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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effects of Genotypes on Interferon Signaling in Chronic Hepatitis C

NCT00876174

Chronic Hepatitis C

WITHDRAWN

Study to Describe the Actual Situation of Hepatitis C Treatment in Brazil

NCT02773394

Hepatitis C Virus

COMPLETED

Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1

NCT02629172

Chronic Hepatitis C Virus

COMPLETED

Pharmacogenomic Research in Korean Patients With Hepatitis C

NCT01453244

Chronic Hepatitis C

COMPLETED

HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China

NCT01293279

Hepatitis C

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatitis C Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No