A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Intervention: AL-335; Odalasvir (ODV); Simeprevir (SMV)
Intervention description: Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.; Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
Intervention MeSH terms: Simeprevir; Odalasvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 33.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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