A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants With Advanced Liver Disease

Phase 1

Conditions: Hepatitis C Virus (HCV) genotype-1b Infection
MedDRA version: 17.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Diseases [C] - Virus Diseases [C02]

Registration Number: EUCTR2014-003413-28-ES

Lead Sponsor: Janssen-Cilag International NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 110

Inclusion Criteria

- Participant must have chronic Hepatitis C virus (HCV) genotype 1b infection confirmed at Screening
- Participant must have HCV ribonucleic acid (RNA) greater than (>) 10,000 international unit per milliliter (IU/mL) at Screening - Participant must have documented advanced fibrosis or compensated liver cirrhosis at Screening (METAVIR F3 or F4)
- Participants who have cirrhosis must have an hepatic imaging procedure (ultrasound, computed tomography [CT] scan or magnetic resonance imaging [MRI]) within 6 months prior to the Screening visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma
- Participant must have a body mass index (BMI) greater than or equal to (>=) 18 Kilogram per meter^2 (kg/m^2)
- Participant must be treatment naive (that is, have not received prior treatment for HCV with any approved or investigational drug)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Participant has co-infection with HCV of a genotype other than genotype 1b
- Participant has the presence of genetic variants coding for the NS5A-Y93H and/or L31M/V amino acid substitutions at Screening
- Participant has evidence of current or previous episodes of hepatic decompensation (including controlled or uncontrolled ascites, bleeding varices or hepatic encephalopathy)
- Participant has chronic liver disease of a non-HCV etiology (including but not limited to hemochromatosis, Wilson?s disease, alfa 1-antitrypsin deficiency, cholangitis, drug- or alcohol-related liver disease, primary biliary cirrhosis)
- Participant has any other uncontrolled clinically significant disease or clinically significant findings during Screening that in the opinion of the investigator could compromise the Participants' safety or could interfere with the Participant participating in and completing the study
- Participant has co-infection with human immunodeficiency virus (HIV) type 1 or 2 (positive HIV-1 or HIV-2 antibody test at Screening)
- Participant has received a solid organ transplant

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of a 12-week treatment regimen of simeprevir in combination with daclatasvir, as measured by SVR12, in treatment-naïve, chronic HCV genotype 1b-infected subjects who have advanced fibrosis or compensated cirrhosis;Secondary Objective: - To evaluate the efficacy of a 12-week treatment regimen containing simeprevir and daclatasvir with respect to the percentage of subjects achieving SVR4 and SVR24<br>- To evaluate the incidence of on-treatment failure. <br>- To evaluate the incidence of viral relapse.<br>- To determine/characterize emerging NS3/4A and NS5A mutations in subjects not achieving SVR.<br>- To evaluate safety and tolerability of a 12-week treatment regimen containing simeprevir and daclatasvir.;Primary end point(s): Percentage of Participants With Sustained Virologic Response 12 Weeks After end of Study Drug Treatment (SVR12);Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1- Percentage of Participants with SVR 4 Weeks After end of Study Drug Treatment (SVR4) and SVR 24 Weeks After end of Study Drug Treatment (SVR24)<br>2- Percentage of Participants with On-treatment Failure<br>3- Percentage of Participants with viral breakthrough<br>4- Percentage of Participants With Viral Relapse;Timepoint(s) of evaluation of this end point: 1- Week 16 and Week 36<br>2- Week 12<br>3- Week 12<br>4- Week 12

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