Multi-center, Randomized, Open-label, Parallel-group, Active Controlled Study for the Efficacy and Safety of Pegylated Recombinant Consensus Interferon Variant Solution for Injection in the Treatment of Chronic Hepatitis C
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 719
- 试验地点
- 41
- 主要终点
- SVR (sustained virologic response)
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
PEG-IFN-SA /RBV T1(Genotype2,3)
PEG-IFN-SA/RBV, 1.5μg/kg/week im and RBV 1000mg-1200mg/d po bid（BW<75kg,1000mg/d; BW≥75kg, 1200mg/d）,24 weeks
干预措施: PEG-IFN-SA /RBV (Drug)
Pegasys /RBV C1(Genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 24 weeks
干预措施: Pegasys /RBV (Drug)
PEG-IFN-SA /RBV T2(Non-genotype 2,3)
PEG-IFN-SA 1.5μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
干预措施: PEG-IFN-SA /RBV (Drug)
Pegasys /RBV C2(Non-genotype 2,3)
Pegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
干预措施: Pegasys /RBV (Drug)
结局指标
主要结局
SVR (sustained virologic response)
时间窗: 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
次要结局
- 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)
- eRVR ( extended rapid virologic response)(weeks 4 and 12 of study therapy)
- cEVR (complete early virologic response)(weeks 12 of study therapy)
- RVR(rapid virologic response)(weeks 4 of study therapy)
- No-responses(weeks 12 or weeks 24 of study therapy)
- 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)
- Relapse(12 and 24 weeks after 24 or 48 weeks of study therapy)
研究者
Cheng jun
vice president
Beijing Kawin Technology Share-Holding Co., Ltd.