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

Hepatitis C, Chronic Clinical Trial

Official title:

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-naïve

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02993250
• Other study ID #: CR108264
• Secondary ID: 64294178HPC2003
• Status: Completed
• Phase: Phase 2
• Start date: December 21, 2016
• Est. completion date: May 7, 2018

Study information

• Verified date: September 2019
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 7, 2018
• Est. primary completion date: May 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Virus Diseases

Intervention

Drug:
• AL-335
Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
• Odalasvir (ODV)
Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
• Simeprevir (SMV)
Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
Secondary	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).	Week 4 (follow-up phase)
Secondary	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.	Week 12 (follow-up phase)
Secondary	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.	Week 24 (follow-up phase)
Secondary	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.	End of treatment up to Week 24 (follow up phase)
Secondary	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.	EOT up to Week 12 (follow up phase)
Secondary	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.	Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)
Secondary	Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ	Time to Achieve HCV RNA not Detected or HCV RNA	EOT up to Week 24 (follow up phase)