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

Janssen Pharmaceutical K.K.33 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C, Chronic

Interventions

AL-335DRUG

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (14)

Unnamed facility

Amagasaki-shi, Japan

Unnamed facility

Bunkyō City, Japan

Unnamed facility

Hiroshima, Japan

Unnamed facility

Kagoshima, Japan

Unnamed facility

Kurume-shi, Japan

Unnamed facility

Musashino-shi, Japan

Unnamed facility

Nagoya, Japan

Unnamed facility

Omura-shi, Japan

Unnamed facility

Osaka, Japan

Unnamed facility

Saitama, Japan

...and 4 more locations

Outcomes

Primary Outcomes

Number of Participants With Adverse Events (AEs)

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.

Time frame: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)

Secondary Outcomes

Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment

SVR4 was defined as hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) lower limit of quantification (LLOQ; 15 international unit per milliliter \[IU/mL\]) detected or not detected at 4 weeks after the actual End-of-treatment (EOT).

Time frame: Week 4 (follow-up phase)

Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment

SVR12 was defined as HCV RNA \< LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.

Time frame: Week 12 (follow-up phase)

Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment

SVR 24 was defined as HCV RNA \< LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.

Time frame: Week 24 (follow-up phase)

Percentage of Participants With Viral Relapse

Viral relapse was defined as participants who did not achieve SVR12, with HCV RNA \< LLOQ (15 IU/mL) at the EOT and confirmed HCV RNA greater than or equal to (\>=) LLOQ during follow-up.

Time frame: End of treatment up to Week 24 (follow up phase)

Percentage of Participants With On-treatment Failure

On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA \>= LLOQ (15 IU/mL) at the actual EOT.

Time frame: EOT up to Week 12 (follow up phase)

Percentage of Participants With On-treatment Virologic Response

Percentage of participants with On-treatment Virologic Response with HCV RNA \< LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.

Time frame: Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)

Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ

Time to Achieve HCV RNA not Detected or HCV RNA \<LLOQ (15 IU/mL) was reported.

Time frame: EOT up to Week 24 (follow up phase)