A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
NCT06454630 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 179
Last updated 2026-03-02
Summary
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)
Conditions
- Venous Thromboembolism
Interventions
- DRUG
-
REGN7508
Administered by single intravenous (IV) dose
- DRUG
-
Enoxaparin
Administered by subcutaneous (SC) dose daily through the time of venography (or day 12, whichever is earlier)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trial Management · Regeneron Pharmaceuticals
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-27
- Primary Completion
- 2024-11-19
- Completion
- 2025-01-21
- FDA Drug
- Yes
Countries
- Bulgaria
- Hungary
- Latvia
- Lithuania
- Poland
Study Locations
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