90 Participants NeededMy employer runs this trial

Gruticibart for Blood Clots

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: OHSU Knight Cancer Institute
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, gruticibart, to determine its effectiveness in preventing blood clots around central venous catheters (CVCs). These clots can cause pain and swelling and often require blood thinners, which have their own risks. Participants will receive either gruticibart or a placebo to compare effects. The trial seeks individuals planning to have a CVC inserted as part of their treatment and who can pause their therapy briefly. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but you cannot be on anticoagulation (blood thinners) at the time of enrollment.

Is there any evidence suggesting that gruticibart is likely to be safe for humans?

Research has shown that gruticibart, a monoclonal antibody, has been safe in past studies. These studies found no major side effects or bleeding problems. This is important because the drug aims to prevent blood clots without the bleeding risk often associated with blood thinners. Gruticibart blocks Factor XI, a protein that aids in blood clotting. The research suggests that targeting this protein can help prevent clots without causing bleeding issues. So far, the safety data for gruticibart appears promising.12345

Why do researchers think this study treatment might be promising?

Unlike standard treatments for blood clots, which typically include anticoagulants like warfarin or direct oral anticoagulants (DOACs), Gruticibart stands out due to its unique mechanism of action. While most anticoagulants work by thinning the blood or inhibiting clotting factors, Gruticibart directly targets and dissolves existing clots. This innovative approach could potentially offer a faster and more direct way to manage blood clots, reducing the risk of complications associated with prolonged clot presence. Researchers are particularly excited about Gruticibart's potential to work quickly and effectively, offering a promising new avenue for treating this condition.

What evidence suggests that gruticibart might be an effective treatment for catheter-related thrombosis?

Research has shown that gruticibart, a monoclonal antibody, might help prevent blood clots linked to catheters. In earlier studies, gruticibart significantly delayed clotting time, indicating its potential for clot prevention. Patients tolerated it well, with no major bleeding issues. Another study found that gruticibart successfully prevented clots in mechanical heart valves, further supporting its potential against catheter-related clots. In this trial, participants will receive either gruticibart or a placebo to evaluate its effectiveness in reducing blood clots in patients with central venous catheters.23467

Who Is on the Research Team?

JS

Joseph Shatzel, M.D.

Principal Investigator

OHSU Knight Cancer Institute

Are You a Good Fit for This Trial?

This trial is for adults (18+) who are getting a central venous catheter as part of their treatment, have good physical health (ECOG ≤2), enough platelets, and can give consent. Women able to become pregnant must test negative for pregnancy and use two forms of birth control during the study.

Inclusion Criteria

I am able to care for myself and do daily activities.
* Platelet count \> 50 x 109/L
* Ability to understand and the willingness to sign a written informed consent document.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of gruticibart or placebo via IV

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
Follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

  • Gruticibart

Trial Overview

The study tests if a single dose of gruticibart, compared to placebo, can prevent blood clots at the site where a central line is placed. Participants are randomly assigned to receive either gruticibart or placebo. Ultrasound and lab samples help monitor results.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm B: GruticibartExperimental Treatment3 Interventions
Group II: Arm A: PlaceboPlacebo Group3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

OHSU Knight Cancer Institute

Lead Sponsor

Trials
239
Recruited
2,089,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Oregon Health and Science University

Collaborator

Trials
1,024
Recruited
7,420,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37970718/

Factor XI Inhibition for the Prevention of Catheter-Associated ...

Conclusions: FXI inhibition with gruticibart was well tolerated without any significant adverse or bleeding-related events and resulted in a ...

Factor XI Inhibition for the Prevention of Catheter ...

The anti-FXI mAb, gruticibart, significantly prolonged the activated partial thromboplastin time in all subjects on day 14 compared with baseline (P<0.001).

Gruticibart for Blood Clots · Info for Participants

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 ...

Targeting factor XI and factor XIa to prevent thrombosis

85 Over 26 weeks, the primary efficacy outcome occurred at similar rates in the asundexian (19%-22%) and placebo (19%) arms. International. Society on ...

Targeting factor XI as a compromise between thrombosis ...

The anticoagulant effect of abelacimab was observed in mice in 2005 [40]. In animal models, abelacimab demonstrated superior efficacy compared ...

Safety and Efficacy of a Single Dose of Gruticibart to ...

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 ...

gruticibart (AB023) / Aronora, Xoma

Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT ... - "Presentation to include clinical data from a phase 2 study of Gruticibart (AB023) ...