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
- Recruiting
Conditions
- Thrombosis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Placebo — DRUGGiven IV or via catheter
- Gruticibart — DRUG2mg/kg, Given IV or via catheter
- Ultrasound — PROCEDUREUndergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )
- Biopspecimen collection — PROCEDUREUndergo 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
- First listed
- Mar 27, 2026
- Start date
- Aug 6, 2026
- Status verified
- Aug 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: PlaceboPlacebo
- Experimental: Arm B: GruticibartGruiticibart
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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | Joseph Shatzel, M.D. (PRINCIPAL_INVESTIGATOR) |
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