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

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: Not yet recruiting
• Conditions: Thrombosis
• Intervention / Treatment: Drug: Placebo; Procedure: Ultrasound; Procedure: Biopspecimen collection; Drug: Gruticibart

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: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Knight Cancer Institute
      • Principal Investigator: Joseph Shatzel, M.D.
      • Contact: Joseph Shatzel, M.D.; Phone Number: 503-494-6594; Email: shatzel@ohsu.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Number of participants with catheter-related thrombosis	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	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

Outcome Measure	Measure Description	Time Frame
The number of subjects with treatment-related adverse events (TEAEs)	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	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	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

• Sponsor: OHSU Knight Cancer Institute
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Oregon Health and Science University
• Investigators: Principal Investigator: Joseph Shatzel, M.D., OHSU Knight Cancer Institute

Publications and helpful links

General Publications

• Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2026
• Primary Completion (Estimated): February 2, 2029
• Study Completion (Estimated): October 2, 2029

Study Registration Dates

• First Submitted: March 23, 2026
• First Submitted That Met QC Criteria: March 23, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID 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