Histologic Changes and Noninvasive Assessment in Hepatitis C Patients Treated with Peginterferon … (NCT01634919) | Clinical Trial Compass
CompletedNot Applicable
Histologic Changes and Noninvasive Assessment in Hepatitis C Patients Treated with Peginterferon Alpha-2a and Ribavirin
South Korea55 participantsStarted 2012-07
Plain-language 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
Who can participate
Age range20 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 c…