Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
This study is to confirm the potential effects and assess the safety of a new bio-product
 Pegylated Recombinant Consensus Interferon Variant Solution for Injection (PEG-IFN-SA) and
 Ribavirin（RBV） in the treatment of Chronic hepatitis C who have not been previously treated
 with Interferon.
Total 720 subjects are divided into two groups and treated separately according to the HCV
 genotype（genotype 2,3 and non-genotype 2,3). With 2:1 ratio between experimental group and
 positive-control group (Peginterferon alfa-2a (Pegasys) plus RBV), 216 subjects for genotype
 2,3 and 504 subjects for non-genotype2,3 will be enrolled. Accordingly, PEG-IFN-SA once
 weekly and RBV twice a day (bid) are given for 24 weeks and 48 weeks respectively to the HCV
 genotype 2,3 and the HCV non-genotype 2,3 .
Inclusion Criteria:

 -  Age 18- 65 years

 -  Body Mass Index (BMI) 18-30

 -  Chronic hepatitis C , diagnosed according to Chinese guideline of Hepatitis C (year
 2004)

 -  Detectable serum HCV-RNA by quantitative polymerase chain reaction assay and positive
 anti-HCV antibody

 -  Female subjects of childbearing age with no history of menopause and negative
 pregnancy test, both female and male( including their partners ) subjects were
 required to conduct adequate contraception since screening until the 6 months after
 treatment

 -  Volunteered to participate in this study, understood and signed an informed consent

 Exclusion Criteria:

 -  Previous IFN treated patients

 -  Hepatotoxic drugs was systematically used more than two weeks within past 6 months

 -  Systemic therapy with potent immunomodulatory agents such as adrenocorticotropic
 hormone, thymosin α1, etc more than two weeks within past 6 months, not including
 corticosteroid nasal sprays, inhaled steroids and / or topical steroids

 -  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

 -  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 above the ULN

 -  Serum creatine kinase> 3 ULN

 -  Diabetes mellitus or Poorly controlled Thyroid Diseases

 -  Poorly controlled hypertension (systolic blood pressure> 140mmHg, or diastolic blood
 pressure> 90 mmHg) with hypertension -related retinal lesions

 -  Immunodeficiency or autoimmune diseases including but not limited to inflammatory
 bowel disease, systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis,
 scleroderma, Sjogren's syndrome, autoimmune thrombocytopenia, etc.

 -  Psychiatric and nervous system disorders, including history of Psychiatric illness or
 with family history (especially depression, depressive tendencies, epilepsy and
 hysteria, etc.)

 -  Severe cardiovascular diseases (New York Heart Association functional class (NYHA) Ⅲ
 level and above, myocardial infarction occurred within past 6 months or PTCA performed
 within past 6 months, unstable angina, uncontrolled arrhythmias)

 -  Serious blood disorders (all kinds of anemia, hemophilia, etc.)

 -  Severe kidney disease (chronic kidney disease, renal insufficiency, etc.)

 -  Serious digestive diseases (gastrointestinal ulcers, colitis, etc.)

 -  Severe respiratory disease (pneumonia, chronic obstructive pulmonary disease,
 interstitial lung disease, etc.)

 -  Retinal disease (retinal exfoliation, macular hole, retinal tumors, etc.)

 -  Malignancies

 -  Function organs transplant

 -  Allergies or severe allergies, especially allergic to study drugs or any ingredients
 of the study drugs

 -  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