Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C

Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01596517

Enrollment

272

Registered

2012-05-11

Start date

2003-06-30

Completion date

2012-05-31

Last updated

2012-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Brief summary

The purpose of this study is to investigate the efficacy and effectiveness of peginterferon alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.

Detailed description

A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label, uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008

Interventions

DRUGPeginterferon alfa-2a plus ribavirin for HCV genotype 1

Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight \<75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks.

DRUGPeginterferon alfa-2a plus ribavirin for HCV genotype 2/3

Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

all of below * adults aged 18-70 years * serum anti-HCV antibody (+) * HCV RNA detectable by PCR * compensated liver disease (Child-Pugh class A)

Exclusion criteria

any of below * HCV genotype other than 1, 2, or 3 * acute hepatitis C * decompensated cirrhosis or hepatocellular carcinoma * other liver disease such as hepatitis A or B, or autoimmune hepatitis * HIV Ab(+) * severe depression or other psychiatric disease * previous organ transplantation * absolute neutrophil count (ANC) \< 1,000 cells/mm3 or platelet count \< 75,000 cells/mm3, or hemoglobin (Hb) \< 13 g/dL for men, \<12 g/dL for women

Design outcomes

Primary

Measure	Time frame	Description
The proportion of patients achieving sustained virological response (SVR)	at 24 weeks after cessation of treatment	SVR is defined as a documented undetectable serum HCV RNA by PCR at 24 weeks after cessation of treatment

Secondary

Measure	Time frame	Description
The proportion of patients achieving early virological response (EVR)	at 12 weeks of treatment	EVR is defined as reduction of HCV RNA level by 2 log or more at 12 weeks of treatment
the proportion of patients achieving complete EVR (cEVR)	at 12 weeks of treatment	cEVR is defined as HCV RNA undetectable by PCR at 12 weeks of treatment
The proportion of patients achieving end-of-treatment response (ETR)	at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3	ETR is defined as HCV RNA undetectable at the end of treatment.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026