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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Korean CHC

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

Group Type EXPERIMENTAL

Peginterferon alfa-2a plus ribavirin for HCV genotype 1

Intervention Type DRUG

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.

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

Intervention Type DRUG

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

Interventions

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Peginterferon 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.

Intervention Type DRUG

Peginterferon 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.

Intervention Type DRUG

Other Intervention Names

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Pegasys Copegus Pegasys Copegus

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No