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

The Catholic University of Korea

Status and phase: Completed; Phase 4

Conditions: Sustained Virologic Response; IL28B Polymorphism

Treatments: Drug: peginterferon alfa 2a (pegasys); Drug: peginterferon alfa-2a (pegasys)

Study type: Interventional

Funder types: Other

Identifiers

NCT01378104

PEGASYS100:80

Details and patient eligibility

About

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

Full 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

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 2 patient groups

80% dosage group of peginterferon alfa 2a

Experimental group

Description:

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.

Treatment:

Drug: peginterferon alfa 2a (pegasys)

100% dosage group of peginterferon alfa 2a

Active Comparator group

Description:

These group patients would be treated with standard dose 180 ug/week for 48 weeks.

Treatment:

Drug: peginterferon alfa-2a (pegasys)