Gruticibart to Prevent Catheter-Related Blood Clots

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized phase II study, adults with a central venous catheter receive either a single dose of gruticibart or placebo to see if it lowers the risk of catheter-related thrombosis. The study also monitors safety and tolerability, including any bleeding or other adverse events, over 30 days after dosing. Participants are followed to assess time to thrombosis and any additional thrombotic events. The trial is conducted at the OHSU Knight Cancer Institute with collaboration from NHLBI and Oregon Health & Science University.

Why it matters

Who can join: the full rules

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 it's running

• OHSU Knight Cancer Institute
  Portland, Oregon, United States Recruiting

Study contacts

• Principal investigator: Joseph Shatzel, M.D. — OHSU Knight Cancer Institute

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.