A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C

Exclusion Criteria

• •Previous IFN treated patients
• •Co-infection with HAV, HBV, HEV, EBV, CMV and HIV
• •Evidences of hepatic decompensation, including but not limited to serum total bilirubin\> 2 times the upper limit of normal (ULN); serum albumin \<35g/L; prothrombin activity (PTA) \<60%; ascites, upper gastrointestinal bleeding and hepatic encephalopathy; Child-Pugh score B/C grade
• •Hepatotoxic drugs was used for a long time within past 6 months
• •Diagnosed with primary hepatocellular carcinoma or supported by evidences including but not limited to AFP\> l00ng/ml, suspicious liver nodules by imaging examinations
• •Liver diseases from causes other than HCV infection, including alcoholic liver disease, non-alcoholic steatohepatitis, drug-induced hepatitis, autoimmune hepatitis (antinuclear antibody titer higher than 1:100), hepatolenticular degeneration (Wilson's disease) and hemochromatosis, etc.
• •White blood cell count \<3×109/L; Neutrophil count\<1.5×109/L; platelet count\<90×109/L; hemoglobin below the lower limit of normal
• •Serum creatinine not within the normal range
• •Serum creatine kinase\> 3 ULN
• •Positive thyroid antibodies (A-TPO, A-TG)
• •Therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1 etc. within past 6 months or an anticipated usage during the period of study
• •Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
• •Severe autoimmune diseases; psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.); Serious blood disorders (all kinds of anemia, hemophilia, etc.); Severe kidney disease (chronic kidney disease, renal insufficiency, etc.); poorly controlled digestive diseases; endocrine disorders such as thyroid disease and diabetes; severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.); cardiovascular diseases (hypertension, uncontrolled coronary atherosclerotic heart disease, heart failure, etc.); retinal disease; malignancies; or unsuitable for study considered by clinician
• •Function organs transplant
• •Evidence of alcohol or drug abuse (average alcohol consumption male\> 40g / day, female\> 20g / day)
• •Pregnant or lactating women
• •Usage of prohibition drugs in this study
• •Participated in other clinical trials 3 months prior to the screening
• •Unwilling to sign the informed consent and adhere to treatment requirements
• •Other conditions not suitable for study judged by investigators