Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C
|ClinicalTrials.gov Identifier: NCT01596517|
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : May 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C||Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 1 Drug: Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||272 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||May 2012|
Experimental: 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.
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: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.
- The proportion of patients achieving sustained virological response (SVR) [ Time Frame: 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
- The proportion of patients achieving early virological response (EVR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596517
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Young-Suk Lim, M.D., Ph.D.||Asan Medical Center|