ROXI-CATH
Research type
Research Study
Full 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)
IRAS ID
1009761
Contact name
Lori Khrimian
Contact email
Sponsor organisation
Regeneron Pharmaceuticals Inc.
Clinicaltrials.gov Identifier
Research 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).
This is a phase 2, randomized, double-blind, placebo-controlled trial. Randomized means that the treatment each participant receives will be randomly assigned by a computer program. Double-blind means none of the participants, researchers, trial doctors, or other trial staff know which study treatment each participant is receiving. Placebo-controlled means that some participants will receive a placebo
Participants will have an equal chance of receiving REGN9933, REGN7508, or a placebo. The duration of the study for a participant is approximately 100 days, excluding the screening period.
Approx. 195 adult participants will take part in the study across 6 countries, with approx. 6 sites expected in the UK.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0169
Date of REC Opinion
1 Jul 2024
REC opinion
Further Information Favourable Opinion