An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection

Prospective Multicenter Observational Trial to Evaluate Correlation Between Liver Biopsy and Transient Elastography in Liver Fibrosis Assessment and Correlation Between Viral Kinetics and Transient Elastography Evolution During Hepatitis C Treatment in a Population of Chronic HCV Infected Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01671046

Enrollment

123

Registered

2012-08-23

Start date

2012-07-31

Completion date

2015-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic

Brief summary

This multi-center, prospective observational study will evaluate the correlation of liver biopsy and transient elastography in liver fibrosis assessment in patients with chronic hepatitis C. Data will be collected for 96 weeks.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 18 years of age * Chronic Hepatitis C infection (mono-infection or co-infection with human immunodeficiency virus \[HIV\]) * Detectable level of hepatitis C RNA * Initiating treatment with pegylated interferon plus ribavirin, or pegylated interferon plus ribavirin, and boceprevir or telaprevir according to local guidelines * Last liver biopsy performed no later than 3 months prior to enrolment to study

Exclusion criteria

* Co-infection with hepatitis B virus * Previous treatment with pegylated interferon and ribavirin * Participation in another clinical study in the last 12 months prior to study start

Design outcomes

Primary

Measure	Time frame
Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start	24 months
Correlation of liver elasticity evolution with viral kinetics	24 months

Secondary

Measure	Time frame
Correlation of patients characteristics with sustained virological response	24 months
Hepatic transient elastography (M-transducer)	24 months
Hepatic transient elastography (XL-transducer)	24 months
Safety: incidence of adverse events	24 months
Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy	24 months
Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients	24 months
Correlation of hepatic steatosis score with sustained virological response	24 months
Correlation of liver fibrosis stages with sustained virological response (SVR)	24 months

Countries

Brazil

Outcome results