A Phase 2a Study of PPI-668 in Combination With BI 207127 and Faldaprevir, With and Without Ribavirin, in Treatment-Naive Patients With Chronic Hepatitis C (HCV Genotype 1a)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- the proportion of patients achieving sustained viral response (SVR)
研究概览
简要总结
This study is designed to provide a preliminary assessment of the safety and effectiveness of the combination of PPI-668, BI 207127 and faldaprevir, with or without ribavirin, in the treatment of chronic hepatitis C virus infection.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 65 years of age; if females are of childbearing potential, then they must be willing to use two non-hormonal methods of birth control
- •Body weight greater than 40 kg and less than 125 kg
- •Clinical diagnosis of chronic hepatitis C
- •Treatment-naïve for hepatitis C: no previous treatment with interferon, pegylated interferon, ribavirin, telaprevir, boceprevir, or any investigational therapies for hepatitis C
- •No symptoms or signs of intercurrent illness at Screen (other than those attributable to hepatitis C)
- •No clinically significant abnormalities in the 12-lead electrocardiogram at Screen
- •Signed informed consent prior to trial participation.
排除标准
- •Seropositive for HIV antibody or Hepatitis B Surface Antigen at Screen
- •Liver disease due to causes other than chronic HCV infection
- •Symptoms or signs of decompensated liver disease, or evidence of cirrhosis
- •Any medical condition that may interfere with the absorption, distribution or elimination of study drugs
- •Poorly controlled or unstable hypertension at Screen.
- •Clinically significant, unstable cardiovascular or pulmonary disease, including cardiovascular or pulmonary disease requiring pharmacologic intervention other than anti-hypertensive medications, statins, and/or prophylactic aspirin (or similar anticoagulant).
- •Red blood cell disorder, including (but not limited to): thalassemia major or minor, sickle cell anemia.
- •Diabetes Mellitus treated with insulin or hypoglycemic agents
- •History of asthma requiring hospital admission within the preceding 12 months
- •History of alcohol abuse or illicit drug use which could interfere with a patient's compliance with the protocol requirements, or with the safety or efficacy assessments in this study
- •Patients requiring treatment, during this study, with any of the medications on the restricted medications list (provided in the investigator site file), are not eligible for this study due to considerations of possible drug interactions with the study drug regimen.
研究组 & 干预措施
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
干预措施: PPI-668 (Drug)
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
干预措施: BI 207127 Dose 1 (Drug)
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
干预措施: Faldaprevir (Drug)
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 1, Faldaprevir, and Ribavirin dosed in combination
干预措施: Ribavirin (Drug)
PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
干预措施: PPI-668 (Drug)
PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
干预措施: BI 207127 Dose 2 (Drug)
PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
干预措施: Faldaprevir (Drug)
PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
干预措施: Ribavirin (Drug)
PPI-668, BI 207127 Dose 2, Faldaprevir, and Ribavirin
PPI-668, BI 207127 Dose 2, BI 207127 Placebo, Faldaprevir, and Ribavirin dosed in combination
干预措施: BI 207127 Placebo (Drug)
PPI-668, BI 207127 Dose 1, and Faldaprevir
PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination
干预措施: PPI-668 (Drug)
PPI-668, BI 207127 Dose 1, and Faldaprevir
PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination
干预措施: BI 207127 Dose 1 (Drug)
PPI-668, BI 207127 Dose 1, and Faldaprevir
PPI-668, BI 207127 Dose 1, and Faldaprevir dosed in combination
干预措施: Faldaprevir (Drug)
结局指标
主要结局
the proportion of patients achieving sustained viral response (SVR)
时间窗: 12 weeks after the end of treatment
次要结局
- Proportion of patients with "virologic relapse" post-treatment, defined as confirmed and quantifiable (>LLOQ) serum HCV RNA in a patient who achieved non-detectable serum HCV RNA by the end of treatment(up to 24 weeks post-treatment)
- Proportion of patients with confirmed viral breakthrough during study treatment(up to 12 weeks of study treatment)
- Proportions of study participants who receive at least one dose of study drug and who prematurely discontinue study treatment, and proportions prematurely discontinuing treatment for clinical adverse events or laboratory abnormalities(up to 12 weeks of study treatment)
- Proportions of study participants experiencing treatment-emergent adverse events (serious and non-serious) considered to be possibly or probably attributable to study treatment, overall and by body system(up to 12 weeks of study treatment)