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A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

2014年7月9日 更新者：Vertex Pharmaceuticals Incorporated

A Phase 2 Study of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Achieved Sustained Viral Response With a Prior Course of Interferon Based Therapy

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

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)

465

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4N1
        • University of Calgary Medical Clinic - Health Science Centre
      • Edmonton、Alberta、加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • BC Hepatitis Program
    • Manitoba
      • Winnipeg、Manitoba、加拿大
    • Ontario
      • Toronto、Ontario、加拿大
      • Toronto、Ontario、加拿大
        • Toronto Western Hospital
  • 德国
      • Berlin、德国
        • Universitätsmedizin Berlin
      • Frankfurt、德国
        • University Clinic Frankfurt, Department of Internal Medicine
  • 波多黎各
      • Santurce、波多黎各
  • 美国
    • Alabama
      • Birmingham、Alabama、美国
        • Birmingham Gastroenterology Associates
    • California
      • Los Angeles、California、美国、90048
        • Cedars-Sinai Medical Center
      • Los Angeles、California、美国
        • USC
      • San Diego、California、美国
        • University of California, San Diego
      • San Diego、California、美国
        • Kaiser Permanente Hepatology Research
      • San Francisco、California、美国
        • University of California San Francisco
    • Colorado
      • Denver、Colorado、美国
        • University of Colorado Health Sciences Center
      • Englewood、Colorado、美国
    • Florida
      • Bardenton、Florida、美国
      • Gainesville、Florida、美国
        • University of Florida
      • Jacksonville、Florida、美国
        • Borland-Groover Clinic
      • Jacksonville、Florida、美国
        • Mayo Clinic Jacksonville
      • Miami、Florida、美国
      • Sarasota、Florida、美国
        • University Hepatitis Center at Bach & Godofsky
    • Georgia
      • Atlanta、Georgia、美国
    • Illinois
      • Chicago、Illinois、美国
    • Indiana
      • Indianapolis、Indiana、美国
    • Louisiana
      • Baton Rouge、Louisiana、美国
        • Gulf Coast Research, LLC
    • Maine
      • Portland、Maine、美国
        • Virology Treatment Center, Maine Medical Center
    • Maryland
      • Baltimore、Maryland、美国
        • Johns Hopkins University
    • Massachusetts
      • Boston、Massachusetts、美国
        • Beth Isreal Deaconess Medical Center
    • Michigan
      • Detroit、Michigan、美国
        • Henry Ford Hospital
    • Missouri
      • St Louis、Missouri、美国
        • Saint Louis University
    • Nebraska
      • Omaha、Nebraska、美国
    • New Mexico
      • Albuquerque、New Mexico、美国
    • New York
      • Manhasset、New York、美国
        • North Shore University Hospital
      • New York、New York、美国
    • North Carolina
      • Durham、North Carolina、美国
    • Ohio
      • Cincinnati、Ohio、美国
        • University Internal Medicine Associates, Inc.
      • Cleveland、Ohio、美国
        • Cleveland Clinic
    • Pennsylvania
      • Hershey、Pennsylvania、美国
      • Pittsburgh、Pennsylvania、美国
    • South Carolina
      • Columbia、South Carolina、美国
        • Columbia Gastroenterology Associates, PA
    • Tennessee
      • Germantown、Tennessee、美国
        • Memphis Gastroenterology Group
    • Texas
      • Dallas、Texas、美国
        • Liver Institute at Methodist Dallas
      • Houston、Texas、美国
        • Advanced Liver Therapies
      • San Antonio、Texas、美国
        • Alamo Medical Research
    • Virginia
      • Annandale、Virginia、美国
      • Fairfax、Virginia、美国
        • Metropolitan Research
      • Richmond、Virginia、美国
    • Washington
      • Seattle、Washington、美国
  • 荷兰
      • Amsterdam、荷兰
        • Academic Medical Center
      • Leiden、荷兰
        • Leiden University Medical Center
      • Rotterdam、荷兰
        • Erasmus MC University Medical Center

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 70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:

  • Males and females between 18 and 70 years old
  • Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
  • Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
  • Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
  • Must be judged to be in general good health and able to receive Pegasys® and Copegus®
  • No drug or alcohol abuse in the last year
  • Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
  • If you are a woman, you cannot be in this study if you are pregnant or nursing

Exclusion Criteria:

  • Participation in any clinical trial of a HCV protease inhibitor of any duration
  • Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
  • Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
  • Diagnosed or suspected hepatocellular carcinoma
  • History of or current evidence of decompensated liver disease
  • Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)

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：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
药品：利巴韦林
药片
其他名称：
  • RBV
药品：聚乙二醇干扰素α2a
注射液
其他名称：
  • Peg-IFN-alfa-2a
药品：特拉匹韦
药片
其他名称：
  • VX-950
实验性的：Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
药品：利巴韦林
药片
其他名称：
  • RBV
药品：聚乙二醇干扰素α2a
注射液
其他名称：
  • Peg-IFN-alfa-2a
药品：特拉匹韦
药片
其他名称：
  • VX-950
实验性的：Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week
Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
药品：聚乙二醇干扰素α2a
注射液
其他名称：
  • Peg-IFN-alfa-2a
药品：特拉匹韦
药片
其他名称：
  • VX-950
安慰剂比较：PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
药品：利巴韦林
药片
其他名称：
  • RBV
药品：聚乙二醇干扰素α2a
注射液
其他名称：
  • Peg-IFN-alfa-2a
药品：Matching Placebo
Tablet

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
研究药物给药完成后第 24 周时血浆丙型肝炎病毒 (HCV) 核糖核酸 (RNA) 检测不到的受试者百分比
大体时间：完成研究药物给药后 24 周（直至第 72 周）
使用 Roche TaqMan HCV RNA 测定法测量血浆 HCV RNA 水平。 检测下限为每毫升 10 个国际单位 (IU/mL)。
完成研究药物给药后 24 周（直至第 72 周）

次要结果测量

结果测量
措施说明
大体时间
Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
大体时间：Completion of study drug dosing (up to Week 48)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Completion of study drug dosing (up to Week 48)
Percentage of Subjects With Undetectable Plasma HCV RNA
大体时间：Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
Percentage of subjects with undetectable HCV RNA at 24 weeks after last dose of study drug for treatment group "PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week" and at 48 weeks after last dose of study drug for treatment groups "Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week", "Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week" and "Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week" were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Up to Week 96 (24 weeks after last dose of study drug for PBO group; 48 weeks after last dose of study drug for telaprevir groups)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline up to 2 weeks after last dose of study drug (up to Week 50)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Baseline up to 2 weeks after last dose of study drug (up to Week 50)
Number of Subjects With Viral Relapse
大体时间：After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
After last dose of study drug up to 24 week antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
大体时间：Week 2, 4, 8, 12, 16, 24
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Week 2, 4, 8, 12, 16, 24

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

Vertex Pharmaceuticals Incorporated

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

2007年2月1日

初级完成 (实际的)

2008年12月1日

研究完成 (实际的)

2009年4月1日

研究注册日期

首次提交

2007年1月8日

首先提交符合 QC 标准的

2007年1月8日

首次发布 (估计)

2007年1月11日

研究记录更新

最后更新发布 (估计)

2014年8月5日

上次提交的符合 QC 标准的更新

2014年7月9日

最后验证

2014年7月1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

  • VX06-950-106

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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