NCT01056172

PegIFN Alfa-2a and RBV for 16 or 24 Weeks in Patients With Chronic Hepatitis C(CHC) 2 With Rapid Virologic Response(RVR)

A Prospective Randomized, Open Labeled, Phase IV, Multicenter Study for Peginterferon Alfa-2a and Weight-based Ribavirin for 16 or 24 Weeks in genotype2 Chronic Hepatitis C Patients Who Achieved Rapid Virologic Response

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 164 (estimated)
• Sponsor: Pusan National University Yangsan Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aim to evaluate the non-inferiority of sustained virologic response in peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Detailed description

In recent study (the ACCELERATE trial), treatment with peginterferon alfa-2a and ribavirin (800mg/day) for 16 weeks in patients infected with HCV genotype 2 or 3 result in a lower overall sustained virologic response rate than treatment with the standard 24 weeks regimen. Ribavirin was used as a flat dose (800mg/day) in ACCELERATE trial. But, previous studies which used the weight-based dose of ribavirin (800-1400mg/day) had shown that a treatment duration of 16 weeks was as effective as 24 weeks regimen in HCV genotype 2 patients with a RVR. But, there was too small number of patient enrolled study to argue logically about ACCELERATE trial. In this study, we aimed to confirm the non-inferiority peginterferon alfa-2a and weight-based ribavirin for 16 weeks compare with standard treatment duration of 24 weeks in patients who achieved rapid virologic response with genotype 2 CHC.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a and Ribavirin	1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day) 3. Treatment duration: 16 weeks
DRUG	Peginterferon alfa-2a and Ribavirin	1. PegIFN alfa-2a (PEgasys) 180 ug/week 2. Weight-based ribavirin (\<65kg: 800mg/day, 65-85kg: 1000mg/day, \>85kg: 1200mg/day) 3. Treatment duration: 24 weeks

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-06-01
• Completion: 2012-12-01
• First posted: 2010-01-26
• Last updated: 2012-04-20

Locations

8 sites across 1 country: South Korea