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Sofosbuvir + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection (FUSION) (FUSION)

2014年5月9日 更新者：Gilead Sciences

A Phase 3, Multicenter, Randomized, Double-Blind, Study to Investigate the Efficacy and Safety of GS-7977 + Ribavirin for 12 or 16 Weeks in Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

This study was to assess the safety and efficacy of sofosbuvir in combination with ribavirin (RBV) administered for 12 or 16 weeks in participants with genotypes 2 or 3 hepatitis C virus (HCV) infection as assessed by the proportion of participants with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12).

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)

202

阶段

  • 第三阶段

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

  • 加拿大
    • Alberta
      • Calgary、Alberta、加拿大、T2N 4Z6
        • University Of Calgary
      • Edmonton、Alberta、加拿大、T6G 2X8
        • University of Alberta Hospital
      • Edmonton、Alberta、加拿大、T6G 2B7
        • University of Alberta Hospital
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre
      • Vancouver、British Columbia、加拿大、V6Z 2C9
        • University of British Columbia
      • Vancouver、British Columbia、加拿大、V6Z 2K5
        • (G.I.R.I.) Gastrointestinal Research Institute
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3E 3P4
        • University of Manitoba Health Sciences Center
    • Ontario
      • Ottawa、Ontario、加拿大、K1H 8L6
        • The Ottawa Hospital
      • Toronto、Ontario、加拿大、M5T 2S8
        • Toronto Western Hospital
      • Toronto、Ontario、加拿大、M6H 3M1
        • Toronto Liver Centre
      • Toronto、Ontario、加拿大、M5G 1X5
        • Mount Sinai Hospital
    • Quebec
      • Montreal、Quebec、加拿大、H2X 3J4
        • Hopital St. Luc
  • 新西兰
      • Auckland、新西兰、1640
        • Auckland Clinical Studies Limited
      • Christchurch、新西兰、8011
        • Christchurch Hospital
  • 波多黎各
      • San Juan、波多黎各、00927
        • Fundacion De Investigacion de Diego
      • San Juan、波多黎各、00909-1711
        • Clinical Research Puerto Rico Inc
  • 美国
    • California
      • Coronado、California、美国、92118
        • Scti Research Foundation
      • Los Angeles、California、美国、90027
        • Kaiser Permanente
      • Los Angeles、California、美国、90036
        • Peter J. Ruane, MD, Inc.
      • Los Angeles、California、美国、90069
        • Anthony Mills MD, Inc.
      • San Diego、California、美国、92123
        • Medical Associates Research Group, Inc.
      • San Diego、California、美国、92103
        • UCSD Antiviral Research Center
      • San Diego、California、美国、92154
        • Kaiser Permanente
      • San Francisco、California、美国、94115
        • Quest Clinical Research
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado
      • Englewood、Colorado、美国、80113
        • South Denver Gastroenterology, PC
    • District of Columbia
      • Washington、District of Columbia、美国、20009
        • Whitman Walker Clinic
    • Florida
      • Gainesville、Florida、美国、32610-0277
        • University of Florida
      • Jacksonville、Florida、美国、32256
        • Borland-Groover Clinic Baptist
      • Miami、Florida、美国、33136
        • University of Miami
      • New Port Richey、Florida、美国、34653
        • Advanced Research Institute
      • Orlando、Florida、美国、32806
        • Internal Medicine Specialists
      • Orlando、Florida、美国、32803-1851
        • Orlando Immunology Center (ACH)
      • Wellington、Florida、美国、33414
        • South Florida Center of Gastroenterology, P.A.
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Digestive Healthcare of Georgia
      • Marietta、Georgia、美国、30060
        • Gastrointestinal Specialists of Georgia, PC
    • Indiana
      • Indianapolis、Indiana、美国、46237
        • Indianapolis Gastroenterology Research Foundation
    • Kentucky
      • Bowling Green、Kentucky、美国、42101
        • Graves-Gilbert Clinic
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • Gastroenterology Associates, LLC
    • Maryland
      • Lutherville、Maryland、美国、21093
        • Johns Hopkins University
    • Massachusetts
      • Boston、Massachusetts、美国、02114-2696
        • Massachusetts General Hospital
      • Boston、Massachusetts、美国、02115
        • Beth Israel Deaconess Medical Center
      • Springfield、Massachusetts、美国、01105
        • The Research Institute
    • Michigan
      • Novi、Michigan、美国、48377
        • Henry Ford Health System
    • Minnesota
      • Minneapolis、Minnesota、美国、55414
        • Minnesota Gastroenterology, P.A.
    • Missouri
      • Kansas City、Missouri、美国、64131
        • Kansas City Gastroenterology and Hepatology
    • New Jersey
      • Berlin、New Jersey、美国、08009
        • Comprehensive Clinical Research
      • Hillsborough、New Jersey、美国、08844
        • ID care
    • New Mexico
      • Santa Fe、New Mexico、美国、87505
        • Southwest C.A.R.E. Center
    • New York
      • Binghamton、New York、美国、13903
        • Binghamton Gastroenterology Associates
      • New York、New York、美国、10029
        • Mount Sinai School of Medicine
    • North Carolina
      • Asheville、North Carolina、美国、28801
        • Asheville Gastroenterology Associates, P.A.
      • Durham、North Carolina、美国、27710
        • Duke University Medical Center
      • Winston-Salem、North Carolina、美国、27103
        • Digestive Health Specialists, PA
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania
    • Rhode Island
      • Providence、Rhode Island、美国、02906
        • The Miriam Hospital
      • Providence、Rhode Island、美国、02905
        • University Gastroenterology
    • Tennessee
      • Germantown、Tennessee、美国、38138
        • Gastro One
      • Nashville、Tennessee、美国、37211
        • Nashville Gastrointestinal Specialists, Inc
    • Texas
      • Arlington、Texas、美国、76012
        • Texas Clinical Research Institute, LLC
      • Dallas、Texas、美国、75219
        • Southwest Infectious Disease Clinical Research, Inc.
      • San Antonio、Texas、美国、78215
        • Alamo Medical Research
    • Virginia
      • Fairfax、Virginia、美国、22031
        • Metropolitan Research
      • Falls Church、Virginia、美国、22042
        • Inova Fairfax Hospital Center for Liver Diseases
      • Norfolk、Virginia、美国、23502
        • Digestive and Liver Disease Specialists
      • Richmond、Virginia、美国、23226
        • Bon Secours St. Mary's Hospital of Richmond, Inc.
    • Washington
      • Seattle、Washington、美国、98101
        • Virginia Mason 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 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

Inclusion Criteria:

  • Infection with HCV genotype 2 or 3
  • Had cirrhosis determination
  • Prior treatment failure
  • Screening laboratory values within defined thresholds
  • Subject had not been treated with any investigational drug or device within 30 days of the screening visit
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
  • Pregnant or nursing female or male with pregnant female partner
  • Current or prior history of clinical hepatic decompensation
  • History of clinically significant illness or any other major medical disorder that may have interfered with subject treatment, assessment or compliance with the protocol
  • Excessive alcohol ingestion or significant drug abuse

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：SOF+RBV+placebo
Participants were randomized to receive SOF+RBV for 12 weeks followed by placebo to match SOF plus placebo to match RBV for 4 weeks.
药品：SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
药品：Placebo to match SOF
Placebo to match SOF was administered orally once daily.
药品：Placebo to match RBV
Placebo to match RBV was administered orally twice daily.
实验性的：SOF+RBV
Participants were randomized to receive SOF+RBV for 16 weeks.
药品：SOF
Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
其他名称：
  • 索瓦尔迪®
  • GS-7977
  • PSI-7977
药品：RBV
Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

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 Achieving SVR12
大体时间：Posttreatment Week 12

SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ, ie, < 25 IU/mL) 12 weeks after cessation of therapy.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Posttreatment Week 12
Adverse Events Leading to Permanent Discontinuation of Study Drug
大体时间：Baseline to Week 16
Adverse events which led to permanent discontinuation of study drug may or may not have been related to study treatment.
Baseline to Week 16

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants Achieving SVR4
大体时间：Posttreatment Week 4

SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Posttreatment Week 4
Percentage of Participants Achieving SVR24
大体时间：Posttreatment Week 24

SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
大体时间：Up to 16 weeks

Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.

For the purposes of this efficacy analysis, assessments were made during active treatment (up to Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
Up to 16 weeks
Percentage of Participants With Viral Relapse
大体时间：End of treatment to posttreatment Week 24

Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.

For the purposes of this efficacy analysis, the posttreatment period began after the end of active treatment (following Week 12 for the SOF+RBV+placebo arm, and Week 16 for the SOF+RBV arm).
End of treatment to posttreatment Week 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

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

2012年6月1日

初级完成 (实际的)

2013年2月1日

研究完成 (实际的)

2013年5月1日

研究注册日期

首次提交

2012年5月21日

首先提交符合 QC 标准的

2012年5月22日

首次发布 (估计)

2012年5月24日

研究记录更新

最后更新发布 (估计)

2014年5月28日

上次提交的符合 QC 标准的更新

2014年5月9日

最后验证

2014年5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

  • GS-US-334-0108

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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