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ACTIVE NOT RECRUITING
NCT06299111
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

REGN9933

Intravenous (IV) single dose administered

DRUG

REGN7508

IV single dose administered

DRUG

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