Phase
Condition
Thromboembolism
Blood Clots
Venous Thromboembolism
Treatment
Enoxaparin
Apixiban
REGN9933
Clinical Study ID
Ages > 50 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 screeningperiod as described in the protocol
Exclusion
Key Exclusion Criteria:
History of bleeding in the past 6 months requiring hospitalization or transfusion;history of intracranial or intraocular bleeding, excessive operative orpost-operative bleeding, and traumatic spinal or epidural anesthesia; history ofbleeding diathesis.
History of thromboembolic disease or thrombophilia
History of major surgery, including brain, spinal, or ocular, within approximatelythe 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 estimatedglomerular filtration rate as described in the protocol
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Study Design
Connect with a study center
Ziekenhuis Oost-Limburg- Campus Sint-Jan
Genk, Limburg 3600
BelgiumSite Not Available
MBAL Heart and Brain Hospital
Pleven, 5800
BulgariaSite Not Available
UMHAT St. Georgi EAD
Plovdiv, 4002
BulgariaSite Not Available
Durham Bone and Join Specialists
Ajax, Ontario L1S 7K7
CanadaActive - Recruiting
Durham Bone and Joint Specialists
Ajax, Ontario L1S 7K7
CanadaSite Not Available
Hamilton Health Sciences, Juravinski Hospital
Hamilton, Ontario L8V 1C3
CanadaSite Not Available
MAV Korhaz es Rendelointezet Szolnok
Szolnok, Jász-Nagykun-Szolnok 5000
HungarySite Not Available
Budai Irgalmasrendi Korhaz
Budapest, 1027
HungarySite Not Available
Department of Orthopedics, Somogy County Mór Kaposi Teaching Hospital
Kaposvar, 7400
HungarySite Not Available
Rambam Health Care Campus - Internal Medicine
Haifa, 3109601
IsraelSite Not Available
Meir Medical Center
Kfar-Saba, 44281
IsraelSite Not Available
Beilinson Medical Center
Petach Tikva, 4941492
IsraelSite Not Available
Liepaja Regional Hospital
Liepaja, LV3414
LatviaSite Not Available
Hospital of Traumatology and Orthopaedics
Riga, LV1005
LatviaSite Not Available
Riga's 2nd Hospital
Riga, LV-1004
LatviaSite Not Available
Vidzemes Hospital
Riga, LV-1002
LatviaSite Not Available
Lietuvos Sveikatos Mokslu Universiteto Ligonine Kauno Klinik
Kaunas, Kauno Apskritis LT-50009
LithuaniaSite Not Available
Klaipeda University Hospital
Klaipeda, Klaipedos Apskritis LT-92288
LithuaniaSite Not Available
Kaunas Clinical Hospital
Kaunas, LT-44320
LithuaniaActive - Recruiting
Lietuvos Sveikatos Mokslu Universiteto Kauno Ligoninė
Kaunas, LT-44320
LithuaniaSite Not Available
Specjalistyczny Szpital im. E. Szczeklika w Tarnowie
Tarnow, Malopolskie 33-100
PolandSite Not Available
SP ZOZ Centralny Szpital Kliniczny UM w Lodzi
Lodz, 90-153
PolandSite Not Available
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, 20-954
PolandSite Not Available
Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Radzyniu Podlaskim
Radzyn Podlaski, 21-300
PolandSite Not Available
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