Clinical trial NCT02993250: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2016-12-15
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Approximately 38 weeks (Cohort 1) and 42 weeks (Cohort 2)
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks (SVR4) After Actual End-of-Treatment
timeFrame: Week 4 (follow-up phase)
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks (SVR12) After Actual End-of-treatment
timeFrame: Week 12 (follow-up phase)
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks (SVR24) After Actual End-of-treatment
timeFrame: Week 24 (follow-up phase)
measure: Percentage of Participants With Viral Relapse
timeFrame: End of treatment up to Week 24 (follow up phase)
measure: Percentage of Participants With On-treatment Failure
timeFrame: EOT up to Week 12 (follow up phase)
measure: Percentage of Participants With On-treatment Virologic Response
timeFrame: Day 2, Day 3, Week 1, 2, 3, 4, 6, 8 (for Cohort 1), 10, and 12 (for Cohort 2 only)
measure: Time to Achieve HCV RNA Not Detected or HCV RNA <LLOQ
timeFrame: EOT up to Week 24 (follow up phase)
Other outcomes:
Locations:
city: Amagasaki-shi
country: Japan
city: Bunkyo-ku
country: Japan
city: Hiroshima-shi
country: Japan
city: Kagoshima-shi
country: Japan
city: Kurume-shi
country: Japan
city: Musashino-shi
country: Japan
city: Nagoya-shi
country: Japan
city: Omura-shi
country: Japan
city: Osaka-shi
country: Japan
city: Saitama
country: Japan
city: Sakai-shi
country: Japan
city: Sapporo-shi
country: Japan
city: Suita-shi
country: Japan
city: Yokohama-shi
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K., Japan Clinical Trial
role: STUDY_DIRECTOR
References: