NCT01634919

Histologic Changes and Noninvasive Assessment in Hepatitis C Patients Treated with Peginterferon Alpha-2a and Ribavirin

A Single Center, Prospective Study Evaluating the Anti-fibrotic Effect of Combination Therapy of Peginterferon Alpha-2a Plus Ribavirin in Patients with Chronic Hepatitis C, Based on Histologic Changes and Noninvasive Fibrosis Assessments

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Seoul National University Boramae Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

•The purpose of this study is to compare the performance between liver biopsy and non-invasive fibrosis assessments evaluating anti-fibrotic efficacy of peginterferon plus ribavirin in patients with hepatitis C pre- and post-treatment

Detailed description

* Patients with histologically advanced hepatitis C receiving peginterferon plus ribavirin combination therapy have showed 30-40% of a sustained virologic response (SVR) rate and 50% of histologic improvement. * The histologic change of liver is the most important prognosticator to predict further clinical outcomes in advanced hepatitis C patients following peginterferon-based antiviral therapy. * Although liver biopsy remains the gold standard for histologic assessment, it has several shortcomings in terms of poor repeatability due to its invasiveness and poor reproducibility due to sampling error and intra- or inter-observer variability. * Treatment-naïve patients with chronic hepatitis C will receive PEGASYS® 180 mcg once weekly and ribavirin twice daily for 24 or 48 weeks depending on the genotype of hepatitis C virus (HCV). * All subjects will be followed for up to 48 weeks after treatment cessation. * Liver biopsy will be done at baseline and the end of follow-up for the evaluation of histologic response. * Noninvasive tests for liver fibrosis (ARFI elastography, APRI, FIB-4, FibroTest®, and ELF test) will be assessed per 24 weeks during the whole study period. * The results of this study will provide insight into the histo-physical link between histologic changes and liver stiffness dynamics during and after peginterferon alpha-2a plus ribavirin treatment in patients with advanced hepatitis C. * Therefore, noninvasive fibrosis assessments may be useful to trace fibrosis outcomes in patients with advanced hepatitis C receiving antiviral therapy.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DEVICE	chronic hepatitis C	acoustic radiation force impulse ultrasonography

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-02-17
• Completion: 2018-02-09
• First posted: 2012-07-06
• Last updated: 2024-12-03

Locations

2 sites across 1 country: South Korea