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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Hepatitis C Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT02597270

TMC435HPC4012 (Other Identifier)

CR107065

Details and patient eligibility

About

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.

Full 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.

Enrollment: 239 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

239 participants in 1 patient group

Cohort 1

Description:

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.