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A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

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

A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

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)

117

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
        • University of Calgary Medical Clinic
      • Edmonton、Alberta、加拿大
        • University of Alberta
    • British Columbia
      • Vancouver、British Columbia、加拿大
        • University of British Columbia Vancouver General Hospital
    • Manitoba
      • Winnipeg、Manitoba、加拿大
    • Ontario
      • Toronto、Ontario、加拿大
  • 奥地利
      • Vienna、奥地利
  • 德国
      • Berlin、德国
      • Bonn、德国
        • Universitätsklinikum Bonn
      • Cologne、德国
        • University of Cologne
      • Dusseldorf、德国、40225
        • Uniklinik Duesseldorf
      • Frankfurt、德国
      • Hannover、德国
  • 法国
      • Creteil、法国
        • Hospital Henri Mondor
      • Lyon、法国
      • Nice、法国
      • Paris、法国
      • Pessac、法国
      • Vandoeuvre、法国
  • 波多黎各
      • Santurce、波多黎各
        • Fundacion de Investigation de Diego
  • 美国
    • Alabama
      • Birmingham、Alabama、美国
    • California
      • Los Angeles、California、美国
      • San Diego、California、美国
        • Kaiser Permanente Internal Medicine
      • San Francisco、California、美国
    • Colorado
      • Denver、Colorado、美国
        • University of Colorado Health Sciences Center
      • Englewood、Colorado、美国
        • South Denver Gastroenterology
    • Florida
      • 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
        • University of Miami Center for Liver Diseases
      • Sarasota、Florida、美国
    • Georgia
      • Atlanta、Georgia、美国
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago、Illinois、美国
        • University of Chicago
    • Indiana
      • Indianapolis、Indiana、美国
    • Louisiana
      • Baton Rouge、Louisiana、美国
        • Digestive and Liver Disease Clinic
    • 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 Israel Deaconess Medical Center
      • Worcester、Massachusetts、美国
        • University of Massachusetts Memorial Medical Center
    • Michigan
      • Detroit、Michigan、美国
        • Henry Ford Hospital
    • Missouri
      • St Louis、Missouri、美国
        • St Louis University
    • Nebraska
      • Omaha、Nebraska、美国
        • The Nebraska Medical Center
    • New Mexico
      • Albuquerque、New Mexico、美国
        • University of New Mexico
    • New York
      • Manhasset、New York、美国
        • North Shore University Hospital
      • New York、New York、美国
    • North Carolina
      • Durham、North Carolina、美国
        • Duke University Medical Center
    • Ohio
      • Cincinnati、Ohio、美国
        • University of Cincinnati
      • Cleveland、Ohio、美国
    • Pennsylvania
      • Hershey、Pennsylvania、美国
        • Penn State Hershey Medical Center
      • Pittsburgh、Pennsylvania、美国
        • University of Pittsburgh Medical Center
    • 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
      • San Antonio、Texas、美国
        • Alamo Medical Research
    • Virginia
      • Annandale、Virginia、美国
      • Charlottesville、Virginia、美国
        • University of Virginia Health Systems
      • Fairfax、Virginia、美国
        • Metropolitan Research
      • Richmond、Virginia、美国
        • McGuire DVAMC
  • 英国
      • London、英国
  • 荷兰
      • Amsterdam、荷兰
        • Academic Medical Center
      • Leiden、荷兰
        • Leiden University Medical Center
      • Rotterdam、荷兰
        • Erasmus MC 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:

  • Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

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：非随机化
  • 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：Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week
Telaprevir 750 mg 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
药品：特拉匹韦
药片
其他名称：
  • VX-950
药品：Pegylated interferon alfa 2a
Solution for Injection
实验性的：Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week
Telaprevir 750 mg tablet thrice daily for 12 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
药品：特拉匹韦
药片
其他名称：
  • VX-950
药品：Pegylated interferon alfa 2a
Solution for Injection
实验性的：Other
Subjects received telaprevir 750 mg tablet thrice daily 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 <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group.
药品：利巴韦林
药片
药品：特拉匹韦
药片
其他名称：
  • VX-950
药品：Pegylated interferon alfa 2a
Solution for Injection

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 Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
大体时间：24 weeks after the completion of treatment (up to Week 72)
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).
24 weeks after the completion of treatment (up to Week 72)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline through Week 48
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 through Week 48

次要结果测量

结果测量
措施说明
大体时间
Percentage of Prior Relapsers With Undetectable HCV RNA
大体时间：24 weeks after the completion of treatment (up to Week 72)
Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study 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).
24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response
大体时间：End of treatment (up to Week 48)
Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. 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).
End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
大体时间：48 weeks after completion of treatment (up to Week 96)
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).
48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
大体时间：Baseline up to Week 72
Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
Baseline up to Week 72

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

合作者

Tibotec, Inc

调查人员

  • 研究主任：Nathalie Adda, MD、Vertex Pharmaceuticals Incorporated

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10月1日

初级完成 (实际的)

2010年2月1日

研究完成 (实际的)

2010年2月1日

研究注册日期

首次提交

2007年9月25日

首先提交符合 QC 标准的

2007年9月25日

首次发布 (估计)

2007年9月26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

  • VX06-950-107

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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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

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