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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01671046
• Other study ID #: ML27944
• Status: Completed
• Phase: N/A
• First received: August 20, 2012
• Last updated: November 1, 2016
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: ANVISA (Agência Nacional de Vigilância Sanitária)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Liver Cirrhosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start		24 months	No
Primary	Correlation of liver elasticity evolution with viral kinetics		24 months	No
Secondary	Safety: incidence of adverse events		24 months	No
Secondary	Correlation of liver fibrosis stages with sustained virological response (SVR)		24 months	No
Secondary	Correlation of patients characteristics with sustained virological response		24 months	No
Secondary	Hepatic transient elastography (M-transducer)		24 months	No
Secondary	Hepatic transient elastography (XL-transducer)		24 months	No
Secondary	Correlation of hepatic steatosis score with sustained virological response		24 months	No
Secondary	Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy		24 months	No
Secondary	Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients		24 months	No