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

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

Detailed Description
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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

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

Conditions
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Sustained Virologic Response, IL28B Polymorphism

Intervention / Treatment
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* Drug: peginterferon alfa 2a (pegasys)
* Drug: peginterferon alfa-2a (pegasys)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 80% dosage group of peginterferon alfa 2a<br>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)<br>* dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable<br>* Other names: Roche;|
| Active Comparator: 100% dosage group of peginterferon alfa 2a<br>These group patients would be treated with standard dose 180 ug/week for 48 weeks. | Drug: peginterferon alfa-2a (pegasys)<br>* 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.<br>* Other names: Roche;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | post treatment 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | post treatment 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reducing dose of peginterferon, chronic hepatitis c, Koreans, IL28B polymorphism