Phase 4 Completed N=178 Randomized Treatment

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

Sustained Virologic Response · IL28B Polymorphism

Source: ClinicalTrials.gov NCT01378104 ↗

Enrolled (actual)

178

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcomePrimary: Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a — 52; 44 participants who achieved SVR

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Sustained Virologic Response Depending on the Dosage of Peginterferon Alfa 2a	52; 44	—
SECONDARY IL28B Polymorphism Effect on SVR	71.9; 33.3	—

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01378104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.