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CMV Antiviral Prevention Strategies in D+R-Liver Transplants ("CAPSIL")

2021年7月29日 更新者：National Institute of Allergy and Infectious Diseases (NIAID)

Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in High-Risk R-D+ Liver Transplant Recipients

This is a trial of preemptive therapy vs. prophylaxis for prevention of Cytomegalovirus (CMV) disease in R-D+ liver transplant patients. Subjects will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir, 900 mg orally once daily or preemptive therapy (weekly monitoring for CMV viremia by plasma PCR) for 100 days post-randomization with initiation of oral valganciclovir 900mg orally twice daily at onset of CMV viremia and continued until plasma PCR is negative on two consecutive weekly PCR tests). A minimum of 176 subjects will be enrolled in the study. The study duration is 7 years. The primary objective of this study is to compare prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease in R-/D+ liver transplant recipients.

研究概览

地位

完全的

条件

干预/治疗

详细说明

This is a prospective, randomized, multicenter trial of preemptive therapy vs. prophylaxis for prevention of Cytomegalovirus (CMV) disease in seronegative recipient- seropositive donor (R-D+) liver transplant patients.Subjects will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once daily or preemptive therapy for 100 days post-randomization with initiation of oral valganciclovir 900mg orally twice daily at onset of CMV viremia (monitored weekly) and continued until plasma PCR is negative on two consecutive weekly PCR tests. Study participants will be followed during the intervention period (100 days post randomization) and until 12 months post-transplant for CMV disease, toxicity, and clinical outcomes (opportunistic infections, rejection, graft loss and mortality). Drug safety labs will be assessed and recorded for the entire treatment period in both the prophylaxis and preemptive group. Re-transplantation and all-cause mortality will also be assessed at study closure and no longer than 5 years after enrollment. Additionally, the impact of the two CMV prevention strategies on CMV-specific cellular and humoral immune responses will be evaluated at 100 days after randomization, and 6 and 12 months post-transplant. A minimum of 176 subjects will be enrolled in the study. Allowing for over-enrollment to replace dropouts, up to 205 subjects may be enrolled to achieve the target enrollment of 176. Subjects will be randomized into one of the two groups in 1:1 ratio. The study duration is 7 years. The primary objective of this study is to compare prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease in R-/D+ liver transplant recipients. The secondary objectives are:1) to assess the two preventive strategies for clinical outcomes (major bacterial, fungal and non-CMV viral infections, rejection, graft loss and mortality) at one year post transplantation; 2) to assess the two preventive strategies for hematologic toxicity (assessment of neutropenia and receipt of hematopoietic growth factor during study days 1-107).

研究类型

介入性

注册 (实际的)

205

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Los Angeles、California、美国、90095-8358
        • Ronald Reagan University of California Los Angeles Medical Center
    • Georgia
      • Atlanta、Georgia、美国、30322-1013
        • Emory Clinic - Transplant Center
    • Minnesota
      • Rochester、Minnesota、美国、55905-0001
        • Mayo Clinic, Rochester - Infectious Diseases
    • New York
      • New York、New York、美国、10029-6504
        • Mount Sinai School of Medicine - Medicine - Infectious Diseases
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213-3403
        • University of Pittsburgh - Medicine - Infectious Diseases
    • Washington
      • Seattle、Washington、美国、98195-7110
        • University of Washington - Medicine

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 99年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Be > / = 18 years of age.
  2. Have negative Cytomegalovirus (CMV) serology (confirmed within 6 months of transplant) and receive a liver from a donor with positive CMV serology (R-/D+).
  3. Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.
  4. Have absolute neutrophil count > 1000/µL at randomization.

  5. - If female, and not postmenopausal or surgically sterile, must have negative pregnancy test (serum or urine) within 48 hours prior to randomization and must also agree to use medically approved method of contraception. Acceptable methods include: barrier method, intrauterine device (hormonal or non-hormonal), oral hormonal contraceptives, abstinence for 100 days after randomization and 3 months after valganciclovir cessation.

    -- If male, and has not had a vasectomy, he must agree to practice barrier method of contraception for 100 days after randomization and 3 months after valganciclovir cessation.

  6. Subject or legally authorized representative has provided written informed consent.

Exclusion Criteria:

  1. Currently enrolled in any interventional trial of an investigational therapeutic agent unless co-enrollment has been approved by study Principal Investigators (PIs) and the DMID prior to enrollment.
  2. Have hypersensitivity to acyclovir, ganciclovir or valganciclovir.
  3. Be breast-feeding mother.
  4. Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).
  5. Be undergoing multi organ transplant or have undergone prior organ transplant.
  6. Have expected life expectancy of less than 72 hours.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Preemptive Therapy
900 mg of Valganciclovir given orally twice daily to Preemptive Therapy subjects upon detection of CMV viremia until plasma PCR is negative on two consecutive weekly PCR test. All dosages adjusted for renal dysfunction. n=88
药品：Valganciclovir
Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 100 days post transplantation as prophylaxis. Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.
有源比较器：Prophylaxis
900 mg of Valganciclovir given orally once daily to subjects for 100 days post transplantation. All dosages adjusted for renal dysfunction. n=88
药品：Valganciclovir
Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 100 days post transplantation as prophylaxis. Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Incidence of Cytomegalovirus (CMV) Disease.
大体时间：365 days post-transplant
CMV disease as verified by an independent end point committee
365 days post-transplant

次要结果测量

结果测量
措施说明
大体时间
All-cause Mortality
大体时间：Up to 365 days post-transplant
Survival probability at 1 year
Up to 365 days post-transplant
Incidence of Allograft Rejection
大体时间：Up to 365 days post-transplant
Number of subjects with allograft rejection
Up to 365 days post-transplant
Graft Loss
大体时间：Up to 365 days post-transplant
Incidence of graft loss (re-transplantation)
Up to 365 days post-transplant
Late-onset CMV Disease
大体时间：Up to 365 days post-transplant
Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee
Up to 365 days post-transplant
Bacterial Infections
大体时间：Up to 365 days post-transplant
Incidence of bacterial opportunistic infections
Up to 365 days post-transplant
Major Fungal Infections
大体时间：Up to 365 days post-transplant
Opportunistic fungal infections
Up to 365 days post-transplant
Major Non-CMV Viral Infections
大体时间：Up to 365 days post-transplant
Incidence of non-CMV viral infections
Up to 365 days post-transplant
Neutropenia
大体时间：Day 1 through Day 107
Incidence of neutropenia less than 1000/µL while on valganciclovir treatment
Day 1 through Day 107
Neutropenia Less Than 500
大体时间：prior to day 107
ANC less than 500 while on valganciclovir
prior to day 107
Hematopoietic Growth Factors
大体时间：Day 1 through Day 107
Hematopoietic growth factor receipt for ANC less than 500 during valganciclovir treatment.
Day 1 through Day 107

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Institute of Allergy and Infectious Diseases (NIAID)

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2012年10月29日

初级完成 (实际的)

2018年6月22日

研究完成 (实际的)

2018年6月22日

研究注册日期

首次提交

2012年3月2日

首先提交符合 QC 标准的

2012年3月8日

首次发布 (估计)

2012年3月13日

研究记录更新

最后更新发布 (实际的)

2021年8月26日

上次提交的符合 QC 标准的更新

2021年7月29日

最后验证

2018年3月22日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 11-0073

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in United Kingdom

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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