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

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

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223413

Enrollment

Registered

2016-12-16

Start date

2016-12-16

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Interventions

investigational material(s) Generic name etc : AL-335 INN of investigational material : Therapeutic category code : 625 Anti-virus agents Dosage and Administration for Investigational material : Part

Eligibility

Sex/Gender

All

Inclusion 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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026