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

NCT02993250 | Completed Phase 2 Results

• 2 other identifiers: CR10826464294178HPC2003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 14

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.

Conditions

Hepatitis C, Chronic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  Week 4 (follow-up phase)

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

  Week 12 (follow-up phase)

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

  Week 24 (follow-up phase)

• Percentage of Participants With Viral Relapse

  End of treatment up to Week 24 (follow up phase)

• Percentage of Participants With On-treatment Failure

  EOT up to Week 12 (follow up phase)

Study Arms (2)

Cohort 1 (Chronic Hepatitis C Without Cirrhosis)

EXPERIMENTAL

Participants will receive 800 milligram (mg) AL-335 +odalasvir (ODV) 25 mg+simeprevir (SMV) 75 mg once daily for 8 weeks in Cohort 1.

Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)

Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)

EXPERIMENTAL

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).

Drug: AL-335; Drug: Odalasvir (ODV); Drug: Simeprevir (SMV)

Interventions

AL-335 DRUG

Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

Also known as: JNJ-64146212

Cohort 1 (Chronic Hepatitis C Without Cirrhosis); Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)

Odalasvir (ODV) DRUG

Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

Also known as: JNJ-64289901

Cohort 1 (Chronic Hepatitis C Without Cirrhosis); Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)

Simeprevir (SMV) DRUG

Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.

Also known as: TMC435

Cohort 1 (Chronic Hepatitis C Without Cirrhosis); Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (14)

Unknown Facility

Amagasaki-shi, Japan

Location

Unknown Facility

Bunkyō City, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kurume-shi, Japan

Location

Unknown Facility

Musashino-shi, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Omura-shi, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Sakaishi, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Suita-shi, Japan

Location

Unknown Facility

Yokohama, Japan

Location

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

adafosbuvir; odalasvir; Simeprevir

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

As the sponsor decided to discontinue the development of JNJ-64294178, the study enrollment to reach the target number of participants was not completed in Cohort 2.

Results Point of Contact

• Title: Clinical Leader
• Organization: Janssen Pharmaceutical K.K., Japan

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2016
• First Posted: December 15, 2016
• Study Start: December 21, 2016
• Primary Completion: May 7, 2018
• Study Completion: May 7, 2018
• Last Updated: September 11, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-09

Locations

JP (14)