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

November 28, 2024 updated by: Won Kim, Seoul National University Boramae Hospital

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

•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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 156-707
        • SMG-SNU Boramae Medical Center
      • Seoul, Korea, Republic of, 156-707
        • Seoul Metropolitan Government Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Hospital-based cohort

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Chronic hepatitis C
Device: chronic hepatitis C
acoustic radiation force impulse ultrasonography
Other Names:
  • noninvasive fibrosis imaging

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Anti-fibrotic response
Time Frame: 48 weeks after the end of treatment
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Histologic and noninvasive fibrosis assessments
Time Frame: 48 weeks after the end of treatment
  • Liver fibrosis score(according to the viral genotype or virologic response)
  • Morphometric analysis of fibrosis surface area
  • Acoustic radiation force impulse (ARFI) ultrasound imaging and clinical fibrosis indices (APRI, FIB-4, FibroTest®, and ELF test)
  • Noninvasive tests using the tissue shear wave speed and clinical fibrosis indices
48 weeks after the end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Boramae Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Pharma AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Won Kim, Ph.D, SMG-SNU Boramae Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 9, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 3, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 3, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 28, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 06-2012-74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings