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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Hepatitis C Virus

Study type: Observational

Funder types: Industry

Identifiers

NCT02773394

TMC435HPC4013 (Other Identifier)

CR107066

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 1,649 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

1,649 participants in 1 patient group

Group 1

Description:

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.