A Study to Evaluate the Safety and Efficacy of a Single Dose of Gruticibart for the Prevention of Early Catheter-related Thrombosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Number of participants with catheter-related thrombosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 -
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm A: Placebo
Placebo
干预措施: Placebo (Drug)
Arm A: Placebo
Placebo
干预措施: Ultrasound (Procedure)
Arm A: Placebo
Placebo
干预措施: Biopspecimen collection (Procedure)
Arm B: Gruticibart
Gruiticibart
干预措施: Ultrasound (Procedure)
Arm B: Gruticibart
Gruiticibart
干预措施: Biopspecimen collection (Procedure)
Arm B: Gruticibart
Gruiticibart
干预措施: Gruticibart (Drug)
结局指标
主要结局
Number of participants with catheter-related thrombosis
时间窗: 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
时间窗: 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
次要结局
- 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))
研究者
Joseph Shatzel M.D.
Principal Investigator
OHSU Knight Cancer Institute