Phase 3: testing REGN7508 for Venous Thromboembolism (VTE)
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.
Official registry: https://clinicaltrials.gov/study/NCT07015905 · Regeneron Pharmaceuticals · enrollment listed as 2,000
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are REGN7508, Apixaban, or Enoxaparin. The registry lists allocation as randomized. This study is researching an experimental drug called REGN7508 (called "study drug").
They plan to enroll about 2,000 people at 47 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Phase 3, Multicenter, Randomized, Open-Label, 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)
Interventions: REGN7508, Apixaban, Enoxaparin, Placebo
Primary outcome (registry wording): Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death]
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- Is undergoing a primary elective unilateral TKA
- Is in good health based on laboratory safety testing as described in the protocol
- Body weight ≤130 kg at screening visit as described in the protocol
Who the registry excludes
- 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
- History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion as described in the protocol
- History of thromboembolic disease or thrombophilia
- History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization
- 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/
Public study contact (from the registry)
Clinical Trials Administrator
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
47 listed- Shoals Medical Trials, Inc. — Sheffield, Alabama (recruiting)
- CARI Clinical Trials — Riverside, California (recruiting)
- Denver Metro Orthopedics, P.C. Englewood Location — Englewood, Colorado (recruiting)
- Delray Physician Care Center — Delray Beach, Florida (recruiting)
- Bioresearch Partner — Miami, Florida (recruiting)
- Sacred Heart Health System Inc — Pensacola, Florida (recruiting)
- Gulfcoast Research Institute — Sarasota, Florida (recruiting)
- Phoenix Clinical Research — Tamarac, Florida (recruiting)
- Sinai Hospital of Baltimore, Inc. — Baltimore, Maryland (recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts (recruiting)
- Curalta Clinical Trials — Westwood, New Jersey (recruiting)
- Duke University Health System (Duke Health), Duke University Hospital — Durham, North Carolina (recruiting)
+ 27 sites outside the US on the same record
FAQ about this NCT record
Is NCT07015905 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07015905?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07015905?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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