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Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

2017年4月26日 更新者：Bristol-Myers Squibb

Open-Label, Multiple-Dose, Dose Escalation Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Coadministration of BMS-650032, BMS-790052, and BMS-791325 When Administered for 24 or 12 Weeks in Treatment-Naïve Subjects Infected With Hepatitis C Virus Genotype 1

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA < LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 & Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

研究概览

地位

完全的

条件

干预/治疗

详细说明

IND numbers: 79,599; 101,943

研究类型

介入性

注册 (实际的)

320

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

  • 法国
      • Clichy Cedex、法国、92118
        • Local Institution
      • Creteil Cedex、法国、9410
        • Local Institution
      • Limoges、法国、87042
        • Local Institution
      • Marseille Cedex 08、法国、13285
        • Local Institution
      • Paris Cedex 14、法国、75679
        • Local Institution
  • 波多黎各
      • San Juan、波多黎各、00927
        • Fundacion De Investigacion de Diego
  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35294
        • The Kirklin Clinic
    • California
      • Coronado、California、美国、92118
        • Southern California Research Center
      • Los Angeles、California、美国、90073
        • VA Greater Los Angeles Healthcare System
      • Los Angeles、California、美国、90036
        • Peter J Ruane Md Inc
      • San Diego、California、美国、92105
        • Research and Education, Inc.
      • San Diego、California、美国、92123
        • Medical Associates Research Group
      • San Diego、California、美国、92114
        • Precision Research Institute, LLC
    • Colorado
      • Aurora、Colorado、美国、80045
        • University of Colorado Denver and Hospital
    • District of Columbia
      • Washington, D.C.、District of Columbia、美国、20007
        • MedStar Georgetown University Hospital
    • Florida
      • Orlando、Florida、美国、32803
        • Orlando Immunology Center
      • South Miami、Florida、美国、33143
        • Miami Research Associates
    • Georgia
      • Atlanta、Georgia、美国、30308
        • Atlanta Gastroenterology Associates, LLC
    • Maryland
      • Baltimore、Maryland、美国、21202
        • Mercy Medical Center, Inc.
      • Lutherville、Maryland、美国、21093
        • Johns Hopkins University
    • New Jersey
      • Hillsborough、New Jersey、美国、08844
        • ID care
    • New Mexico
      • Santa Fe、New Mexico、美国、87505
        • Southwest CARE Center
    • New York
      • The Bronx、New York、美国、10468
        • James J Peters VAMC
    • Oklahoma
      • Tulsa、Oklahoma、美国、74104
        • Options Health Research, LLC
      • Tulsa、Oklahoma、美国、74135
        • Healthcare Research Consultants
    • Texas
      • Arlington、Texas、美国、76012
        • Texas Clinical Research Institute
      • Houston、Texas、美国、77030
        • Research Specialists of Texas
      • San Antonio、Texas、美国、78215
        • Alamo Medical Research
    • Utah
      • Salt Lake City、Utah、美国、84106
        • Lifetree Clinical Research
    • Virginia
      • Fairfax、Virginia、美国、22031
        • Metropolitan Research
      • Falls Church、Virginia、美国、22042
        • INOVA Fairfax Hospital
    • Wisconsin
      • Madison、Wisconsin、美国、53715
        • Dean Clinic

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:

  • Men and women, ages ≥18 years of age
  • Subjects who are naive to HCV treatment, defined as no previous exposure to an Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or experimental therapy or subjects who are null responders to previous pegylated Interferon alfa (pegIFNα) plus Ribavirin (RBV) treatment

  • Subjects should have chronic hepatitis C (CHC) as documented by:

    1. Positive for anti-HCV antibody, HCV RNA, or a positive HCV genotype test at least 6 months prior to screening, and positive for HCV RNA and Anti-HCV antibody at the time of screening, or
    2. Positive for anti-HCV antibody and HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed prior to enrollment with evidence of CHC disease, such as the presence of fibrosis)
  • HCV genotype 1a, 1b or 4 only
  • HCV RNA viral load of ≥10,000 IU/mL at screening

  • Have one of the following:

    1. Documented Fibrotest score of ≤0.72 and aspartate transferase (transminase) to platelet ratio index (APRI) ≤2; OR
    2. Documented liver biopsy within 36 months preceding Day 1 showing absence of cirrhosis OR
    3. Documented Fibroscan® ultrasound (where approved) within 12 months of screening showing absence of cirrhosis
  • Body mass index (BMI) of 18.0 to 35.0 kg/m2, inclusive
  • Subjects with compensated Child-Pugh A cirrhosis as documented by history of cirrhosis with any prior liver biopsy or Fibroscan® ultrasound (where approved) within 12 months prior to screening

Exclusion Criteria:

  • Evidence of a medical condition associated with chronic liver disease other than HCV (such as but not limited to: hemochromatosis, autoimmune hepatitis,metabolic liver disease, alcoholic liver disease, toxin exposures)
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis
  • Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
  • Documented or suspected hepatocellular carcinoma (HCC)
  • Positive for hepatitis B surface antigen (HBsAg)
  • Positive for Human Immunodeficiency Virus-1 (HIV-1) and/or Human Immunodeficiency Virus-2 (HIV-2) antibodies
  • Alanine transferase (transminase) (ALT) >5x upper limit of normal (ULN)
  • Total Bilirubin ≥2 mg/dL

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：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Group 1:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 60 mg tablet by mouth once daily for 24 Weeks

BMS 791325 75 mg table by mouth twice daily for 24 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 2:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(75mg)

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 60 mg tablet by mouth once daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 3:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)

* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 60 mg tablet by mouth once daily for 24 Weeks

BMS 791325 150 mg table by mouth twice daily for 24 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 4:BMS-650032(200 mg)+BMS-790052(60 mg)+BMS-791325(150mg)

* Contingent upon review of safety data from all available treated subjects from Groups 1 and 2

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 60 mg tablet by mouth once daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 5:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 1 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 6:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 1 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 7:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 4 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 8:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 4 treatment-naive subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group 9:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 75 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group10:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 12 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 12 Weeks

BMS 791325 150 mg table by mouth twice daily for 12 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group11:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(75mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks

BMS 791325 75 mg table by mouth twice daily for 24 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Group12:BMS-650032(200 mg)+BMS-790052(30 mg)+BMS-791325(150mg)

* Genotype 1 treatment-null/non-responder subjects

BMS-650032 200 mg tablet by mouth twice daily for 24 Weeks

BMS-790052 30 mg tablet by mouth twice daily for 24 Weeks

BMS 791325 150 mg table by mouth twice daily for 24 Weeks
药品：BMS-791325
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)
实验性的：Grp13:BMS-650032(200mg)+BMS-790052(30mg)+BMS-791325(75mg)+RBV

* Genotype 1 treatment-naive subjects

BMS-650032 200 mg tablets orally twice daily 12 weeks

BMS-790052 30 mg tablets orally twice daily 12 weeks

BMS-791325 75 mg tablets orally twice daily 12 weeks

Ribavirin (RBV) tablets orally weight based dosing daily 12 weeks [if subject is < 75 kg: 1000 mg per day orally (2 x 200 mg tablets in AM and 3 x 200 mg tablets in PM), or if ≥ 75 kg: 1200 mg per day orally (3 x 200 mg tablets in AM and 3 x 200 mg tablets in PM]
药品：BMS-791325
药品：利巴韦林
其他名称：
  • 科佩格斯®
药品：BMS-650032
其他名称：
  • Asunaprevir (ASV)
药品：BMS-790052
其他名称：
  • Daclatasvir (DCV)

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Sustained virologic response (SVR) at 12 weeks post-treatment (SVR12)
大体时间：12 weeks post-treatment
12 weeks post-treatment

次要结果测量

结果测量
措施说明
大体时间
Proportion of subjects with HCV ribonucleic acid (RNA) < limit of quantification (LOQ) (detectable and undetectable)
大体时间：Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects with HCV ribonucleic acid (RNA) undetectable
大体时间：Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Weeks 1, 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22 and 24 weeks of therapy; at end of treatment (EOT) (following 12 or 24 weeks of treatment, by Group); and Weeks 4, 12, 24, 36, and 48 weeks post-treatment
Proportion of subjects who experience viral breakthrough
大体时间：Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)

viral breakthrough defined as:

  • Any increase in HCV RNA ≥ 1 log10 from nadir or
  • Any quantifiable HCV RNA ≥ 25 IU/mL (> LOQ) on or after Week 8
Formal analysis at SVR12, Week 48 of follow up period (or upon occurrence)
Proportion of subjects who experience viral relapse defined as confirmed quantifiable HCV RNA ≥ 25 IU/mL (>LOQ) in a subject with HCV RNA < LOQ or undetectable at End of treatment (EOT)
大体时间：End of treatment (Maximum up to 24 Weeks)
End of treatment (Maximum up to 24 Weeks)
Maximum observed plasma concentration (Cmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
大体时间：Day 1 and Day 14
Day 1 and Day 14
Observed plasma concentration at 12 hours (C12) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
大体时间：Day 1 and Day 14
Day 1 and Day 14
Observed plasma concentration at 24 hours (C24) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
大体时间：Day 1 and Day 14
Day 1 and Day 14
Trough observed plasma concentration (Ctrough) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
大体时间：Day 1 and Day 14
Day 1 and Day 14
Time of maximum observed plasma concentration (Tmax) of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
大体时间：Day 1 and Day 14
Day 1 and Day 14
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-650032, BMS-790052, BMS 791325, and BMS-794712
大体时间：Day 1 and Day 14
Day 1 and Day 14
HCV genomic substitutions associated with exposure of BMS-650032, BMS-790052, and BMS-791325
大体时间：At the time of viral breakthrough or relapse
At the time of viral breakthrough or relapse
Frequency of deaths, serious adverse events (SAEs), discontinuations due to adverse events (AEs), severity Grade 3/4 AEs, and severity Grade 3/4 laboratory abnormalities
大体时间：Formal analysis at week 48 of follow up period (or upon occurrence)
Formal analysis at week 48 of follow up period (or upon occurrence)

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

Bristol-Myers Squibb

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 (实际的)

2011年11月30日

初级完成 (实际的)

2014年3月31日

研究完成 (实际的)

2015年7月31日

研究注册日期

首次提交

2011年10月18日

首先提交符合 QC 标准的

2011年10月18日

首次发布 (估计)

2011年10月19日

研究记录更新

最后更新发布 (实际的)

2017年4月27日

上次提交的符合 QC 标准的更新

2017年4月26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

  • AI443-014
  • 2011-002788-11 (EudraCT编号)

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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