A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
- Registration Number
- NCT06454630
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 179
- Undergoing a primary elective unilateral TKA
- Has a body weight โค130 kg at screening visit
- Is judged by the investigator to be in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECG's) performed at screening and/or prior to administration of initial dose of study drug as described in the protocol
- Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol
Key
- History of bleeding in the past 6 months prior to dosing requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis
- History of thromboembolic disease or thrombophilia
- History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months
- History of major trauma within approximately the past 6 months prior to dosing
- Hospitalized (>24 hours) for any reason within 30 days of the screening visit
- Has an estimated glomerular filtration rate (GFR) of <45 mL/min/1.73m^2 at the screening visit using one of the following formulas: the Modification of Diet in Renal Disease (MDRD) equation, the Chronic Kidney Disease Epidemiology Collaboration equation, or equivalent equation
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description REGN7508 REGN7508 - Enoxaparin Enoxaparin -
- Primary Outcome Measures
Name Time Method Incidence of confirmed, adjudicated VTE Through day 12
- Secondary Outcome Measures
Name Time Method Incidence of major bleeding Up to approximately Day 12 Incidence of clinically relevant non-major (CRNM) bleeding Up to approximately Day 12 Incidence of treatment emergent adverse events (TEAEs) Through end of study; approximately Day 75 Incidence of major VTE Through day 12 Incidence of Deep venous thrombosis (DVT) Approximately Day 12 Concentrations of REGN7508 in serum Through end of study; approximately Day 75 Change in activated partial thromboplastin time (aPTT) Baseline to end of study; approximately Day 75 Change in prothrombin time (PT) Baseline to end of study; approximately Day 75 Incidence of anti-drug antibodies (ADA) to REGN7508 Through end of study; approximately Day 75 Titer of ADA to REGN7508 Through end of study; approximately Day 75
Trial Locations
- Locations (14)
Multi-profile Hospital for Active Treatment Hearth and Brain EAD
๐ง๐ฌPleven, Bulgaria
Multiprofile Hospital For Active Treatment Park Hospital Ltd.
๐ง๐ฌPlovdiv, Bulgaria
Budai Irgalmasrendi Korhaz
๐ญ๐บBudapest, Hungary
Szolnoki MAV Hospital
๐ญ๐บSzolnok, Hungary
Vidzemes Hospital
๐ฑ๐ปValmiera, Valmieras Aprinkis, Latvia
Liepaja Regional Hospital
๐ฑ๐ปLiepaja, Latvia
Riga's 2nd Hospital
๐ฑ๐ปRiga, Latvia
Hospital of Traumatology and Orthopaedics
๐ฑ๐ปRiga, Latvia
Orto Klinika
๐ฑ๐ปRiga, Latvia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinik
๐ฑ๐นKaunas, Kauno Apskritis, Lithuania
Lithuanian University of Health Sciences Kaunas Hospital
๐ฑ๐นKaunas, Lithuania
Klaipeda University Hospital
๐ฑ๐นKlaipeda, Lithuania
Specjalistyczny Szpital im. E. Szczeklika w Tarnowie
๐ต๐ฑTarnow, Malopolskie, Poland
Clinic of Orthopaedics and Paediatric Orthopaedics
๐ต๐ฑLodz, ลรณdzkie, Poland