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

NCT01634919 | Completed

• 1 other identifier: 06-2012-74
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis C; Liver fibrosis; ARFI(Acoustic radiation force impulse)

Outcome Measures

Primary Outcomes (1)

• Anti-fibrotic response

  Anti-fibrotic response, indicated by a lack of histological worsening, defined as the stabilization or the improvement of at least one stage in the histologic fibrosis staging 48 weeks after the end of treatment

  48 weeks after the end of treatment

Secondary Outcomes (1)

• Histologic and noninvasive fibrosis assessments

  48 weeks after the end of treatment

Study Arms (1)

Chronic hepatitis C

Chronic hepatitis C

Device: chronic hepatitis C

Interventions

chronic hepatitis C DEVICE

acoustic radiation force impulse ultrasonography

Also known as: noninvasive fibrosis imaging

Chronic hepatitis C

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospital-based cohort

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Seoul National University Boramae Hospital: lead

Study Sites (2)

Seoul Metropolitan Government Boramae Medical Center

Seoul, 156-707, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, 156-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Liver tissue in frozen states * Whole blood including PBMC and sera

MeSH Terms

Conditions

Hepatitis C, Chronic; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fibrosis

Study Officials

• Won Kim, Ph.D

  SMG-SNU Boramae Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Professor

Study Record Dates

• First Submitted: July 3, 2012
• First Posted: July 6, 2012
• Study Start: July 1, 2012
• Primary Completion: February 17, 2017
• Study Completion: February 9, 2018
• Last Updated: December 3, 2024

Record last verified: 2024-11

Locations

KR (2)