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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.

Age: 60Years - 80YearsAll GendersPhase 2
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