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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT07498517
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Thrombosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Mar 2026
Primary completion
Feb 2, 2029
Completion
Oct 2, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Arm A: Placebo
    Placebo
  • Experimental: Arm B: Gruticibart
    Gruiticibart

Primary Outcome Measure

Number of participants with catheter-related thrombosis [ Time Frame: Day 1 to end of follow up (up to 14 days) ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239
Joseph Shatzel, M.D.
[email protected]
503-494-6594
Joseph Shatzel, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
OHSU Knight Cancer Institute· Portland, OR

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