Clinical trial NCT02773394: Study to Describe the Actual Situation of Hepatitis C Treatment in Brazil
Official title: Protocol to Describe the Actual Situation of Hepatitis C Treatment in Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C Virus
Keywords: Hepatitis C Virus
Observational
Brazil
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-16
Enrollment: 1649
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants with chronic hepatitis C infection
timeFrame: Day 1
measure: Date of last visit
timeFrame: Day 1
measure: Number of Participants with chronic hepatitis C infection Reported Based on City and States
timeFrame: Day 1
measure: Number of Participants with chronic hepatitis C infection Based on precedence
timeFrame: Day 1
measure: Mean Age of Participants with chronic hepatitis C infection
timeFrame: Day 1
measure: Number of Males and Females with chronic hepatitis C infection
timeFrame: Day 1
measure: Number of participants with chronic hepatitis C infection Reported Based on Race
timeFrame: Day 1
measure: Mode of Hepatitis C virus (HCV) transmission
timeFrame: Day 1
measure: Duration of diagnosis of chronic hepatitis C infection
timeFrame: Day 1
measure: HCV genotype and subtype
timeFrame: Day 1
measure: Liver characteristics: Number of Participants with extra hepatic manifestations
timeFrame: Day 1
measure: Liver characteristics: Number of Participants with presence of comorbidities
timeFrame: Day 1
measure: Liver characteristics: Model for End-Stage Liver Disease (MELD) Score and Child Pugh score
timeFrame: Day 1
measure: Liver characteristics: Number of Participants with Fibrosis based on Fibroscan
timeFrame: Day 1
measure: Number of Participants with Coinfections
timeFrame: Day 1
measure: HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment
timeFrame: Day 1
measure: HCV treatment status on Day 1: Causes of interruption in treatment
timeFrame: Day 1
measure: HCV treatment status on Day 1: Number of participants treated without Sustained Virological Response (SVR)
timeFrame: Day 1
measure: Treatment regimen
timeFrame: Day 1
measure: Number of participants with Adverse Events (AEs)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Goiania
country: Brazil
city: Porto Alegre
country: Brazil
city: Porto Velho
country: Brazil
city: Recife
country: Brazil
city: Rio Branco
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical Trial
role: STUDY_DIRECTOR
References: