REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
- Conditions
- Venous Thromboembolism (VTE)
- Interventions
- Registration Number
- NCT07015905
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.
The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related diseases after total knee replacement surgery.
The study is looking at several other research questions, including:
* What side effects may happen from taking the study drug
* How much study drug is in the blood at different times
* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2000
- Is undergoing a primary elective unilateral TKA
- Is in good health based on laboratory safety testing as described in the protocol
- Body weight ≤130 kg at screening visit as described in the protocol
Key
- Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation
- History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol
- History of thromboembolic disease or thrombophilia
- History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization
- Has an estimated Glomerular Filtration Rate (GFR) of <30 mL/min/1.73 m2 at the screening visit as described in the protocol
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IV Placebo, enoxaparin Enoxaparin - IV Placebo, enoxaparin Placebo - IV REGN7508 REGN7508 - IV Placebo, SC REGN7508 REGN7508 - IV Placebo, SC REGN7508 Placebo - IV Placebo, apixaban Apixaban - IV Placebo, apixaban Placebo -
- Primary Outcome Measures
Name Time Method Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death] Through day 12 visit, approximately 14 days
- Secondary Outcome Measures
Name Time Method Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT) Through day 12 visit, approximately 14 days Incidence of confirmed Pulmonary Embolism (PE) Through day 12 visit, approximately 14 days Incidence of VTE-related death Through day 12 visit, approximately 14 days Incidence of the composite endpoint of major and clinically relevant non-major (CRNM) bleeding Through day 12 visit, approximately 14 days Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) Through day 12 visit, approximately 14 days Incidence of minor bleeding Through day 12 visit, approximately 14 days Incidence of Treatment Emergent Adverse Events (TEAEs) Approximately day 90 Incidence of Anti-Drug Antibodies (ADA) to REGN7508 Approximately day 90 Titer of ADA to REGN7508 Approximately day 90 Concentrations of REGN7508 Approximately day 90
Related Research Topics
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Trial Locations
- Locations (1)
Phoenix Clinical Research
🇺🇸Tamarac, Florida, United States
Phoenix Clinical Research🇺🇸Tamarac, Florida, United States