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

Part of paid clinical trials in Sheffield, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07015905
Phase
PHASE3
Status
Recruiting
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Conditions

  • Venous Thromboembolism (VTE)

Eligibility Criteria

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

Interventions

  • REGN7508 — DRUG
    Administered per the protocol
  • Apixaban — DRUG
    Administered per the protocol
  • Enoxaparin — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol

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 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)

Key Dates

Start date
Jun 25, 2025
Status verified
May 2026
Primary completion
Feb 20, 2027
Completion
May 12, 2027

Study Design

Enrollment
2,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IV REGN7508
  • Experimental: IV Placebo, SC REGN7508
  • Active Comparator: IV Placebo, apixaban
  • Active Comparator: IV Placebo, enoxaparin

Primary Outcome Measure

Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death] [ Time Frame: Through day 12 visit, approximately 14 days ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Shoals Medical Trials, Inc.SheffieldAlabama35660-
CARI Clinical TrialsRiversideCalifornia92504-
Denver Metro Orthopedics, P.C. Englewood LocationEnglewoodColorado80113-
Delray Physician Care CenterDelray BeachFlorida33445-
Bioresearch PartnerMiamiFlorida33175-
Sacred Heart Health System IncPensacolaFlorida32504-
Gulfcoast Research InstituteSarasotaFlorida34232-
Phoenix Clinical ResearchTamaracFlorida33321-
Sinai Hospital of Baltimore, Inc.BaltimoreMaryland21215-
Brigham and Women's HospitalBostonMassachusetts02115-
Curalta Clinical TrialsWestwoodNew Jersey07675-
Duke University Health System (Duke Health), Duke University HospitalDurhamNorth Carolina27710-
Keystone Clinical Studies LLC, dba Flourish ResearchPlymouth MeetingPennsylvania19462-
HD Research - First Surgical HospitalBellaireTexas77401-
University of Texas (UT); Southwestern Medical CenterDallasTexas75390-
NextStage Clinical Research, All American Orthopedics and Sports MedicineHoustonTexas77058-
Futuro Clinical TrialsMcAllenTexas78501-
Flourish Research - San Antonio (Formerly Clinical Trials of Texas)San AntonioTexas78229-
DRx Clinical Research, LLCSt. GeorgeUtah84770-

Find similar trials in Sheffield, AL

By research site
Shoals Medical Trials, Inc.· Sheffield, ALCARI Clinical Trials· Riverside, CADenver Metro Orthopedics, P.C. Englewood Location· Englewood, CODelray Physician Care Center· Delray Beach, FLBioresearch Partner· Miami, FLSacred Heart Health System Inc· Pensacola, FL

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