Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C

May 12, 2012 updated by: Young-Suk Lim, Asan Medical Center

Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C

The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008

Study Type

Interventional

Enrollment (Actual)

272

Phase

  • Phase 4

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

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: all of below

  • adults aged 18-70 years
  • serum anti-HCV antibody (+)
  • HCV RNA detectable by PCR
  • compensated liver disease (Child-Pugh class A)

Exclusion Criteria: any of below

  • HCV genotype other than 1, 2, or 3
  • acute hepatitis C
  • decompensated cirrhosis or hepatocellular carcinoma
  • other liver disease such as hepatitis A or B, or autoimmune hepatitis
  • HIV Ab(+)
  • severe depression or other psychiatric disease
  • previous organ transplantation
  • absolute neutrophil count (ANC) < 1,000 cells/mm3 or platelet count < 75,000 cells/mm3, or hemoglobin (Hb) < 13 g/dL for men, <12 g/dL for women

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Korean CHC
Two CHC patient groups. One is CHC patients who are treated with combination of peginterferon alfa-2a and ribavirin in a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004. Another is a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008.
Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1
Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks.
Other Names:
  • Pegasys
  • Copegus
Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.
Other Names:
  • Pegasys
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients achieving sustained virological response (SVR)
Time Frame: at 24 weeks after cessation of treatment
SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment
at 24 weeks after cessation of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of patients achieving early virological response (EVR)
Time Frame: at 12 weeks of treatment
EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment
at 12 weeks of treatment
the proportion of patients achieving complete EVR (cEVR)
Time Frame: at 12 weeks of treatment
cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment
at 12 weeks of treatment
The proportion of patients achieving end-of-treatment response (ETR)
Time Frame: at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3
ETR is defined as HCV RNA undetectable at the end of treatment.
at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3

Collaborators and Investigators

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

Sponsor

Asan Medical Center

Collaborators

Samsung Medical Center
Seoul St. Mary's Hospital
Korea University Guro Hospital
Gangnam Severance Hospital
Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2003

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

May 7, 2012

First Submitted That Met QC Criteria

May 9, 2012

First Posted (Estimate)

May 11, 2012

Study Record Updates

Last Update Posted (Estimate)

May 15, 2012

Last Update Submitted That Met QC Criteria

May 12, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMC2003-0059

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.

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