Symptomatic Venous Thromboembolism (VTE)
Conditions
Keywords
Total Knee Arthroplasty (TKA), Elective Unilateral TKA, Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE)
Brief summary
This study is researching an experimental drug called REGN7508 versus Acetylsalicylic Acid (ASA) (each called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement 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 total knee replacement surgery compared to acetylsalicylic acid. 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 study drug less effective or could lead to side effects)
Interventions
DRUGREGN7508
Administered per the protocol
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol Key
Exclusion criteria
1. 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 2. History of bleeding in the 6 months prior to randomization 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 (eg, hemophilia A or B, von Willebrand's Factor deficiency) 3. History of thromboembolic disease or thrombophilia 4. History of platelet dysfunction 5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of the composite endpoint of symptomatic VTE and VTE-related death | Through day 30 visit |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT) | Through day 30 visit |
| Incidence of confirmed Pulmonary Embolism (PE) | Through day 30 visit |
| Incidence of VTE-related death | Through day 30 visit |
| Time to first event of the composite endpoint of symptomatic VTE and VTE-related death | Through day 30 visit |
| Time to first event of confirmed symptomatic DVT | Through day 30 visit |
| Time to first event of confirmed PE | Through day 30 visit |
| Time to VTE-related death | Through day 30 visit |
| Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding | Through day 30 visit |
| Incidence of minor bleeding | Through day 30 visit |
| Incidence of Treatment-Emergent Adverse Events (TEAEs) | Through day 90 visit |
| Severity of TEAEs | Through day 90 visit |
| Incidence of Anti-drug Antibody (ADA) to REGN7508 | Through day 90 visit |
| Magnitude of ADA to REGN7508 | Through day 90 visit |
| Concentrations of REGN7508 | Through day 90 visit |
Countries
United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed