An Observational/Non-interventional, Study of NS3/4a Protease and NS5A Protein of Hepatitis C Virus in Brazilian Participants With Chronic HCV Infection

Completed

• Conditions: Hepatitis C Virus

• Registration Number: NCT02597270
• Lead Sponsor: Janssen-Cilag Ltd.

Brief Summary

The purpose of this study is to describe the genetic diversity of Hepatitis C virus (HCV) NS3/4a protease and NS5A protein of HCV in participants with chronic disease naive-drug or previously failed to double therapy (Peg-interferon and Ribavirin) and to identify the frequency of natural polymorphisms in HCV NS3/4a protease and NS5A protein that are associated with direct-acting antivirals (DAAs)-resistance.

Detailed Description

This is a multicenter, observational/non-interventional, cross-sectional study to describe the genetic diversity of and to identify the natural polymorphisms in HCV NS3/4a protease and NS5A protein of hepatitis C virus in Brazilian participants with chronic HCV infection. Brazilian participants with Genotype 1 HCV infection treatment naive participants or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial and will constitute the trial population.

Study Timeline

• Study First Submitted: 2015-11-03
• Study First Submitted QC: 2015-11-03
• Study First Posted: 2015-11-05
• Study Start: 2016-03
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-03
• Last Update Posted: 2017-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

Inclusion Criteria

• Participants mono infected with chronic Hepatitis C infection (genotype 1), including naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin)
• There is no restriction on fibrosis stage or clinical liver disease
• There is no restriction for comorbidities
• Male or female participants with age >=18 years

Exclusion Criteria

• Participants failed to triple therapy using protease inhibitors
• Participants with co-infections (i.e. Human immunodeficiency virus, Hepatitis B virus)
• Participants that are not agree to sign the written informed consent
• Participants is taking part in an interventional clinical trial with an investigational agent (i.e. non-commercialized agent) or in an interventional clinical trial sponsored by Johnson & Johnson

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants With HCV NS3/4a Protease and NS5A Protein	Day 1	After extraction of HCV RNA from collected blood samples, the sequences of the NS3/4A and NS5A genes of HCV will be amplified by reverse transcription polymerase chain reaction (RTPCR) using specific primers for each genomic region. PCR products will be sequenced subsequently by direct sequencing. Detection of natural polymorphisms will be analyzed a comparison of the each sequence with the subtype consensus sequence.