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A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

2017年4月21日 更新者：Hoffmann-La Roche

A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Telaprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

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)

80

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
    • British Columbia
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • Gordon & Leslie Diamond Health Care Centre; Dept. of Medicine - Division of Gastroenterology
      • Vancouver、British Columbia、加拿大、V6Z 2K5
        • GI Research Institute; Gastroenterology & Hepatology
      • Victoria、British Columbia、加拿大、V8V 3P9
        • PerCuro Clinical Research Ltd.
    • Manitoba
      • Winnipeg、Manitoba、加拿大、R3A 1R9
        • Winnipeg Regional Health Authority; Section of Hepatology
    • Ontario
      • Toronto、Ontario、加拿大、M5G 1L7
        • University Health Network - Toronto Western Hospital; Hepatology
      • Woodbridge、Ontario、加拿大、L4L 4Y7
        • Toronto Digest. Disease Asso.
    • Quebec
      • Montreal、Quebec、加拿大、H2X2P4
        • McGill University, Montreal Chest Institute; Viral and other Infectious
  • 德国
      • Frankfurt Am Main、德国、60590
        • Klinik Johann Wolfgang von Goethe Uni; Zentrum der Inneren Medizin; Medizinische Klinik I
      • Freiburg、德国、79106
        • Uniklinik Freiburg; Abteilung Innere Medizin II
      • Kiel、德国、24105
        • Universitäts Klinikum; Schleswig-Holstein Kiel
  • 意大利
    • Emilia-Romagna
      • Bologna、Emilia-Romagna、意大利、40138
        • UNI DEGLI STUDI - POLICLINICA S. ORSOLA; Dipartimento Malattie dell'Apparato Digerente e Medicina In
    • Lombardia
      • Milano、Lombardia、意大利、20162
        • ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA; Divisione Malattie Infettive
    • Toscana
      • Pisa、Toscana、意大利、56124
        • Ospedale Cisanello - Az. Osp. Pisana; Unità Operativa Di Gastroenterologia Ed Epatologia
  • 法国
      • Lille、法国、59037
        • Hopital Claude Huriez;Gastro Enterologie
      • Marseille、法国、13285
        • Fondation Hopital Saint Joseph; Gastro-Enterologie
      • Toulouse、法国、31059
        • Hopital Purpan;Gastro Enterologie Hepatologie
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35209
        • Birmingham Gastro Associates, P.C.
    • California
      • Long Beach、California、美国、90822
        • VA Long Beach Healthcare System
      • Sacramento、California、美国、95825
        • Kaiser Permanente Sacramento Medical Center
      • San Diego、California、美国、92103
        • UCSD Antiviral Research Center
    • Connecticut
      • New Haven、Connecticut、美国、06510
        • Yale University
    • Florida
      • Naples、Florida、美国、34102
        • Gastroenterology Group of Naples
    • Maryland
      • Lutherville、Maryland、美国、21093
        • John Hopkins Hospital
    • Massachusetts
      • Framingham、Massachusetts、美国、01702
        • MetroWest Medical Center
    • Missouri
      • Saint Louis、Missouri、美国、63104
        • Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
    • New York
      • New York、New York、美国、10021
        • Weill Cornell Medical College
    • North Carolina
      • Statesville、North Carolina、美国、28677
        • Carolina'S Center For Liver Disease
    • Ohio
      • Cincinnati、Ohio、美国、45267-0595
        • Uni of Cincinnati College of Medicine; Div. of Digestive Diseases
    • Texas
      • Dallas、Texas、美国、75246
        • Baylor Uni Medical Center; Division Of Hepatology/Transplantation; Annette C. and Harold C. Simmons
    • Virginia
      • Richmond、Virginia、美国、23249
        • McGuire; Veteran Affairs Med Ctr
    • Washington
      • Seattle、Washington、美国、98104
        • Harborview Medical Center
  • 英国
      • Dorset、英国、BH7 7DW
        • Royal Bournemouth Hospital, Gastroenterology
      • London、英国、SW17 0QT
        • St George's Hospital
      • London、英国、SE5 9RS
        • King'S College Hospital; Institute of Liver Studies
      • London、英国、W2 1NY
        • Imperial College Healthcare NHS Trust; Hepatology Clinical Research Facility
  • 西班牙
      • Barcelona、西班牙、08035
        • Hospital Universitari Vall d'Hebron; Departamento de Enfermedades Infecciosas
      • Barcelona、西班牙、08036
        • Hospital Clinic I Provincial; Servicio de Digestivo
      • Madrid、西班牙、28029
        • Hospital Carlos III; Laboratorio de Biologia Molecular
    • Tenerife
      • La Laguna、Tenerife、西班牙、38320
        • Hospital Universitario de Canarias; Servicio de Digestivo

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:

  • Chronic hepatitis C infection for at least 6 months duration
  • Hepatitis C genotype 1a or 1b
  • Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study
  • Participants showed a previous null response to therapy as defined by < 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

  • Hepatitis C infection with a genotype other than genotype 1a or 1b
  • Body mass index < 18 or >= 36 kilograms per square meters (kg/m^2)
  • Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection
  • Herbal remedies <=1 month prior to the first dose of study drug

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：双倍的

武器和干预

参与者组/臂
干预/治疗
实验性的：TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (24 Weeks)
Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV (total treatment duration of 24 weeks).
药品：Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
其他名称：
  • 眼镜蛇属
药品：Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
药品：Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
其他名称：
  • 飞马座
药品：Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
实验性的：TVR (12 Weeks), MCB (24 Weeks), PEG-IFN/RBV (48 Weeks)
Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with MCB and PEG-IFN/RBV and then 12 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
药品：Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
其他名称：
  • 眼镜蛇属
药品：Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
药品：Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
其他名称：
  • 飞马座
药品：Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
实验性的：TVR, MCB, Placebo MCB( each for 12Weeks),PEG-IFN/RBV(48 Weeks)
Twelve weeks of therapy with MCB, TVR, and PEG-IFN/RBV, followed by 12 weeks of therapy with placebo matching to MCB and PEG-IFN/RBV, and then 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
药品：Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
其他名称：
  • 眼镜蛇属
药品：Mericitabine
Participants will receive mericitabine 1000 mg orally twice daily.
药品：Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
其他名称：
  • 飞马座
药品：Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
药品：Placebo
Participants will receive placebo matching to mericitabine orally twice daily.
有源比较器：TVR(12 Weeks), Placebo MCB (24 Weeks), PEG-IFN/RBV(48 Weeks)
Twelve weeks of therapy with placebo matching to MCB, TVR, PEG-IFN/RBV, will be followed by 12 weeks of therapy with placebo matching to MCB along with PEG-IFN/RBV , following 24 weeks of therapy with PEG-IFN/RBV (total treatment duration of 48 weeks).
药品：Ribavirin
Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
其他名称：
  • 眼镜蛇属
药品：Peginterferon Alfa-2a
Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
其他名称：
  • 飞马座
药品：Telaprevir
Participants will receive telaprevir 750 mg orally three times daily.
药品：Placebo
Participants will receive placebo matching to mericitabine orally twice daily.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Percent of Participants With Sustained Virological Response 12 Weeks After End of Treatment (SVR12), as Determined by Polymerase Chain Reaction (PCR) Using Roche COBAS TaqMan Hepatitis C Virus (HCV) Test
大体时间：12 weeks after end of treatment (up to Week 60)
12 weeks after end of treatment (up to Week 60)

次要结果测量

结果测量
大体时间
Percentage of Participants With Sustained Virological Response 4 Weeks After End of Treatment (SVR-4), as Determined by PCR Using Roche COBAS TaqMan HCV Test
大体时间：4 weeks after end of treatment (up to Week 52)
4 weeks after end of treatment (up to Week 52)
Percentage of Participants With Sustained Virological Response 24 Weeks After End of Treatment (SVR-24), as Determined by PCR Using Roche COBAS TaqMan HCV Test
大体时间：24 weeks after end of treatment (up to Week 72)
24 weeks after end of treatment (up to Week 72)
Percentage of Participants With Virological Response Over Time From Week 2 to Week 48, as Determined by PCR Using Roche COBAS TaqMan HCV Test
大体时间：Weeks 2, 4, 12, 24, and 48
Weeks 2, 4, 12, 24, and 48
Percentage of Participants With Treatment- Resistant Mutations, as Determined Using Standard Sequencing Technology
大体时间：Baseline up to Week 60
Baseline up to Week 60
Change From Baseline in HCV Ribonucleic Acid (RNA) Levels
大体时间：Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
Baseline, Weeks 1, 2, 4, 8, 12, 16, 20, 24, 30, 36, 42, 48, 52, 60, and 72
Percentage of Participants With Adverse Event
大体时间：Baseline up to Week 72
Baseline up to Week 72
Trough Concentration of RO4995855 (Parent Drug of Mericitabine)
大体时间：Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Trough Concentration of Metabolite of RO4995855 (RO5012433)
大体时间：Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Trough Concentration of Telaprevir
大体时间：Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8
Pre-dose (-0.5 hour) on Day 1 and Week 8; 0, 0.5, 1, 2, 3, 4, 5, 6, 8, 12 hour post dose in Week 8

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

Hoffmann-La Roche

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)

2011年11月30日

初级完成 (实际的)

2014年1月31日

研究完成 (实际的)

2014年1月31日

研究注册日期

首次提交

2011年11月28日

首先提交符合 QC 标准的

2011年11月28日

首次发布 (估计)

2011年11月30日

研究记录更新

最后更新发布 (实际的)

2017年4月24日

上次提交的符合 QC 标准的更新

2017年4月21日

最后验证

2017年4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

  • NV27779
  • 2011-002715-28 (EudraCT编号)

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

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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