A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 365
- 主要终点
- Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
详细描述
This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.
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
- •Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
- •Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
- •Absence of cirrhosis
- •Screening laboratory values within defined thresholds
- •Must use specific contraceptive methods if female of childbearing potential or sexually active male
排除标准
- •Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
- •Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
- •Current or prior history of clinical hepatic decompensation
- •History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
- •Pregnant or a nursing female
研究组 & 干预措施
Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
干预措施: AL-335 (Drug)
Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
干预措施: Odalasvir (Drug)
Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
干预措施: Simeprevir (Drug)
Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
干预措施: AL-335 (Drug)
Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
干预措施: Odalasvir (Drug)
Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
干预措施: Simeprevir (Drug)
结局指标
主要结局
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
时间窗: Week 12 (Follow-Up Phase)
The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detectable or undetectable 12 weeks after actual EOT.
次要结局
- Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)(Week 24 (Follow-Up Phase))
- Number of Participants With Viral Relapse(End of Treatment up to Week 24 (Follow up phase))
- Number of Participants With Late Viral Relapse(Up to Week 24 (Follow-up Phase))
- Percentage of Participants With On-treatment Failure(EOT up to Week 12 (Follow up Phase))
- Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)(Week 4 (Follow-Up Phase))