A Phase 2a, Multicenter, Open-label Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Subjects With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naïve
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)-naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis C virus (HCV) infection
- •All participants must have HCV genotype 1 or 2 infection, determined at screening
- •HCV ribonucleic acid (RNA) plasma levels greater than or equal to (>=)10,000 international units per Milliliter (IU/mL), determined at screening
- •Direct-acting antiviral (DAA)-naive participants, defined as not having received treatment with any approved or investigational DAA drug for chronic HCV infection; prior HCV therapy consisting of interferon (IFN, pegylated or nonpegylated) with or without ribavirin (RBV) is allowed
- •Participants without cirrhosis or with compensated cirrhosis
排除标准
- •Infection with HCV genotype - 3, 4, 5, or 6
- •Co-infection with human immunodeficiency virus (HIV 1 or HIV 2 antibody positive) or hepatitis B virus (HBV) (hepatitis B surface antigen [HBsAg] positive)
- •Prior treatment with any investigational or approved HCV DAA, either in combination with PegIFN or IFN free
- •Any evidence of liver disease of non-HCV etiology. This includes, but is not limited to, acute hepatitis A infection (immunoglobulin M), drug or alcohol related liver disease, autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha 1 antitrypsin deficiency, primary biliary cirrhosis, or any other non-HCV liver disease that is considered clinically significant by the investigator
- •Evidence of hepatic decompensation as assessed with Child-Pugh Class B or C or any of the following: history or current clinical evidence of ascites, bleeding varices, or hepatic encephalopathy
研究组 & 干预措施
Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
干预措施: AL-335 (Drug)
Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
干预措施: Odalasvir (ODV) (Drug)
Cohort 1 (Chronic Hepatitis C Without Cirrhosis)
Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.
干预措施: Simeprevir (SMV) (Drug)
Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).
干预措施: AL-335 (Drug)
Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).
干预措施: Odalasvir (ODV) (Drug)
Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)
Participants will receive AL-335 800 milligram (mg)+ODV 25 mg+SMV 75 mg once daily for 12 weeks in Cohort 2. Dosing in cohort 2 will be started according to decision of Data Review Committee (DRC).
干预措施: Simeprevir (SMV) (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
An adverse event was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
次要结局
- Percentage of Participants With Viral Relapse(End of treatment 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 On-treatment Virologic Response(Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only))
- Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment(Week 4 (follow-up phase))
- Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment(Week 12 (follow-up phase))
- Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment(Week 24 (follow-up phase))
- Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ(EOT up to Week 24 (follow up phase))