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)
Status: Recruiting
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• PICC is clinically indicated for at least 14 days and is anticipated to remain in place for at least 14 days
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2 or equivalent functional status as described in the protocol
• Body weight ≥45 kg and ≤130 kg during the screening period
• International normalized ratio (INR) and aPTT values at or below the upper limit of normal as defined by the local lab during the screening period
• Platelet count ≥100 x 10\^9/L during the screening period as described in the protocol
Locations
United States
Florida
Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
New York
Memorial Sloan Kettering
RECRUITING
New York
Mount Sinai Medical Center
RECRUITING
New York
Other Locations
Bulgaria
Sveta Sofia Hospital
RECRUITING
Sofia
Canada
London Health Sciences Centre
RECRUITING
London
Lakeridge Health
RECRUITING
Oshawa
University Health Network
RECRUITING
Toronto
Israel
Soroka University Medical Center
RECRUITING
Beersheba
Hadassah University Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Lanadio Medical Center
RECRUITING
Netanya
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Tel Aviv Sourasky Medical Center
RECRUITING
Tel Aviv
Romania
Arensia Exploratory Medicine Clinic at Country Hospital Cluj-Napoca
RECRUITING
Cluj-napoca
United Kingdom
Cardiff and Vale University Health Board - University Hospital Wales
RECRUITING
Cardiff
The Newcastle Upon Tyne Hospitals NHS Foundation Trust