NCT02773394

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,649 (actual)
• Sponsor: Janssen-Cilag Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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).

Conditions

• Hepatitis C Virus

Timeline

• Start date: 2016-04-12
• Primary completion: 2016-11-30
• Completion: 2016-11-30
• First posted: 2016-05-16
• Last updated: 2025-02-03

Locations

8 sites across 1 country: Brazil