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

The Catholic University of Korea178 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Sustained Virologic Response IL28B Polymorphism

Interventions

peginterferon alfa 2a (pegasys)DRUG

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

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (14)

Soonchunghyang University Hospital

Bucheon-si, South Korea

Hallym University Chunchun Medical center

Chunchun, South Korea

Keimyung University hospital

Daegu, South Korea

Outcomes

Primary Outcomes

Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a

We investigate whether the SVR between 100% and 80% group of peginterferon alfa 2a is not different.

Time frame: post treatment 24 weeks

Secondary Outcomes

IL28B Polymorphism Effect on SVR

We additionally investigate the IL28B polymorphism and this result can effect on the SVR depending on dosage of peginterferon alfa-2a.

Time frame: post treatment 24 weeks

Data from ClinicalTrials.gov

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