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A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
Sponsor: Regeneron Pharmaceuticals
Summary
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)
Official title: A Master Protocol for a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of REGN9933 and REGN7508, Monoclonal Antibodies Against Factor XI for Prevention of Venous Thromboembolism in Patients With a Peripherally Inserted Central Catheter (ROXI-CATH)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
195
Start Date
2024-09-20
Completion Date
2026-06-01
Last Updated
2026-01-12
Healthy Volunteers
No
Conditions
Interventions
REGN9933
Intravenous (IV) single dose administered
REGN7508
IV single dose administered
Placebo
IV single dose administered
Locations (23)
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
University Health Network
Toronto, Ontario, Canada
Shaare Zedek Medical Center
Jerusalem, Jerusalem, Israel
Soroka University Medical Center
Beersheba, Southern District, Israel
Hadassah University Medical Center
Jerusalem, Israel
Lanadio Medical Center
Netanya, Israel
Rabin Medical Center
Petah Tikva, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Arensia Research Clinic
Bucharest, Romania
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
Cluj-Napoca, Romania
University hospital Southampton
Southampton, Hampshire, United Kingdom
Cardiff and Vale University Health Board - University Hospital Wales
Cardiff, Wales, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom