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Completed

NCT Number: NCT01378104

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soonchunghyang University Hospital, Bucheon-si, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

peginterferon alfa 2a (pegasys)

Drug

dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable

Other names: Roche

peginterferon alfa-2a (pegasys)

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2012
First posted
Jun 22, 2011
Registry last updated
Mar 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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