Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C
- Conditions
- Chronic Hepatitis C
- Interventions
- Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
- Registration Number
- NCT01596517
- Lead Sponsor
- Asan Medical Center
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 272
all of below
- adults aged 18-70 years
- serum anti-HCV antibody (+)
- HCV RNA detectable by PCR
- compensated liver disease (Child-Pugh class A)
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Korean CHC Peginterferon alfa-2a plus ribavirin for HCV genotype 1 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. Korean CHC Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of