Venous Thromboembolism (VTE) Clinical Trials

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A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This study is researching an experimental drug called REGN7508 (called study drug) and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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 compared to acetylsalicylic acid. 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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Is undergoing a primary elective unilateral TKA

• Is in good health based on laboratory safety testing as described in the protocol

Locations
United States
California
Eisenhower Medical Center
RECRUITING
Rancho Mirage
Colorado
Sky Ridge Medical Center
RECRUITING
Lone Tree
Florida
Medical Research of Westchester - MPLUS Research Network
RECRUITING
Miami
Phoenix Clinical Research
RECRUITING
Tamarac
Illinois
Endeavor Health
RECRUITING
Skokie
Indiana
The Orthopaedic Research Foundation, Inc.
RECRUITING
Indianapolis
Kansas
NextStage Clinical Research, St. Francis Medical Park
RECRUITING
Wichita
Maryland
Velocity Clinical Research, Annapolis
RECRUITING
Annapolis
Sinai Hospital of Baltimore, Inc.
RECRUITING
Baltimore
North Carolina
Eximia Equihealth Research-Raleigh. LLC
RECRUITING
Raleigh
The Vein and Vascular Center at Raleigh Radiology
RECRUITING
Raleigh
Coastal Vascular Institute, PA
RECRUITING
Wilmington
New Jersey
Holy Name Medical Center
RECRUITING
Teaneck
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
University of Cincinnati
RECRUITING
Cincinnati
Ohio Clinical Trials
RECRUITING
Columbus
The Ohio State University Wexner Medical Center
RECRUITING
Columbus
Pennsylvania
University of Pittsburgh
RECRUITING
Pittsburgh
Texas
HD Research - Memorial Hermann Village
RECRUITING
Houston
NextStage Clinical Research, All American Orthopedics and Sports Medicine
RECRUITING
Houston
Endeavor Clinical Trials
WITHDRAWN
San Antonio
Virginia
Carilion Clinic
RECRUITING
Roanoke
Washington
Spokane Joint Replacement Center
RECRUITING
Spokane
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2025-11-24
Estimated Completion Date: 2027-07-16
Participants
Target number of participants: 2000
Treatments
Experimental: REGN7508 and Placebo
Active_comparator: Placebo and ASA
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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