Clinical trial NCT02597270: An Observational/Non-interventional, Study of NS3/4a Protease and NS5A Protein of Hepatitis C Virus in Brazilian Participants With Chronic HCV Infection
Official title: Mapping Natural Polymorphisms of Hepatitis C Virus NS3/4A Protease and NS5A Region Among Brazilian Chronic Patients (MAPPING)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Keywords: Hepatitis C virus
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Brazilian participants with Genotype 1 HCV infection treatment naive patients or previously failed to double therapy (Peg-interferon-α and Ribavirin) will be included in the trial.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With HCV NS3/4a Protease and NS5A Protein
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Belém
country: Brazil
city: Goiânia
country: Brazil
city: Porto Alegre
country: Brazil
city: Porto Velho
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: