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-naive

Janssen Pharmaceutical K.K.0 个研究点目标入组 40 人开始时间: 待定

试验速览

暂无简介。

•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

•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

Number of Participants With Adverse Events (AE) as a Measure of Safety and Tolerability

Plasma Concentration of AL-335(Week 12 Follow-up Visit)
Plasma Concentration of Odalasvir (ODV)(Week 12 Follow-up Visit)
Plasma Concentration of Simeprevir (SMV)(Week 12 Follow-up Visit)
Percentage of Participants with Sustained Virologic Response 4 Weeks(SVR4)(4 weeks after End of Treatment (EOT))
Percentage of Participants with Sustained Virologic Response 12 Weeks(SVR12)(12 weeks after End of Treatment (EOT))
Percentage of Participants with Sustained Virologic Response 24 Weeks(SVR24)(24 weeks after End of Treatment (EOT))
Percentage of Participants With Viral Relapse(24 weeks after EOT)
Percentage of Participants With Ontreatment Failure(24 weeks after EOT)
Percentage of Participants With Ontreatment Virologic Response(24 weeks after EOT)
Time to Achieve HCV RNA not Detected or HCV RNA <LLOQ(24 weeks after EOT)

发起方