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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Belém, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Number of Participants With HCV NS3/4a Protease and NS5A Protein

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.

Industry

Registry information

Official study title

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

Acronym: MAPPING

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Nov 5, 2015
Registry last updated: Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed