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

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

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Recruitment Status

COMPLETED

Total Enrollment

1649 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-12

Study Completion Date

2016-11-30

Brief Summary

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The purpose of the study is to describe: 1) the clinical profile, past and current management of participants with hepatitis C in Brazil reference centers; 2) the current situation about demographics characteristics, liver disease progression and clinical outcomes in Brazilian Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral treatment without sustained virological response (SVR).

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Detailed Description

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This is an observational, non-interventional, cross-sectional, multicenter study to describe demographic characteristics, treatment performed and clinical outcomes of Brazilian participants with HCV chronic infection in about 12 Brazilian reference centers. It will expect that approximately 2000 participants will be enrolled in the study. Analysis set will consist of participants with HCV chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype. The study related data will be collected from the medical records in the predesigned electronic Case Report Form (eCRF).

Conditions

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Hepatitis C Virus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group 1

Brazilian participants with Hepatitis C virus (HCV) chronic infection who are registered at the Brazilian reference centers and meet all the inclusion criteria and have sufficient information to identify the diagnosis of chronic HCV infection with identification of genotype.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Participants with diagnosis confirmed with Hepatitis C infection being followed into the reference centers
* There is no restriction on fibrosis stage or clinical liver disease
* There is no restriction for comorbities or coinfections
* Diagnosis of chronic HCV infection detected by anti-HCV (ELISA assays), HCV Ribonucleic acid (RNA) (polymerase chain reaction \[PCR\] reaction) with identification of genotype

Exclusion Criteria

* Male or female participant with age greater than or equal to 18 years
* participating in another interventional clinical trial
* Treated participants who achieved sustained Virological Response (SVR)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No