100% VS 80% Of Pegasys In Koreans With Chronic Hepatitis C (CHC)

February 3, 2013 updated by: Jung Hyun Kwon, The Catholic University of Korea

The Response of Reducing Dose of Peginterferon Alfa-2a in Koreans With Chronic Hepatitis C Genotype 1; Randomized Controlled Multicenter Study 100% Versus 80%

  1. Randomized controlled multicenter study
  2. The response of reducing dose of peginterferon alfa-2a in Koreans with chronic hepatitis C genotype 1
  3. IL28B polymorphism in Koreans with CHC

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The virologic response of Koreans to combination therapy for chronic hepatitis C is similar to non-Asians; however, dose modification occurs more frequently in Koreans.

-When we evaluated the rates of peginterferon α-2a and ribavirin dose modifications and their effect on the virologic response in Koreans, we suggested that using at least 80% of the peginterferon α-2a dose in Koreans not only maintains SVR but also reduces drug side effects during the entire treatment period and a lower dose of ribavirin may be as efficacious as a standard dose(Korean J Intern Med 2009;24:203-211).

So we investigate whether the group of 80% use dosage of peginterferon alfa-2a did not show inferior response rather than that of 100 % use dosage group and minimize the adverse events.

There are recently reports that Koreans have favorable IL28B SNP for CHC treatment.

-We investigate the IL28B polymorphism in Koreans with CHC and this result can effect on the SVR depending on the dosage of peginterferon alfa 2a

Study Type

Interventional

Enrollment (Actual)

178

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

  • Korea, Republic of
      • Bucheon, Korea, Republic of
        • Soonchunghyang University Hospital
      • Chunchun, Korea, Republic of
        • Hallym University Chunchun Medical center
      • Daegu, Korea, Republic of
        • Kyungpook National University Hospital
      • Daegu, Korea, Republic of
        • Keimyung University Hospital
      • Daejun, Korea, Republic of
        • Ghungnam National University hospital
      • Daejun, Korea, Republic of
        • Konyang University Hospital
      • Incheon, Korea, Republic of
        • Inha University Hospital
      • Incheon, Korea, Republic of
        • Incheon St. Mary's Hospital
      • Koyang-si, Korea, Republic of
        • Inje University, Ilsan Paik Hospital
      • Koyang-si, Korea, Republic of
        • NHIC Ilsan Hospital
      • Pusan, Korea, Republic of
        • Inje University, Pusan Paik Hospital
      • Seoul, Korea, Republic of
        • Seoul St. Mary's Hospital, The Catholic University of Korea
      • Ulsan, Korea, Republic of
        • Ulsan University
      • Wonju-si, Korea, Republic of
        • Yonsei University, Wonju Hospital

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic hepatitis C (anti HCV+, HCV RNA +)
  • Genotype 1
  • over 18 year-old
  • Pregnancy test negative if women of childbearing age

Exclusion Criteria:

  • pregnant women or breast feeding women
  • systemic chemotherapy or steroid therapy before 6 months of trial
  • Coinfection with HAV, HBV, and HIV
  • Other liver disease such as hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxic hepatitis
  • Hepatocellular carcinoma
  • Evidence of decompensation such as variceal bleeding,ascites, encephalopathy
  • ANC less than 1500, platelet less than 90k
  • Cr more than 1.5 of UNL
  • Severe psychiatric problem
  • Poorly controlled thyroid disease
  • Severe retinopathy

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 80% dosage group of peginterferon alfa 2a
This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.
Drug: peginterferon alfa 2a (pegasys)
dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
Other Names:
  • Roche
Active Comparator: 100% dosage group of peginterferon alfa 2a
These group patients would be treated with standard dose 180 ug/week for 48 weeks.
Drug: peginterferon alfa-2a (pegasys)
These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
Other Names:
  • Roche

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a
Time Frame: post treatment 24 weeks
We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.
post treatment 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IL28B Polymorphism Effect on SVR
Time Frame: post treatment 24 weeks
We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.
post treatment 24 weeks

Collaborators and Investigators

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

Sponsor

The Catholic University of Korea

Collaborators

Ulsan University Hospital
Yonsei University
Kyungpook National University Hospital
Inje University
Soonchunhyang University Hospital
Hallym University Medical Center
Inha University Hospital
Chungnam National University
National Health Insurance Service Ilsan Hospital
Keimyung University
Konyang University Hospital

Investigators

  • Principal Investigator: Jung Hyun Kwon, MD, Assistant professor, The Catholic University of Korea

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

October 1, 2008

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 20, 2011

First Posted (Estimate)

June 22, 2011

Study Record Updates

Last Update Posted (Estimate)

March 8, 2013

Last Update Submitted That Met QC Criteria

February 3, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEGASYS100:80

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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