Venous Thromboembolism (VTE)
Conditions
Keywords
Unilateral Total Knee Arthroplasty (TKA), Factor XI (FXI)
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 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. 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
DRUGApixaban
Administered per the protocol
DRUGEnoxaparin
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (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 3. Body weight ≤130 kg at screening visit 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 as described in the protocol 3. History of thromboembolic disease or thrombophilia 4. History of major surgery, including brain, spinal, or ocular, or major trauma within approximately the past 6 months prior to randomization 5. Has an estimated Glomerular Filtration Rate (GFR) of \<30 mL/min/1.73 m2 at the screening visit as described in the protocol Note: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of the composite endpoint of asymptomatic or symptomatic Venous Thromboembolism (VTE) [including VTE-related death] | Through day 12 visit, approximately 14 days |
Secondary
| Measure | Time frame |
|---|---|
| Time-to-first event of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) | Through day 12 visit, approximately 14 days |
| Incidence of confirmed symptomatic Deep Venous Thrombosis (DVT) | Through day 12 visit, approximately 14 days |
| Incidence of confirmed Pulmonary Embolism (PE) | Through day 12 visit, approximately 14 days |
| Incidence of VTE-related death | Through day 12 visit, approximately 14 days |
| Time-to-first event of confirmed symptomatic DVT | Through day 12 visit, approximately 14 days |
| Time-to-first event of confirmed PE | Through day 12 visit, approximately 14 days |
| Time to VTE-related death | Through day 12 visit, approximately 14 days |
| Incidence of the composite endpoint of major and Clinically Relevant Non-Major (CRNM) bleeding | Through day 12 visit, approximately 14 days |
| Incidence of the composite endpoint of asymptomatic or symptomatic VTE (including VTE-related death) | Through day 12 visit, approximately 14 days |
| Incidence of minor bleeding | Through day 12 visit, approximately 14 days |
| Incidence of Treatment Emergent Adverse Events (TEAEs) | Approximately day 90 |
| Occurrence of Anti-Drug Antibodies (ADA) to REGN7508 | Approximately day 90 |
| Magnitude of ADA to REGN7508 | Approximately day 90 |
| Concentrations of REGN7508 | Approximately day 90 |
Countries
Bulgaria, Hungary, Japan, Latvia, Lithuania, Poland, United States
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed