A Study to Evaluate the Safety and Efficacy of a Single Dose of Gruticibart for the Prevention of Early Catheter-related Thrombosis
OHSU Knight Cancer Institute
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.
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: Participan…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document. * Men and women, aged ≥ 18 years. * In consultation with PI and treating physician, participant's therapy allows for a 1 to 2-day period between administration of study drug and subsequent start of planned therapy. * Individuals that will undergo insertion of a CVC as part of planned therapy per institutional standards. * Must have ECOG performance status ≤ 2 (refer to Appendix A). * At time of enrollment, must have: * Platelet count \> 50 x 109/L * Female participants of childbeari…
Interventions
- DrugPlacebo
Given IV or via catheter
- DrugGruticibart
2mg/kg, Given IV or via catheter
- ProcedureUltrasound
Undergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )
- ProcedureBiopspecimen collection
Undergo blood sample collection
Location
- OHSU Knight Cancer InstitutePortland, Oregon