Trial | NCT01596517  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ribavirin interferon alpha-2b ...

  • Study Participants

    272
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.
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
Study Started
Jun 30
2003
Primary Completion
Dec 31
2011
Study Completion
May 31
2012
Last Update
May 15
2012
Estimate

Drug 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.

  • Other names: Pegasys, Copegus

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.

  • Other names: Pegasys, Copegus

Korean CHC Experimental

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.

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
No Results Posted