Study to Describe the Actual Situation of Hepatitis C Treatment in Brazil
PICTURE
Protocol to Describe the Actual Situation of Hepatitis C Treatment in Brazil
2 other identifiers
observational
1,649
1 country
8
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 12, 2016
CompletedFirst Submitted
Initial submission to the registry
April 14, 2016
CompletedFirst Posted
Study publicly available on registry
May 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2016
CompletedFebruary 3, 2025
January 1, 2025
8 months
April 14, 2016
January 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (20)
Number of participants with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Day 1
Date of last visit
Day 1
Number of Participants with chronic hepatitis C infection Reported Based on City and States
Data will be collected through medical records of the participants.
Day 1
Number of Participants with chronic hepatitis C infection Based on precedence
Data will be collected through medical records of the participants.
Day 1
Mean Age of Participants with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Day 1
Number of Males and Females with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Day 1
Number of participants with chronic hepatitis C infection Reported Based on Race
Data will be collected through medical records of the participants.
Day 1
Mode of Hepatitis C virus (HCV) transmission
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
Data will be collected through medical records of the participants.
Day 1
HCV genotype and subtype
Data will be collected through medical records of the participants.
Day 1
Liver characteristics: Number of Participants with extra hepatic manifestations
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
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
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
Data will be collected through medical records of the participants.
Day 1
Number of Participants with Coinfections
Data will be collected through medical records of the participants.
Day 1
HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment
Data will be collected through medical records of the participants.
Day 1
HCV treatment status on Day 1: Causes of interruption in treatment
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)
Data will be collected through medical records of the participants.
Day 1
Treatment regimen
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)
Day 1
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Unknown Facility
Goiânia, Brazil
Unknown Facility
Porto Alegre, Brazil
Unknown Facility
Porto Velho, Brazil
Unknown Facility
Recife, Brazil
Unknown Facility
Rio Branco, Brazil
Unknown Facility
Rio de Janeiro, Brazil
Unknown Facility
Salvador, Brazil
Unknown Facility
São Paulo, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag Ltd. Clinical Trial
Janssen-Cilag Ltd.
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2016
First Posted
May 16, 2016
Study Start
April 12, 2016
Primary Completion
November 30, 2016
Study Completion
November 30, 2016
Last Updated
February 3, 2025
Record last verified: 2025-01