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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Catholic University of Korea
• Collaborators: Chungnam National University; Hallym University Medical Center; Inha University Hospital; Inje University; Keimyung University; Konyang University Hospital; Kyungpook National University; Kyungpook National University Hospital; National Health Insurance Service Ilsan Hospital; NHIC Ilsan hospital; Soonchunhyang University Hospital; Ulsan University Hospital; Yonsei University
• Treatments: Interferon-alpha; Peginterferon alfa-2a

Criteria

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