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

Asan Medical Center

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis C

Treatments: Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1; Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3

Study type: Interventional

Funder types: Other

Identifiers

NCT01596517

AMC2003-0059

Details and patient eligibility

About

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.

Full 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

Enrollment: 272 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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272 participants in 1 patient group

Korean CHC

Experimental group

Description:

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.

Treatment:

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

Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1