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

Official title

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

Overview

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.

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. .

Interventions

• Drug Placebo
  Given IV or via catheter
• Drug Gruticibart
  2mg/kg, 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

Primary outcome measures

• Number of participants with catheter-related thrombosis [Time frame: 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)]

Secondary outcome measures (3)

• The number of subjects with treatment-related adverse events (TEAEs) [Time frame: 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)]
• The number of participants with any thrombosis [Time frame: Day 1 to end of treatment (up to 14 days)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• OHSU Knight Cancer Institute — Portland

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. PMID 15842354

Identifiers

NCT: NCT07498517 · STUDY00028611 · R44HL170881 · 3G3-22-06

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗