NCT01378104

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 178 (actual)
• Sponsor: The Catholic University of Korea · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

Conditions

• Sustained Virologic Response
• IL28B Polymorphism

Interventions

Type	Name	Description
DRUG	peginterferon alfa 2a (pegasys)	dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
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.

Timeline

• Start date: 2008-10-01
• Primary completion: 2011-09-01
• Completion: 2012-09-01
• First posted: 2011-06-22
• Last updated: 2013-03-08
• Results posted: 2013-03-08

Locations

14 sites across 1 country: South Korea