Clinical trial NCT01671046: An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-23
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis C

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start
timeFrame: 24 months
measure: Correlation of liver elasticity evolution with viral kinetics
timeFrame: 24 months
Secondary outcomes:
measure: Safety: incidence of adverse events
timeFrame: 24 months
measure: Correlation of liver fibrosis stages with sustained virological response (SVR)
timeFrame: 24 months
measure: Correlation of patients characteristics with sustained virological response
timeFrame: 24 months
measure: Hepatic transient elastography (M-transducer)
timeFrame: 24 months
measure: Hepatic transient elastography (XL-transducer)
timeFrame: 24 months
measure: Correlation of hepatic steatosis score with sustained virological response
timeFrame: 24 months
measure: Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy
timeFrame: 24 months
measure: Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients
timeFrame: 24 months
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Botucatu
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Santo Andre
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: