Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C

• Status: Completed
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beijing Kawin Technology Share-Holding Co., Ltd.
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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