NCT07498517

Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT

A Study to Evaluate the Safety and Efficacy of a Single Dose of Gruticibart for the Prevention of Early Catheter-related Thrombosis

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well gruticibart works in reducing the incidence of catheter-related thrombosis (CRT) blood clots in patients with a central venous catheter (CVC) inserted. Many patients develop blood clots from their catheters and can have pain, swelling, and other symptoms. They also often require blood thinners, which can increase the risk of bleeding. Gruticibart, a type of drug called a monoclonal antibody, may prevent blood clots caused by a catheter.

Detailed description

PRIMARY OBJECTIVE(S): I. To determine the safety of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of gruticibart in patients with a CVC II. To determine the efficacy of gruticibart as measured by the time to CRT and incidence of any thrombosis in individuals with a CVC OUTLINE: Participants are randomized to 1 of 2 arms. Arm A. Participants receive single dose of placebo IV via CVC or peripheral IV line. Arm B. Participantsreceive single dose of gruticibart (2 mg/kg) IV via CVC or peripheral IV line. After completion of study treatment, participants will be followed for AEs for a total of 30 days from time of administration of study drug, and are considered off-study after 30 days. .

Conditions

• Thrombosis

Interventions

Type	Name	Description
DRUG	Placebo	Given IV or via catheter
DRUG	Gruticibart	2mg/kg, Given IV or via catheter
PROCEDURE	Ultrasound	Undergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )
PROCEDURE	Biopspecimen collection	Undergo blood sample collection

Timeline

• Start date: 2026-02-28
• Primary completion: 2029-02-02
• Completion: 2029-10-02
• First posted: 2026-03-27
• Last updated: 2026-03-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study