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

ConditionThrombosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOHSU Knight Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Drug

    Given IV or via catheter

  • Gruticibart

    Drug

    2mg/kg, Given IV or via catheter

  • Ultrasound

    Procedure/Surgery

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

  • Biopspecimen collection

    Procedure/Surgery

    Undergo blood sample collection

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Arm A: PlaceboPlacebo comparator 3 interventions
Group B: Arm B: GruticibartExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of participants with catheter-related thrombosis

Defined by the total incidence of symptomatic and asymptomatic thrombosis.

Time frame
Day 1 to end of follow up (up to 14 days)
2

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

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

Secondary outcomes

1

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

TEAEs will be summarized using frequency counts (safety and tolerability)

Time frame
Day 1 to end of folllow up (up to 30 days)
2

Time to detection of CRT

Mean number of minutes until CRT is detected

Time frame
Day 1 to end of treatment (up to 14 days)
3

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OHSU Knight Cancer Institute

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Oregon Health and Science University

Collaborator

Source ClinicalTrials.gov
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