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

May 5, 2017 updated by: Janssen-Cilag Ltd.

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

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).

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

1649

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Goiânia, Brazil
      • Porto Alegre, Brazil
      • Porto Velho, Brazil
      • Recife, Brazil
      • Rio Branco, Brazil
      • Rio De Janeiro, Brazil
      • Salvador, Brazil
      • Sao Paulo, Brazil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Analysis set will consist of 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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with chronic hepatitis C infection
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Date of last visit
Time Frame: Day 1
Day 1
Number of Participants with chronic hepatitis C infection Reported Based on City and States
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Number of Participants with chronic hepatitis C infection Based on precedence
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Mean Age of Participants with chronic hepatitis C infection
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Number of Males and Females with chronic hepatitis C infection
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Number of participants with chronic hepatitis C infection Reported Based on Race
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Mode of Hepatitis C virus (HCV) transmission
Time Frame: Day 1
Data will be collected through medical records of the participants. Mode of HCV transmission route (unsafe injections, hemodialysis, infection drug use, blood transfusion, sexual transmission, vertical transmission, unknown, other) will be analysed by number of participants infected with HCV per transmission route.
Day 1
Duration of diagnosis of chronic hepatitis C infection
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
HCV genotype and subtype
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Liver characteristics: Number of Participants with extra hepatic manifestations
Time Frame: Day 1
Data will be collected through medical records of the participants. Presence or absence of extra hepatic manifestations (cryoglobulinemia, lymphoma, Sjogren syndrome, glomerulopathy, Porphyria cutanea tarda, liquen planus, diabetes mellitus, thyroiditis, arthralgia).
Day 1
Liver characteristics: Number of Participants with presence of comorbidities
Time Frame: Day 1
Data will be collected through medical records of the participants. Presence of comorbidities (amount of alcohol ingestion, metabolic syndrome, hepatocellular carcinoma, organ transplantation, diabetes, immunodeficiency, renal insufficiency and dialysis, use of drugs) will be collected.
Day 1
Liver characteristics: Model for End-Stage Liver Disease (MELD) Score and Child Pugh score
Time Frame: Day 1
MELD is a scoring system for assessing the severity of chronic liver disease. Child-Pugh classification assesses the prognosis of chronic liver disease by 5 clinical measures, scored 1-3 each (most severe derangement=3). Score range: 5 (best prognosis) to 15 (worst prognosis).
Day 1
Liver characteristics: Number of Participants with Fibrosis based on Fibroscan
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Number of Participants with Coinfections
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
HCV treatment status on Day 1: Causes of interruption in treatment
Time Frame: Day 1
Data will be collected through medical records of the participants. Causes of interruption to antiviral therapy will be collected and reported.
Day 1
HCV treatment status on Day 1: Number of participants treated without Sustained Virological Response (SVR)
Time Frame: Day 1
Data will be collected through medical records of the participants.
Day 1
Treatment regimen
Time Frame: Day 1
The drugs used and time of treatment will be collected through medical records of the participants.
Day 1
Number of participants with Adverse Events (AEs)
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen-Cilag Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 12, 2016

Primary Completion (Actual)

November 30, 2016

Study Completion (Actual)

November 30, 2016

Study Registration Dates

First Submitted

April 14, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 8, 2017

Last Update Submitted That Met QC Criteria

May 5, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR107066
  • TMC435HPC4013 (Other Identifier: Janssen-Cilag Ltd.)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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