NCT07498517 · OHSU Knight Cancer Institute
Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Placebo
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
Primary outcome measures
Number of participants with catheter-related thrombosis
Time frame: Day 1 to end of follow up (up to 14 days)
Defined by the total incidence of symptomatic and asymptomatic thrombosis.
Incidence of major and clinically-relevant bleeding
Time frame: Day 1 up to end of treatment (up to 14 days)
Safety outcome is defined using the International Society of Thrombosis and Hemostasis definition of major bleeding for clinical investigations of anti-hemostatic medicinal products in nonsurgical patients
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 childbearing potential must have a negative urine or serum pregnancy test during screening and at check-in Day -1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- Participants of childbearing potential are defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal.
- Female participants of childbearing potential must agree to use two forms of highly effective contraception (Appendix B) starting with the first dose of study therapy through 90 days after the last dose of study therapy. Participants of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \>1 year without an alternative medical cause.
- Male participants must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy.
Exclusion criteria
- 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
- At time of enrollment:
- Deranged baseline clotting, where INR \> 1.5
- Known bleeding diathesis
- Use of anticoagulation, either therapeutic or prophylactic, for any indication at enrollment
- -At the discretion of the investigator, any other contraindication to anticoagulation therapy
- Previously documented hypersensitivity to either the drug or excipients.
- Psychiatric illness/social situations, or any other condition, that in the opinion of the investigator, would limit compliance with study requirements.
- Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 90 days after study drug administration.
Where
- Portland, Oregon
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Oregon Health and Science University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2026 · Source of record for eligibility and locations