Clinical trial NCT01596517: Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C
Official title: Efficacy and Effectiveness of Combination Therapy With Pegylated Interferon Alfa-2a and Ribavirin in Korean Patients With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis C
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Severance Hospital
name: Gangnam Severance Hospital
name: Seoul St. Mary's Hospital
name: Korea University Guro Hospital
First posted: 2012-05-11
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: The proportion of patients achieving sustained virological response (SVR)
timeFrame: at 24 weeks after cessation of treatment
Secondary outcomes:
measure: The proportion of patients achieving early virological response (EVR)
timeFrame: at 12 weeks of treatment
measure: the proportion of patients achieving complete EVR (cEVR)
timeFrame: at 12 weeks of treatment
measure: The proportion of patients achieving end-of-treatment response (ETR)
timeFrame: at week 48 for HCV genotype 1 and at week 24 for HCV genotype 2/3
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Suk Lim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heo NY, Lim YS, Lee HC, Lee YS, Kim KM, Byun KS, Han KH, Lee KS, Paik SW, Yoon SK, Suh DJ. High effectiveness of peginterferon alfa-2a plus ribavirin therapy in Korean patients with chronic hepatitis C in clinical practice. Clin Mol Hepatol. 2013 Mar;19(1):60-9. doi: 10.3350/cmh.2013.19.1.60. Epub 2013 Mar 25.