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
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT02993250
- Lead Sponsor
- Janssen Pharmaceutical K.K.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 (Chronic Hepatitis C Without Cirrhosis) Odalasvir (ODV) Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1. Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) AL-335 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). Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) Simeprevir (SMV) 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). Cohort 1 (Chronic Hepatitis C Without Cirrhosis) AL-335 Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1. Cohort 1 (Chronic Hepatitis C Without Cirrhosis) Simeprevir (SMV) Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1. Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis) Odalasvir (ODV) 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).
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Viral Relapse End of treatment up to Week 24 (follow up phase) 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.
Percentage of Participants With On-treatment Failure EOT up to Week 12 (follow up phase) On-treatment failure was defined as participants who did not achieve SVR12, with confirmed HCV RNA \>= LLOQ (15 IU/mL) at the actual EOT.
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 On-treatment Virologic Response with HCV RNA \< LLOQ (15 IU/mL), not detected at specified time points during treatment were reported.
Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment Week 4 (follow-up phase) 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).
Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment Week 12 (follow-up phase) SVR12 was defined as HCV RNA \< LLOQ (15 IU/mL) detected or not detected at 12 weeks after the actual EOT.
Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment Week 24 (follow-up phase) SVR 24 was defined as HCV RNA \< LLOQ (15 IU/mL) detected or not detected at 24 weeks after the actual EOT.
Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ EOT up to Week 24 (follow up phase) Time to Achieve HCV RNA not Detected or HCV RNA \<LLOQ (15 IU/mL) was reported.