NCT02597270

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

Mapping Natural Polymorphisms of Hepatitis C Virus NS3/4A Protease and NS5A Region Among Brazilian Chronic Patients (MAPPING)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 239 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2015-11-05
• Last updated: 2017-02-06

Locations

6 sites across 1 country: Brazil