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

Hepatitis C Virus Clinical Trial

— PICTURE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02773394
• Other study ID #: CR107066
• Secondary ID: TMC435HPC4013
• Status: Completed
• Phase: N/A
• First received: April 14, 2016
• Last updated: May 5, 2017
• Start date: April 12, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: May 2017
• Source: Janssen-Cilag Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 naive, in treatment and previously exposed to antiviral treatment without sustained virological response (SVR).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1649
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag Ltd.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with chronic hepatitis C infection	Data will be collected through medical records of the participants.	Day 1
Primary	Date of last visit		Day 1
Primary	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
Primary	Number of Participants with chronic hepatitis C infection Based on precedence	Data will be collected through medical records of the participants.	Day 1
Primary	Mean Age of Participants with chronic hepatitis C infection	Data will be collected through medical records of the participants.	Day 1
Primary	Number of Males and Females with chronic hepatitis C infection	Data will be collected through medical records of the participants.	Day 1
Primary	Number of participants with chronic hepatitis C infection Reported Based on Race	Data will be collected through medical records of the participants.	Day 1
Primary	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
Primary	Duration of diagnosis of chronic hepatitis C infection	Data will be collected through medical records of the participants.	Day 1
Primary	HCV genotype and subtype	Data will be collected through medical records of the participants.	Day 1
Primary	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
Primary	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
Primary	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
Primary	Liver characteristics: Number of Participants with Fibrosis based on Fibroscan	Data will be collected through medical records of the participants.	Day 1
Primary	Number of Participants with Coinfections	Data will be collected through medical records of the participants.	Day 1
Primary	HCV treatment status on Day 1: Percentage of participants receiving antiviral treatment	Data will be collected through medical records of the participants.	Day 1
Primary	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
Primary	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
Primary	Treatment regimen	The drugs used and time of treatment will be collected through medical records of the participants.	Day 1
Primary	Number of participants with Adverse Events (AEs)		Day 1