This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'. The aim of the study is to see how effective the study drug is at preventing venous thromboembolism (VTE) and other related disease after catheter placement. 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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
195
Intravenous (IV) single dose administered
IV single dose administered
IV single dose administered
Cedars-Sinai Medical Center
Los Angeles, California, United States
Sylvester Comprehensive Cancer Center
Miami, Florida, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Mount Sinai Medical Center
New York, New York, United States
Memorial Sloan Kettering
New York, New York, United States
Sveta Sofia Hospital
Sofia, Bulgaria
Juravinski Hospital
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
Lakeridge Health
Oshawa, Ontario, Canada
...and 13 more locations
Incidence of confirmed VTE per central reading center (CRC) review
Time frame: Through Day 14
Incidence of treatment-emergent adverse event (TEAEs)
Time frame: Up to Day 100
Severity of TEAEs
Time frame: Up to Day 100
Incidence of confirmed PICC associated venous thrombosis per CRC review
Time frame: Through Day 14
Incidence of major bleeding
Time frame: Through Day 14
Incidence of clinically relevant non-major (CRNM) bleeding
Time frame: Through Day 14
Concentrations of REGN9933 in serum
Time frame: Up to Day 75
Concentrations of REGN7508 in serum
Time frame: Up to Day 75
Change in activated partial thromboplastin time (aPTT)
Time frame: Up to Day 75
Change in prothrombin time (PT)
Time frame: Up to Day 75
Incidence of anti-drug antibody (ADA) to REGN9933 over time
Time frame: Up to Day 75
Magnitude of ADA to REGN9933 over time
Time frame: Up to Day 75
Incidence of ADA to REGN7508 over time
Time frame: Up to Day 75
Magnitude of ADA to REGN7508 over time
Time frame: Up to Day 75
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