RECRUITING

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

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Conditions

Venous Thromboembolism (VTE)Unilateral Total Knee Arthroplasty (TKA)Factor XI (FXI)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

A Phase 3, Multicenter, Randomized, Open-Label, Sponsor-Blinded, Study to Evaluate REGN7508, A Factor XI Monoclonal Antibody, Versus Apixaban and Enoxaparin for Prophylaxis of Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-APEX)

Quick Facts

Study Start:2025-06-25
Study Completion:2027-05-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07015905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Is undergoing a primary elective unilateral TKA
  2. 2. Is in good health based on laboratory safety testing as described in the protocol
  3. 3. Body weight ≤130 kg at screening visit as described in the protocol
  1. 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. 2. History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol
  3. 3. History of thromboembolic disease or thrombophilia
  4. 4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization
  5. 5. Has an estimated Glomerular Filtration Rate (GFR) of \<30 mL/min/1.73 m2 at the screening visit as described in the protocol

Contacts and Locations

Study Contact

Clinical Trials Administrator
CONTACT
844-734-6643
clinicaltrials@regeneron.com

Principal Investigator

Clinical Trial Management
STUDY_DIRECTOR
Regeneron Pharmaceuticals

Study Locations (Sites)

Phoenix Clinical Research
Tamarac, Florida, 33321-2902
United States

Collaborators and Investigators

Sponsor: Regeneron Pharmaceuticals

  • Clinical Trial Management, STUDY_DIRECTOR, Regeneron Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-25
Study Completion Date2027-05-12

Study Record Updates

Study Start Date2025-06-25
Study Completion Date2027-05-12

Terms related to this study

Keywords Provided by Researchers

  • Unilateral Total Knee Arthroplasty (TKA)
  • Factor XI (FXI)

Additional Relevant MeSH Terms

  • Venous Thromboembolism (VTE)