Safety and Efficacy of a Single Dose of Gruticibart to Prevent CRT

August 27, 2026 updated by: Joseph Shatzel M.D., OHSU Knight Cancer Institute

A Study to Evaluate the Safety and Efficacy of a Single Dose of Gruticibart for the Prevention of Early Catheter-related Thrombosis

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE(S):

I. To determine the safety of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC II. To determine the efficacy of gruticibart as measured by the incidence of CRT in individuals with a CVC

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of gruticibart in patients with a CVC II. To determine the efficacy of gruticibart as measured by the time to CRT and incidence of any thrombosis in individuals with a CVC

OUTLINE: Participants are randomized to 1 of 2 arms.

Arm A. Participants receive single dose of placebo IV via CVC or peripheral IV line.

Arm B. Participantsreceive single dose of gruticibart (2 mg/kg) IV via CVC or peripheral IV line.

After completion of study treatment, participants will be followed for AEs for a total of 30 days from time of administration of study drug, and are considered off-study after 30 days. .

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • OHSU Knight Cancer Institute
        • Principal Investigator:
          • Joseph Shatzel, M.D.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Arm A: Placebo
Placebo
Drug: Placebo
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
Experimental: Arm B: Gruticibart
Gruiticibart
Procedure: Ultrasound
Undergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )
Procedure: Biopspecimen collection
Undergo blood sample collection
Drug: Gruticibart
2mg/kg, Given IV or via catheter

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 to end of follow up (up to 14 days)
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
Day 1 up to end of treatment (up to 14 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of subjects with treatment-related adverse events (TEAEs)
Time Frame: Day 1 to end of folllow up (up to 30 days)
TEAEs will be summarized using frequency counts (safety and tolerability)
Day 1 to end of folllow up (up to 30 days)
Time to detection of CRT
Time Frame: Day 1 to end of treatment (up to 14 days)
Mean number of minutes until CRT is detected
Day 1 to end of treatment (up to 14 days)
The number of participants with any thrombosis
Time Frame: Day 1 to end of treatment (up to 14 days)
Any thrombosis, including deep vein thrombosis, CRT, myocardial infarction, stroke, pulmonary embolism. Administration of gruticibart immediately preceding CVC line placement
Day 1 to end of treatment (up to 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
OHSU Knight Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joseph Shatzel, M.D., OHSU Knight Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 2, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY00028611
  • R44HL170881 (U.S. NIH Grant/Contract)
  • 3G3-22-06 (Other Identifier: OHSU Knight Cancer Institute)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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