Hepatitis C VirusPICTURENCT02773394
Study to Describe the Actual Situation of Hepatitis C Treatment in Brazil
An observational study of Hepatitis C Virus, run by Janssen-Cilag Ltd. at 8 sites in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C Virus
- How many people
- 1,649 participants
- Where
- 8 sitesBrazil
- Study dates
- 12 Apr 2016to 30 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 1 country.
8 sites in 1 country
Brazil8 sites
Study site
Goiânia
Study site
Porto Alegre
Study site
Porto Velho
Study site
Recife
Study site
Rio Branco
Study site
Rio de Janeiro
Study site
Salvador
Study site
São Paulo
About this study
Official title: 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).
Read the 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
- Keywords
- Hepatitis C Virus, Observational, Brazil
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Measured: Day 1
Date of last visit
Measured: 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.
Measured: Day 1
Number of Participants with chronic hepatitis C infection Based on precedence
Data will be collected through medical records of the participants.
Measured: Day 1
Mean Age of Participants with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Measured: Day 1
Number of Males and Females with chronic hepatitis C infection
Data will be collected through medical records of the participants.
Measured: Day 1
Number of participants with chronic hepatitis C infection Reported Based on Race
Data will be collected through medical records of the participants.
Measured: 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.
Measured: Day 1
Duration of diagnosis of chronic hepatitis C infection
Data will be collected through medical records of the participants.
Measured: Day 1
HCV genotype and subtype
Data will be collected through medical records of the participants.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Day 1
Liver characteristics: Number of Participants with Fibrosis based on Fibroscan
Data will be collected through medical records of the participants.
Measured: Day 1
Number of Participants with Coinfections
Data will be collected through medical records of the participants.
Measured: Day 1
HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment
Data will be collected through medical records of the participants.
Measured: 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.
Measured: 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.
Measured: Day 1
Treatment regimen
The drugs used and time of treatment will be collected through medical records of the participants.
Measured: Day 1
Number of participants with Adverse Events (AEs)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2016 (estimated)
- Study start12 Apr 2016
- Primary completion30 Nov 2016
- Study completion30 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,649 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Ltd. Clinical Trial, Study director, Janssen-Cilag Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02773394
- Sponsor's protocol ID
- CR107066
- Other IDs
- TMC435HPC4013
- Acronym
- PICTURE
- Status last verified
- Jan 2025
- First submitted
- 14 Apr 2016
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protocol to Describe the Actual Situation of Hepatitis C Treatment in Brazil
- ClinicalTrials.gov ID
- NCT02773394
- Acronym / sponsor ID
- PICTURE / CR107066
- Conditions
- Hepatitis C Virus
- Keywords
- Hepatitis C Virus, Observational, Brazil
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,649 participants (actual)
- Lead sponsor
- Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Apr 2016 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 30 Nov 2016 (actual)
- First posted
- 16 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with chronic hepatitis C infection
Time frame: Day 1
Data will be collected through medical records of the participants.
Date of last visit
Time frame: 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.
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.
Mean Age of Participants with chronic hepatitis C infection
Time frame: Day 1
Data will be collected through medical records of the participants.
Number of Males and Females with chronic hepatitis C infection
Time frame: Day 1
Data will be collected through medical records of the participants.
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.
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.
Duration of diagnosis of chronic hepatitis C infection
Time frame: Day 1
Data will be collected through medical records of the participants.
HCV genotype and subtype
Time frame: Day 1
Data will be collected through medical records of the participants.
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).
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.
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).
Liver characteristics: Number of Participants with Fibrosis based on Fibroscan
Time frame: Day 1
Data will be collected through medical records of the participants.
Number of Participants with Coinfections
Time frame: Day 1
Data will be collected through medical records of the participants.
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.
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.
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.
Treatment regimen
Time frame: Day 1
The drugs used and time of treatment will be collected through medical records of the participants.
Number of participants with Adverse Events (AEs)
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag Ltd. Clinical Trial study director
Janssen-Cilag Ltd.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Virus, run by Janssen-Cilag Ltd. at 8 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with chronic hepatitis C infection (time frame: Day 1). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.