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

NCT07498517 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: STUDY00028611R44HL1708813G3-22-06
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thrombosis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• The number of subjects with treatment-related adverse events (TEAEs)

  Day 1 to end of folllow up (up to 30 days)

• Time to detection of CRT

  Day 1 to end of treatment (up to 14 days)

• The number of participants with any thrombosis

  Day 1 to end of treatment (up to 14 days)

Study Arms (2)

Arm A: Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo; Procedure: Ultrasound; Procedure: Biopspecimen collection

Arm B: Gruticibart

EXPERIMENTAL

Gruiticibart

Drug: Gruticibart; Procedure: Ultrasound; Procedure: Biopspecimen collection

Interventions

Placebo DRUG

Given IV or via catheter

Arm A: Placebo

Gruticibart DRUG

2mg/kg, Given IV or via catheter

Arm B: Gruticibart

Ultrasound PROCEDURE

Undergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )

Arm A: Placebo; Arm B: Gruticibart

Biopspecimen collection PROCEDURE

Undergo blood sample collection

Arm A: Placebo; Arm B: Gruticibart

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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.

  PMID: 15842354 BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Joseph Shatzel, M.D.

  OHSU Knight Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: February 28, 2026
• Primary Completion (Estimated): February 2, 2029
• Study Completion (Estimated): October 2, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)