A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06454630
Phase
PHASE2
Status
Completed

Conditions

  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN7508 — DRUG
    Administered by single intravenous (IV) dose
  • Enoxaparin — DRUG
    Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier)

Study Details

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 (TKR) 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 unilateral 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 drug less effective or could lead to side effects)

Key Dates

Start date
Jun 27, 2024
Status verified
May 2026
Primary completion
Nov 19, 2024
Completion
Jan 21, 2025

Study Design

Enrollment
179 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: REGN7508
  • Active Comparator: Enoxaparin

Primary Outcome Measure

Percentage of Participants With Confirmed, Adjudicated Venous Thromboembolism (VTE) [ Time Frame: Through day 12 ]

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