Thrombosis
Conditions
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.
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
DRUGPlacebo
Given IV or via catheter
DRUGGruticibart
2mg/kg, Given IV or via catheter
PROCEDUREUltrasound
Undergo ultrasound of CVC and both legs for Deep Vein Thrombosis (DVTs )
PROCEDUREBiopspecimen collection
Undergo blood sample collection
Sponsors
OHSU Knight Cancer Institute
National Heart, Lung, and Blood Institute (NHLBI)
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with catheter-related thrombosis | Day 1 to end of follow up (up to 14 days) | Defined by the total incidence of symptomatic and asymptomatic thrombosis. |
| Incidence of major and clinically-relevant bleeding | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The number of participants with any thrombosis | 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 |
| The number of subjects with treatment-related adverse events (TEAEs) | Day 1 to end of folllow up (up to 30 days) | TEAEs will be summarized using frequency counts (safety and tolerability) |
| Time to detection of CRT | Day 1 to end of treatment (up to 14 days) | Mean number of minutes until CRT is detected |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJoseph Shatzel, M.D.
OHSU Knight Cancer Institute
Outcome results
None listed