chronic hepatitis C
Conditions
Interventions
A:Peg IFN alpha-2a is replaced by Peg IFNalpha-2b, Peg IFN alpha-2b 1.0-1.5ug/kg/wk plus Ribavirin 10.6-15mg/kg/day for 44 weeks after serum HCV RNA negative during 72-96 weeks
B:PegIFN alpha-2a is replaced by PegIFNalpha-2b: PegIFNalpha-2b 1.0-1.5ug/kg/wk plus Ribavirin 10.6-15mg/kg/day for 72-96 weeks. Stop the medication if serum HCV RNA does not turn negative
Sponsors
3rd Hospital of HeiBei Medical University
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. With the diagnosis of CHC; 2. Compensated liver diseases; 3. No ETVR or SVR at the end of traditional Interferon plus Ribavirin therapy previously.
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; patients with cirrhosis in Child-Pugh score > 6); 2. Co-infection with active hepatitis B, hepatitis D and/or human immuno- deficiency virus (HIV); 3. Neutrophil count 100 ng/mL; 6. Pregnant or breast-feeding females (positive pregnancy test immediately prior to initiation of therapy), male partners of women who are to be pregnant; 7. Serum creatinine level > 1.5 ULN at screening; 8. History of drug allergy on IFN or any compound of IFN; 9. History of drug and alcohol abuse; 10. History of autoimmune disease; History of severe psychiatric disease, especially depression; History of thyroid disease poorly controlled on prescribed medications; History of severe retinal disease; History of malignant tumor; History of chronic pulmonary disease with insufficient function; History of severe cardiac or digestive disease; History of disease aggravating anaemia; 11. Other issues that investigators consider unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sustained Virological Response (SVR);Predictive factors for therapy efficact; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virological Response, Prognosis, Break-through and Relapse; | — |
Countries
China
Contacts
Public ContactYuemin Nan
Outcome results
None listed