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

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

Sponsors

Lead sponsor: Janssen Pharmaceutical K.K.

Source 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.

Overall Status Completed
Start Date December 21, 2016
Completion Date May 7, 2018
Primary Completion Date May 7, 2018
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Number of Participants With Adverse Events (AEs) Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
Secondary Outcome
Measure Time Frame
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)
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)
Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ EOT up to Week 24 (follow up phase)
Enrollment 33
Condition
Intervention

Intervention type: Drug

Intervention name: AL-335

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

Other name: JNJ-64146212

Intervention type: Drug

Intervention name: Odalasvir (ODV)

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

Other name: JNJ-64289901

Intervention type: Drug

Intervention name: Simeprevir (SMV)

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

Other name: TMC435

Eligibility

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:

- 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

Gender: All

Minimum age: 20 Years

Maximum age: 75 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Janssen Pharmaceutical K.K., Japan Clinical Trial Study Director Janssen Pharmaceutical K.K.
Location
facility
| Amagasaki-shi, Japan
| Bunkyo-ku, Japan
| Hiroshima-shi, Japan
| Kagoshima-shi, Japan
| Kurume-shi, Japan
| Musashino-shi, Japan
| Nagoya-shi, Japan
| Omura-shi, Japan
| Osaka-shi, Japan
| Saitama, Japan
| Sakai-shi, Japan
| Sapporo-shi, Japan
| Suita-shi, Japan
| Yokohama-shi, Japan
Location Countries

Japan

Verification Date

September 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Cohort 1 (Chronic Hepatitis C Without Cirrhosis)

Arm group type: Experimental

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

Arm group label: Cohort 2 (Chronic Hepatitis C With Compensated Cirrhosis)

Arm group type: Experimental

Description: 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).

Study Design Info

Allocation: Non-Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov