REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults

Phase 3RecruitingNCT07015905

Regeneron Pharmaceuticals2,000 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

2,000

Conditions

Venous Thromboembolism (VTE)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol 3. Body weight ≤130 kg at screening visit as described in the protocol Key Exclusion Criteria: 1. 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 2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol 3. History of thromboembolic disease or thrombophilia 4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization 5. 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

Locations (33)

Shoals Medical Trials, Inc.

Sheffield, Alabama, United States

RECRUITING

CARI Clinical Trials

Riverside, California, United States

RECRUITING

Denver Metro Orthopedics, P.C. Englewood Location

Englewood, Colorado, United States

RECRUITING

Delray Physician Care Center

Delray Beach, Florida, United States

Outcomes

Primary Outcomes

Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]