Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT
ConditionThrombosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
Concurrent enrollment in another therapeutic clinical trial
Active leukemia (lymphoma and myeloma may be included)
Primary brain tumors or known brain metastases
Active infection and/or current use of an oral antibiotic
Trial design
Treatments tested in this trial
- Placebo
- Gruticibart
- Ultrasound
- Biopspecimen collection
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
OHSU Knight Cancer Institute
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Oregon Health and Science University
Collaborator
Source ClinicalTrials.gov