Chronic Hepatitis c
Conditions
Keywords
interferon, ribavirin, sustained virological response
Brief 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.
Detailed description
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 .
Interventions
DRUGPEG-IFN-SA /RBV
DRUGPegasys /RBV
Sponsors
Beijing Kawin Technology Share-Holding Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SVR (sustained virologic response) | 24 weeks after 24 or 48 weeks of study therapy | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at 24 weeks after the end of SVR (sustained virologic response) defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at 24 weeks after the end of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cEVR (complete early virologic response) | weeks 12 of study therapy | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at weeks 12 |
| ETVR( end of treatment virologic response) | weeks 24 of study therapy for genotype 2,3, and weeks 48 of study therapy for non-genotype 2,3 | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at the end of treatment |
| eRVR ( extended rapid virologic response) | weeks 4 and 12 of study therapy | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at weeks 4 and 12 |
| RVR(rapid virologic response) | weeks 4 of study therapy | defined as the proportion of patients who had undetectable plasma HCV RNA (HCV RNA \< 15 IU/mL) at weeks 4 |
| Breakthrough | weeks 12, 24 of study therapy for genotype 2,3, and weeks 12, 24 and 48 of study therapy for non-genotype 2,3 | defined as the proportion of patients who had detectable plasma HCV RNA at any point during treatment after virological response( undetectable plasma HCV RNA) |
| Relapse | 12 and 24 weeks after 24 or 48 weeks of study therapy | defined as the proportion of patients who had undetectable HCV RNA at the end of treatment, but reappearance of HCV RNA after the then |
| No-responses | weeks 12 or weeks 24 of study therapy | defined as the proportion of patients who had less than a \<2 log IU/ml plasma HCV RNA decline at weeks 12 or had detectable plasma HCV RNA at weeks 24 |
Countries
China
Outcome results
None listed