditions Venous Thromboembolism