此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease (SOF/VEL ESRD)

2020年2月18日 更新者：Gilead Sciences

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic HCV Infection Who Are on Dialysis for End Stage Renal Disease

The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

59

阶段

  • 阶段2

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

  • 以色列
      • Jerusalem、以色列、9103102
        • Shaare Zedek Medical Center
      • Ramat Gan、以色列、52173
        • The Chaim Sheba Medical Centre
      • Tel Aviv、以色列、64239
        • Tel Aviv Sourasky Medical Center
  • 加拿大
    • Alberta
      • Edmonton、Alberta、加拿大
        • Kaye Edmonton Clinic
    • British Columbia
      • Vancouver、British Columbia、加拿大、BC V5Z 1M9
        • Gordon and Leslie Diamond Health Care Center, Vancouver General Hospital, UBC Division of Gastroenterology
    • Ontario
      • Brampton、Ontario、加拿大
        • William Osler Health System- Brampton Civic Hospital
      • Hamilton、Ontario、加拿大、ON L8V
        • Hamilton Health Sciences - McMaster University Medical Centre Site
      • Ottawa、Ontario、加拿大、K1H 8L6
        • Ottawa Hospital Research Institute
    • Quebec
      • Montréal、Quebec、加拿大、H2X 3J4
        • Centre de recherche du centre hospitalier de l'Université de Montréal (CRCHUM)
  • 新西兰
    • Auckland
      • Grafton、Auckland、新西兰、1010
        • Auckland City Hospital
  • 澳大利亚
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Royal Adelaide Hospital
  • 英国
      • Glasgow、英国、G12 0YN
        • Gartnavel General Hospital
      • London、英国、SE5 9RS
        • King's College Hospital
      • London、英国、SW10 9NH
        • Chelsea and Westminster Hospital
      • London、英国、E1 1BB
        • Barts Health NHS Trust
      • London、英国、W2 1NY
        • Imperial College Healthcare NHS Trust
      • Nottingham、英国、NG5 1PB
        • Nottingham University Hospitals NHS Trust
      • Plymouth、英国、PL6 8DH
        • Derriford Hospital
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron
      • Majadahonda、西班牙、28222
        • Hospital Universitario Puerta de Hierro - Majadahonda
      • Sevilla、西班牙、41013
        • Hospital Universitario Virgen del Rocío
    • Madrid
      • Alcorcón、Madrid、西班牙、28922
        • Hospital Universitario Fundacion Alcorcon

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 及以上 (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

Key Inclusion Criteria:

  • Chronic HCV infected, male and non-pregnant/non-lactating females aged 18 years or older who are on dialysis for ESRD, including adults with HIV co-infection if they are suppressed on a stable, protocol-approved antiretroviral (ARV) regimen for ≥8 weeks prior to screening.

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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：不适用
  • 介入模型：单组作业
  • 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：声光/声光
SOF/VEL 12 周
药品：SOF/VEL
400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
其他名称：
  • Epclusa®
  • GS-7977/GS-5816

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
Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)
大体时间：Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) 12 weeks after stopping the study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued the Study Drug Due to an Adverse Event
大体时间：First dose date up to Week 12
First dose date up to Week 12

次要结果测量

结果测量
措施说明
大体时间
停止治疗后 4 周具有持续病毒学应答的参与者百分比 (SVR4)
大体时间：治疗后第 4 周
SVR4 定义为停止研究治疗后 4 周 HCV RNA < LLOQ。
治疗后第 4 周
Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)
大体时间：Posttreatment Week 24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after stopping study treatment.
Posttreatment Week 24
Change From Baseline in HCV RNA
大体时间：Baseline; Weeks 2, 4, 6, 8, and 12
Baseline; Weeks 2, 4, 6, 8, and 12
Percentage of Participants With HCV RNA < LLOQ on Treatment
大体时间：Weeks 2, 4, 6, 8, and 12
Weeks 2, 4, 6, 8, and 12
病毒学失败的参与者百分比
大体时间：治疗后第 24 周的基线

病毒学失败定义为：

  • 治疗中病毒学失败：

    • 突破（HCV RNA ≥ LLOQ，之前在接受治疗时 HCV RNA < LLOQ），或
    • 反弹（确认治疗期间 HCV RNA 从最低点增加 > 1 log10 IU/mL），或
    • 无反应（HCV RNA 在 8 周治疗期间持续≥ LLOQ）

  • 病毒学复发：

    • 在治疗后期间确认的 HCV RNA ≥ LLOQ 在最后一次治疗访视时达到 HCV RNA < LLOQ
治疗后第 24 周的基线
Number of Participants Who Develop Viral Resistance (as Assessed by Presence of HCV NS5A and NS5B Genes) to SOF and VEL During Treatment and After Discontinuation of Treatment
大体时间：First dose date up to Posttreatment Week 24
Baseline deep sequencing of the HCV NS5A and NS5B genes was performed for all participants. For all participants with virologic failure, deep sequencing was performed at the first time point after virologic failure if the plasma or serum sample was available and HCV RNA was > 1000 IU/mL.
First dose date up to Posttreatment Week 24
Pharmacokinetic (PK) Parameter: AUCtau of SOF
大体时间：Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: AUCtau of GS-331007 (Metabolite of SOF)
大体时间：Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
AUCtau is defined as the population PK derived area under the concentration versus time curve of the drug over the dosing interval.
Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: AUCtau of VEL
大体时间：Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
AUCtau is defined as the population PK derived area under the concentration verses time curve of the drug over the dosing interval.
Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of SOF
大体时间：Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Cmax is defined as the population PK derived maximum concentration of the drug.
Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of GS-331007 (Metabolite of SOF)
大体时间：Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Cmax is defined as the population PK derived maximum concentration of the drug.
Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Cmax of VEL
大体时间：Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Cmax is defined as the population PK derived maximum concentration of the drug.
Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
PK Parameter: Ctau of VEL
大体时间：Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))
Ctau is defined as the population PK derived concentration of the drug at the end of a 24 hour dosing interval. The 24 hour Ctau is estimated based on the combination of sparse PK samples collected at random times across the dosing interval as well as intensive PK samples collected for up to 12 hours post-dose.
Sparse PK samples at Weeks 6, 8, and 12 (all participants). Intensive PK samples at predose, 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours postdose once at Week 6, 8, or 12 (participants who enrolled in the optional PK substudy (N=1))

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

Gilead Sciences

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)

2017年3月22日

初级完成 (实际的)

2018年8月13日

研究完成 (实际的)

2018年11月7日

研究注册日期

首次提交

2017年1月27日

首先提交符合 QC 标准的

2017年1月27日

首次发布 (估计)

2017年1月30日

研究记录更新

最后更新发布 (实际的)

2020年3月6日

上次提交的符合 QC 标准的更新

2020年2月18日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • GS-US-342-4062
  • 2016-003625-42 (EudraCT编号)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

IPD 共享时间框架

18 months after study completion

IPD 共享访问标准

A secured external environment with username, password, and RSA code.

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)

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

是的

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.

订阅