Overview

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

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Asan Medical Center
Collaborators:
Gangnam Severance Hospital
Korea University Guro Hospital
Samsung Medical Center
Seoul St. Mary's Hospital
Severance Hospital
Treatments:
Interferon-alpha
Peginterferon alfa-2a
Ribavirin
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