Chronic hepatitis C
Conditions
Interventions
Group A:Pegasys 180µg/wk plus Ribavirin 10.6-15mg/kg/day for 48 weeks
Group B:Pegasys 180µg/wk plus Ribavirin 10.6-15mg/kg/day for 72 weeks
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Baseline biopsy are consistent with the diagnosis of CHC; 2. Compensated liver diseases; 3. HCV RNA in serum is negative or undetectable by the end of previous treatment, but reappearance after therapy is discontinued.
Exclusion criteria
Exclusion criteria: 1. Baseline biopsy are consistent with the diagnosis of CHC; 2. Compensated liver diseases; 3. ETVR and SVR had never been reached at the end of traditional interferon plus Ribavirin therapy previously 4. HCV RNA in serum is negative or undetectable by the end of previous treatment, but reappearance after therapy is discontinued; 5. History or other evidence of decompensated liver disease (Coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypo-albuminemia, ascites, and bleeding from esophageal varices are conditions consistent with decompensated liver disease) (in patients with cirrhosis Child-Pugh score >6); 6. Antiviral, anti-neoplastic or immuno-modulatory treatment; 7. Women with ongoing pregnancy (positive pregnancy test immediately prior to initiation of therapy) or breast feeding; 8. Co-infection with active hepatitis B, and/or human immunodeficiency virus (HIV); 9. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g. autoimmune hepatitis); 10. Signs or symptoms of hepatocellular carcinoma, patients with a value of alpha-fetoprotein >100 ng/mL are excluded; 11. Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening; 12. Hemoglobin < 11.5 g/dL for females and <12.5 g/dL for men at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained Virological Response (SVR);Prediction effect factor; | — |
Secondary
| Measure | Time frame |
|---|---|
| Prognosis;Virological Response;Relapse and break-throug; | — |
Countries
China
Contacts
Public ContactLai Wei
Outcome results
None listed