A Trial to Learn How Well REGN9933 Works for Preventing Blood Clots After Knee Replacement Surgery in Adult Participants
Venous Thromboembolism
About this trial
This is an interventional treatment trial for Venous Thromboembolism focused on measuring Anti-factor XI (FXI) monoclonal antibody, Deep Vein Thrombosis, Unilateral total knee arthroplasty (TKA),
Eligibility Criteria
Key Inclusion Criteria: Undergoing elective unilateral TKA Has a body weight ≤130 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) performed at screening and/or prior to administration of initial dose of study drug Is in good health based on laboratory safety testing obtained during the screening period as described in the protocol Key Exclusion Criteria: History of bleeding in the past 6 months 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. Hospitalized (>24 hours) for any reason within 30 days of the screening visit Using the Modification of Diet in Renal Disease equation, has an estimated glomerular filtration rate as described in the protocol Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Sites / Locations
- Ziekenhuis Oost-Limburg- Campus Sint-Jan
- MBAL Heart and Brain Hospital
- UMHAT St. Georgi EAD
- Durham Bone and Joint Specialists
- Hamilton Health Sciences, Juravinski Hospital
- MAV Korhaz es Rendelointezet Szolnok
- Budai Irgalmasrendi Korhaz
- Department of Orthopedics, Somogy County Mór Kaposi Teaching Hospital
- Rambam Health Care Campus - Internal Medicine
- Meir Medical Center
- Beilinson Medical Center
- Liepaja Regional Hospital
- Vidzemes HospitalRecruiting
- Riga's 2nd HospitalRecruiting
- Hospital of Traumatology and OrthopaedicsRecruiting
- Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno KlinikRecruiting
- Klaipeda University HospitalRecruiting
- Lietuvos Sveikatos Mokslu Universiteto Kauno LigoninėRecruiting
- Specjalistyczny Szpital im. E. Szczeklika w TarnowieRecruiting
- SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Radzyniu PodlaskimRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
REGN9933
Enoxaparin
Apixaban
REGN9933 will be administered by intravenous (IV) infusion
Enoxaparin will be administered by subcutaneous (SC) administration
Apixaban will be administered orally twice a day