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Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

2015年9月23日 更新者：Bristol-Myers Squibb

Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

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)

350

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

  • 波多黎各
      • San Juan、波多黎各、00927
        • Local Institution
  • 美国
    • California
      • Coronado、California、美国、92118
        • Southern California Liver Centers
      • San Diego、California、美国、92105
        • Research and Education, Inc.
    • Colorado
      • Aurora、Colorado、美国、80045
        • University Of Colorado Denver & Hospital
    • Florida
      • Gainesville、Florida、美国、32610
        • University Of Florida Hepatology
      • Orlando、Florida、美国、32803
        • Orlando Immunology Center
      • South Miami、Florida、美国、33143
        • Miami Research Associates
    • Maryland
      • Baltimore、Maryland、美国、21202
        • Mercy Medical Center
      • Lutherville、Maryland、美国、21093
        • Johns Hopkins University
    • Michigan
      • Ann Arbor、Michigan、美国、48109
        • University of Michigan Health System
    • New York
      • Bronx、New York、美国、10468
        • Bronx Va Medical Center 3c Sub-J
      • New York、New York、美国、10021
        • Weill Cornell Medical College
    • Oklahoma
      • Tulsa、Oklahoma、美国、74104
        • Options Health Research, LLC
      • Tulsa、Oklahoma、美国、74135
        • Healthcare Research Consultants
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104
        • University of Pennsylvania
    • Texas
      • San Antonio、Texas、美国、78215
        • Alamo Medical Research
    • Virginia
      • Annandale、Virginia、美国、22003
        • Metropolitan Research
    • 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 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:

  • Men and women, ages 18 to 70 years.
  • Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no previous exposure to an interferon formulation (ie, interferon-alpha, pegylated interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including daclatasvir and PSI-7977).
  • Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by: positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6 months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

Exclusion Criteria:

  • Evidence of a medical condition associate with chronic liver disease other than HCV.
  • History of variceal bleeding, hepatic encephalopathy, or ascites requiring management with diuretics or paracentesis.
  • History of hemophilia.
  • History of torsade de pointes.
  • 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.
  • History of gastrointestinal disease or surgical procedure (except cholecystectomy).
  • History of clinically significant cardiac disease.
  • Blood transfusion within 4 weeks prior to study drug administration.
  • Poor venous access.
  • Any other medical, psychiatric, and/or social reason which, in the opinion of the Investigator, would make the candidate inappropriate for participation in this study.

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：Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
实验性的：Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
实验性的：Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
实验性的：Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
实验性的：Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
药品：Ribavirin
Tablets, oral, 200 mg
其他名称：
  • Copegus ®
实验性的：Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
药品：Ribavirin
Tablets, oral, 200 mg
其他名称：
  • Copegus ®
实验性的：Treatment G: PSI-7977 + Daclatasvir

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
实验性的：Treatment H: PSI-7977 + BMS-790052 + Ribavirin

Hepatitis C virus genotype 1, treatment-naive patients

Genotype 1a or 1b
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
药品：Ribavirin
Tablets, oral, 200 mg
其他名称：
  • Copegus ®
实验性的：Treatment I: PSI-7977 + Daclatasvir

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
实验性的：Treatment J: PSI-7977 + Daclatasvir + Ribavirin

Patients who experienced telaprevir/boceprevir treatment failure

Genotype 1a or 1b
药品：PSI-7977
Tablets, oral, 400 mg, once daily
药品：Daclatasvir
Tablets, oral, 60 mg, once daily
其他名称：
  • BMS-790052
药品：Ribavirin
Tablets, oral, 200 mg
其他名称：
  • Copegus ®

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 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
大体时间：Follow-up Week 12
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA <25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 12

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
大体时间：Follow-up Week 24
SVR24 was defined as participant's hepatitis C virus RNA less than the lower limit of quantitation, target detected or target not detected at follow-up Week 24. DCV=daclatasvir, SOF=sofosbuvir.
Follow-up Week 24
Percentage of Participants With Viral Breakthrough During the Treatment Period
大体时间：First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Viral breakthrough is defined as any confirmed increase in viral load ≥1 log from nadir or any confirmed hepatitis C virus RNA levels ≥25 IU/mL on or after Week 8.
First dose of study drug (Day 1) up to end of treatment period (up to 12 or 24 weeks, depending on treatment group)
Percentage of Participants Who Experienced Viral Relapse During Follow-up Period
大体时间：Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Viral relapse during follow-up is defined as any confirmed quantifiable hepatitis C virus (HCV) RNA ≥25 IU/mL with HCV RNA levels less than the lower limit of quantitation, target detected or target not detected, ie, HCV RNA <25 IU/mL at the end of treatment.
Day 1 of follow-up period (Week 13 or 25, depending on treatment group) to end of follow-up period (up to 48 weeks)
Change From Baseline in log10 Hepatitis C Virus (HCV) RNA at Follow-up Week 24
大体时间：Baseline, Follow-up week 24
Change from baseline in log10 HCV RNA at scheduled sampling time.
Baseline, Follow-up week 24
Number of Participants Who Died and With Serious Adverse Events (SAEs) and Grade 3-4 Adverse Events (AEs), During the Treatment Period Prior to Addition of Rescue Therapy
大体时间：First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe.
First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group)
Number of Participants Who Died and With Serious Adverse Events (SAEs), Grade 3-4 Adverse Events (AEs), and Grade 3-4 Abnormalities on Laboratory Test Results During Follow-up Period
大体时间：AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization. Based on the severity, AEs were categorized as Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Very severe
AEs: From Day 1 of follow-up period (Week 13 or 25) up to study discharge (up to 72 weeks). SAEs: From Day 1 of follow-up period (Week 13 or 25) up to 30 days after study discharge (up to 74 weeks)

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

合作者

Pharmasset

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

2011年6月1日

初级完成 (实际的)

2013年1月1日

研究完成 (实际的)

2013年10月1日

研究注册日期

首次提交

2011年5月23日

首先提交符合 QC 标准的

2011年5月24日

首次发布 (估计)

2011年5月25日

研究记录更新

最后更新发布 (估计)

2015年10月23日

上次提交的符合 QC 标准的更新

2015年9月23日

最后验证

2015年9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

  • AI444-040

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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PSI-7977的临床试验

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医疗条件

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条件

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赞助者/合作者

地点

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