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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 350
- 试验地点
- 18
- 主要终点
- Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
干预措施: PSI-7977 (Drug)
Treatment A: PSI-7977 + Daclatasvir
Genotype 1a or 1b
干预措施: Daclatasvir (Drug)
Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
干预措施: PSI-7977 (Drug)
Treatment B: PSI-7977 + Daclatasvir
Genotype 2 or 3
干预措施: Daclatasvir (Drug)
Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
干预措施: PSI-7977 (Drug)
Treatment C: PSI-7977 + Daclatasvir
Genotype 1a or 1b
干预措施: Daclatasvir (Drug)
Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
干预措施: PSI-7977 (Drug)
Treatment D: PSI-7977 + Daclatasvir
Genotype 2 or 3
干预措施: Daclatasvir (Drug)
Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
干预措施: PSI-7977 (Drug)
Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
干预措施: Daclatasvir (Drug)
Treatment E: PSI-7977 + Daclatasvir + Ribavirin
Genotype 1a or 1b
干预措施: Ribavirin (Drug)
Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
干预措施: PSI-7977 (Drug)
Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
干预措施: Daclatasvir (Drug)
Treatment F: PSI-7977 + Daclatasvir+ Ribavirin
Genotype 2 or 3
干预措施: Ribavirin (Drug)
Treatment G: PSI-7977 + Daclatasvir
Hepatitis C virus genotype 1, treatment-naive patients
Genotype 1a or 1b
干预措施: PSI-7977 (Drug)
Treatment G: PSI-7977 + Daclatasvir
Hepatitis C virus genotype 1, treatment-naive patients
Genotype 1a or 1b
干预措施: Daclatasvir (Drug)
Treatment H: PSI-7977 + BMS-790052 + Ribavirin
Hepatitis C virus genotype 1, treatment-naive patients
Genotype 1a or 1b
干预措施: PSI-7977 (Drug)
Treatment H: PSI-7977 + BMS-790052 + Ribavirin
Hepatitis C virus genotype 1, treatment-naive patients
Genotype 1a or 1b
干预措施: Daclatasvir (Drug)
Treatment H: PSI-7977 + BMS-790052 + Ribavirin
Hepatitis C virus genotype 1, treatment-naive patients
Genotype 1a or 1b
干预措施: Ribavirin (Drug)
Treatment I: PSI-7977 + Daclatasvir
Patients who experienced telaprevir/boceprevir treatment failure
Genotype 1a or 1b
干预措施: PSI-7977 (Drug)
Treatment I: PSI-7977 + Daclatasvir
Patients who experienced telaprevir/boceprevir treatment failure
Genotype 1a or 1b
干预措施: Daclatasvir (Drug)
Treatment J: PSI-7977 + Daclatasvir + Ribavirin
Patients who experienced telaprevir/boceprevir treatment failure
Genotype 1a or 1b
干预措施: PSI-7977 (Drug)
Treatment J: PSI-7977 + Daclatasvir + Ribavirin
Patients who experienced telaprevir/boceprevir treatment failure
Genotype 1a or 1b
干预措施: Daclatasvir (Drug)
Treatment J: PSI-7977 + Daclatasvir + Ribavirin
Patients who experienced telaprevir/boceprevir treatment failure
Genotype 1a or 1b
干预措施: Ribavirin (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
时间窗: 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.
次要结局
- Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)(Follow-up Week 24)
- 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(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))
- Percentage of Participants With Viral Breakthrough During the Treatment Period(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(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(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(First dose of study drug (Day 1) up to the start of rescue therapy (12 or 24 weeks, depending on treatment group))