Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT (NCT07498517) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT
United States90 participantsStarted 2026-02-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 st…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with catheter-related thrombosis
Timeframe: Day 1 to end of follow up (up to 14 days)
2
Incidence of major and clinically-relevant bleeding
Timeframe: Day 1 up to end of treatment (up to 14 days)