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Completed

NCT Number: NCT02773394

Study 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).

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Goiânia, Brazil

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of participants with chronic hepatitis C infection

    Time frame: Day 1

    Data will be collected through medical records of the participants.

  2. Date of last visit

    Time frame: Day 1

  3. 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.

  4. 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.

  5. Mean Age of Participants with chronic hepatitis C infection

    Time frame: Day 1

    Data will be collected through medical records of the participants.

  6. Number of Males and Females with chronic hepatitis C infection

    Time frame: Day 1

    Data will be collected through medical records of the participants.

  7. 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.

  8. 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.

  9. Duration of diagnosis of chronic hepatitis C infection

    Time frame: Day 1

    Data will be collected through medical records of the participants.

  10. HCV genotype and subtype

    Time frame: Day 1

    Data will be collected through medical records of the participants.

  11. 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).

  12. 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.

  13. 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).

  14. Liver characteristics: Number of Participants with Fibrosis based on Fibroscan

    Time frame: Day 1

    Data will be collected through medical records of the participants.

  15. Number of Participants with Coinfections

    Time frame: Day 1

    Data will be collected through medical records of the participants.

  16. 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.

  17. 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.

  18. 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.

  19. Treatment regimen

    Time frame: Day 1

    The drugs used and time of treatment will be collected through medical records of the participants.

  20. Number of participants with Adverse Events (AEs)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Janssen-Cilag Ltd.

Industry

Registry information

Official study title

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

Acronym: PICTURE

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 16, 2016
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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