Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT
NCT07498517 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2026-03-27
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.
Conditions
Interventions
- DRUG
-
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
Sponsors & Collaborators
-
National Heart, Lung, and Blood Institute (NHLBI)
collaborator NIH -
Oregon Health and Science University
collaborator OTHER -
OHSU Knight Cancer Institute
lead OTHER
Principal Investigators
-
Joseph Shatzel, M.D. · OHSU Knight Cancer Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-02-28
- Primary Completion
- 2029-02-02
- Completion
- 2029-10-02
- FDA Drug
- Yes
Countries
- United States
Study Locations
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