chronic hepatitis C
Conditions
Interventions
1:The subjects who meet EVR will be treated as follows: Pegasys 180µg/wk plus Ribavirin 10.6-15mg/kg/day for totally 48 weeks.
2:The rest patients who fail to reach EVR will be randomized (1:1) into 2 study arms as follows: Pegasys 180µg/wk plus Ribavirin 10.6-15mg/kg/day for totally 72 weeks.
3:The rest patients who fail to reach EVR will be randomized (1:1) into 2 study arms as follows: Pegasys 180µg/wk plus Ribavirin 10.6-15mg/kg/day for totally 96 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.serum HCV RNA>4*10^5 IU/ml; or genotype 1b; with or without insulin resistance.
Exclusion criteria
Exclusion criteria: 1. 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); 2. Antiviral, anti-neoplastic or immuno-modulatory treatment; 3. Women with ongoing pregnancy (positive pregnancy test immediately prior to initiation of therapy) or breast feeding. 4. Co-infection with active hepatitis B, and/or human immunodeficiency virus (HIV); 5. History or other evidence of a medical condition associated with chronic liver disease other than viral hepatitis (e.g. autoimmune hepatitis); 6. Signs or symptoms of hepatocellular carcinoma, patients with a value of alpha-fetoprotein >100 ng/mL are excluded, 7. Neutrophil count 1.5 ULN at screening; 10. History of severe psychiatric disease, especially depression; History of immunologically mediated disease; History of chronic pulmonary disease associated with functional limitation; History of severe cardiac disease; History of thyroid disease poorly controlled on prescribed medications; 11. Male partners of women who are pregnant; 12. Other issues investigator think unsuitable for this trail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained Virological Response (SVR);Individual treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virological Response;Prognosis;Relapse and break-through; | — |
Countries
China
Contacts
Public ContactLai Wei
Outcome results
None listed