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Japanese Pegylated Interferon (PegIFN) Alfa-2b/Ribavirin (RBV) Combination Trial

2015年7月3日 更新者：Boehringer Ingelheim

Safety, Efficacy and Pharmacokinetics of BI 201335 NA in Patient With Genotype 1 Chronic Hepatitis C Virus Infection in Combination With Pegylated Interferon Alfa-2b and Ribavirin - Cohort 1 for Treatment-naive Patients: Randomised, Double-blind Part of BI 201335 NA for 12 or 24 Weeks - Cohort 2 for Treatment-experienced Patients: Open-label Part of BI 201335 NA for 24 Weeks

The aim of this trial is to evaluate the safety and efficacy of BI 201335 given for 12 or 24 weeks in combination with PegIFN alfa-2b/RBV given for 24 or 48 weeks in chronic genotype 1 hepatitis C virus infected treatment-naïve and treatment-experienced Japanese patients

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)

131

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

  • 日本
      • Chuo-ku, Chiba、日本
        • 1220.54.08104 Boehringer Ingelheim Investigational Site
      • Chuo-ku, Kobe, Hyogo、日本
        • 1220.54.08118 Boehringer Ingelheim Investigational Site
      • Fukui, Fukui、日本
        • 1220.54.08108 Boehringer Ingelheim Investigational Site
      • Gifu, Gifu、日本
        • 1220.54.08110 Boehringer Ingelheim Investigational Site
      • Itabashi-ku, Tokyo、日本
        • 1220.54.08105 Boehringer Ingelheim Investigational Site
      • Izunokuni, Shizuoka、日本
        • 1220.54.08112 Boehringer Ingelheim Investigational Site
      • Kanazawa, Ishikawa、日本
        • 1220.54.08107 Boehringer Ingelheim Investigational Site
      • Kita-gun, Kagawa、日本
        • 1220.54.08120 Boehringer Ingelheim Investigational Site
      • Kofu, Yamanashi、日本
        • 1220.54.08109 Boehringer Ingelheim Investigational Site
      • Kurume, Fukuoka、日本
        • 1220.54.08123 Boehringer Ingelheim Investigational Site
      • Mtsuyama, Ehime、日本
        • 1220.54.08121 Boehringer Ingelheim Investigational Site
      • Nagoya, Aichi、日本
        • 1220.54.08113 Boehringer Ingelheim Investigational Site
      • Nishinomiya, Hyogo、日本
        • 1220.54.08117 Boehringer Ingelheim Investigational Site
      • Ogaki, Gifu、日本
        • 1220.54.08111 Boehringer Ingelheim Investigational Site
      • Oo mura, Nagasaki,、日本
        • 1220.54.08124 Boehringer Ingelheim Investigational Site
      • Osaka, Osaka、日本
        • 1220.54.08115 Boehringer Ingelheim Investigational Site
      • Osakasayama, Osaka、日本
        • 1220.54.08116 Boehringer Ingelheim Investigational Site
      • Sapporo, Hokkaido、日本
        • 1220.54.08101 Boehringer Ingelheim Investigational Site
      • Sendai, Miyagi、日本
        • 1220.54.08102 Boehringer Ingelheim Investigational Site
      • Tanabe, Wakayama、日本
        • 1220.54.08119 Boehringer Ingelheim Investigational Site
      • Toyama,Toyama、日本
        • 1220.54.08106 Boehringer Ingelheim Investigational Site
      • Tsu, Mie、日本
        • 1220.54.08114 Boehringer Ingelheim Investigational Site
      • Yahatanishi-ku, Kitakyusyu, Fukuoka、日本
        • 1220.54.08122 Boehringer Ingelheim Investigational Site
      • Yamagata, Yamagata、日本
        • 1220.54.08125 Boehringer Ingelheim Investigational Site

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

20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:

  1. Chronic hepatitis C infection, diagnosed by positive anti-HCV antibodies and detected HCV RNA at screening in addition to:

    • positive anti-HCV antibodies or detected HCV RNA at least 6 months before screening; or,
    • liver biopsy consistent with chronic HCV infection.
  2. HCV genotype 1 infection confirmed by genotypic testing at screening
  3. (For Cohort 1 only) Therapy-naïve to interferon, pegylated interferon, and ribavirin (For Cohort 2 only) Confirmed prior virological failure (null response, partial response, breakthrough or relapse) with an approved dose of PegIFN alfa/RBV or IFN beta/RBV for at least 12 weeks and with an 8-week washout period before screening
  4. HCV RNA = 100,000 IU/mL at screening
  5. Documentation of a liver biopsy within 3 years or fibroscan within 6 months before randomization (Visit 2)
  6. Age 20 to 70 years

  7. Female patients who are infertile or who are of childbearing potential with a negative pregnancy test and agreeing to use one accepted method of birth control in addition to the use of a condom by their male partners.

    or Male patients who are infertile, who are without pregnant female partners or who consistently and correctly use condoms.

  8. Signed informed consent form before trial participation

Exclusion criteria:

  1. HCV infection of mixed genotype (1/2, 1/3, and 1/4) diagnosed by genotypic testing at screening,
  2. Evidence of acute or chronic liver disease due to causes other than chronic HCV infection. Steatosis diagnosed incidentally (e.g. by biopsy) without clinical relevance is not an exclusion criterion.
  3. HIV co-infection,
  4. Hepatitis B virus (HBV) infection based on presence of hepatitis B surface antigen (HBsAg),
  5. Active malignancy, or history of malignancy within the last 5 years prior to screening (with an exception of appropriately treated basal cell carcinoma of the skin or in situ carcinoma of the uterine cervix),
  6. Active or, history of alcohol or illicit drug abuse within the past 12 months,
  7. A condition that is defined as one which in the opinion of investigator may put the patient at risk because of participation in this study, may influence the results of this study, or limit the patient's ability to participate in this study,
  8. Usage of any investigational drugs within 30 days prior to screening, or planned usage of an investigational drug during the course of this study,
  9. Received concomitant systemic antiviral, hematopoietic growth factor, or immunomodulatory treatment within 30 days prior to screening. Patients being treated with oral antivirals such as acyclovir, famciclovir or valacyclovir for recurrent herpes simplex infection; or with oseltamivir or zanamivir for influenza A infection, may be screened,
  10. Received silymarin (milk thistle), glycyrrhizin (Stronger Neo-Minophagen C; SNMC), or Sho-saiko-to (SST) within 28 days prior to randomization (Visit 2) and throughout the treatment phase of this trial,
  11. (For Cohort 2 only) Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than (pegylated) interferon alfa, interferon beta or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
  12. Known hypersensitivity to any ingredient of the study drugs,
  13. Alpha fetoprotein value >100 ng/mL at screening; if >20 ng/mL and =100 ng/mL, patients may be included if there is no evidence of liver cancer in an appropriate imaging study (e.g., ultrasound, CT scan, or MRI) within last 6 months prior to randomization (Visit 2),

Other exclusion criteria related to pegylated interferon and/or ribavirin restrictions are not listed here.

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：1. BI 201335 low dose plus PegIFN/RBV
low dose BI 201335 NA once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
药品：BI 201335 low dose
BI 201335 low dose with PegIFN/RBV
实验性的：2. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 12 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-naive patients
药品：BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
实验性的：3. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients
药品：BI 201335 high dose
BI 201335 high dose with PegIFN/RBV
实验性的：4. BI 201335 high dose plus PegIFN/RBV
high dose BI 201335 NA once daily for 24 weeks combined with PegIFN/RBV for 48 weeks in treatment-experienced (null responder, partial responder, breakthrough) patients
药品：BI 201335 high dose
BI 201335 high dose with PegIFN/RBV

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
Number of Patients With Investigator Defined Drug-related Adverse Events
大体时间：Up to 52 weeks
Drug-related AEs were defined as those whose causal relationship with any one of the investigational products was considered by the investigator.
Up to 52 weeks

次要结果测量

结果测量
措施说明
大体时间
Sustained Virological Response (SVR12), Defined as Plasma HCV RNA Undetectable at 12 Weeks After End of Treatment (EOT)
大体时间：EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
Plasma hepatitis C virus (HCV) ribonucleic acid (RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration
EOT (up to Week 24 or 48) and 12 weeks after the EOT (up to Week 36 or 60)
Sustained Virological Response (SVR24), Defined as Plasma HCV RNA Undetectable at 24 Weeks After End of Treatment (EOT)
大体时间：EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
Plasma HCV RNA level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration
EOT (up to Week 24 or 48) and 24 weeks after the EOT (up to Week 48 or 72)
Early Treatment Success (ETS), Defined as Plasma HCV RNA <25 IU/mL at Week 4 and HCV RNA Undetectable at Week 8
大体时间：up to 8 weeks
Plasma HCV RNA level <25 IU/mL (detected or undetected) at Week 4 and HCV RNA <25 IU/mL (undetected) at Week 8
up to 8 weeks
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12=YES
大体时间：EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at End of Treatment (EOT) When SVR12= NO
大体时间：EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
大体时间：12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)
Alanine Aminotransferase (ALT) Normalisation: ALT in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
大体时间：12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=YES
大体时间：EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at End of Treatment (EOT) When SVR12=NO
大体时间：EOT (up to Week 24 or 48)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
EOT (up to Week 24 or 48)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=YES
大体时间：12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)
Aspartate Aminotransferase (AST) Normalisation: AST in Normal Range at Sustained Virological Response 12 Weeks Post-treatment (SVR12) Visit, When SVR12=NO
大体时间：12 weeks after the EOT (up to Week 36 or 60)
This will be presented as the number of patients. SVR12 means Sustained virological response 12 weeks post-treatment. BL = Baseline
12 weeks after the EOT (up to Week 36 or 60)

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

Boehringer Ingelheim

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

有用的网址

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4月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2012年4月12日

首先提交符合 QC 标准的

2012年4月17日

首次发布 (估计)

2012年4月18日

研究记录更新

最后更新发布 (估计)

2015年8月3日

上次提交的符合 QC 标准的更新

2015年7月3日

最后验证

2015年7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

  • 1220.54

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