Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Treatment chronic hepatitis c
Phase phase 4
Sponsor Seoul National University Boramae Hospital
Collaborator Roche Pharma AG
Start date July 2012
End date June 2017
Trial size 55 participants
Trial identifier NCT01634919, 06-2012-74

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Chronic hepatitis C
chronic hepatitis c noninvasive fibrosis imaging
acoustic radiation force impulse ultrasonography

Primary Outcomes

Measure
Anti-fibrotic response
time frame: 48 weeks after the end of treatment

Secondary Outcomes

Measure
Histologic and noninvasive fibrosis assessments
time frame: 48 weeks after the end of treatment

Eligibility Criteria

Male or female participants at least 20 years old.

Inclusion Criteria: - Male and female subjects ≥20 years of age - Subjects with positive anti-HCV Ab in sera - Subjects with detectable HCV RNA by quantitative real time polymerase chain reaction (PCR) (> 50 IU/mL) - Subjects without receiving any previous antiviral treatment - Subjects undergoing radiologic studies (liver ultrasonography (USG), CT or MRI) to exclude the presence of hepatocellular carcinoma (HCC) within the last 1 year before enrolment - All fertile males with partners of childbearing age and females must be using reliable contraception during the study and for 3 months after treatment completion - Written informed consent should be obtained from all subjects. Exclusion Criteria: - History of any interferon (IFN)-based therapy before enrolment - Positive test at screening for anti-hepatitis A virus (HAV) immunoglobulin M (IgM) Ab, HBsAg, anti-hepatitis D virus (HDV) Ab or anti- HIV Ab - Histologically confirmed liver cirrhosis (F4 of fibrosis stage) - If subjects have compromised liver function (Child-Pugh score >6) - Signs or symptoms of hepatocellular carcinoma within the last 1 year before enrolment - History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures, thalassemia) - Women with ongoing pregnancy or who are breast feeding - Male partner of potentially pregnant women - Neutrophil count <1,500 cells/mm3 or platelet count <75,000 cells/mm3 at screening - Hemoglobin <11 g/dL for females and <12 g/dL for men at screening - Serum creatinine level >1.5 times the upper limit of normal at screening - Evidence of immunosuppressive therapy - History of severe psychiatric disease, especially depression.(Severe psychiatric disease is defined as major depression or psychosis, suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease)

Additional Information

Official title 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
Principal investigator Won Kim, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Seoul National University Boramae Hospital.