Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
- Registration Number
- NCT01903278
- Lead Sponsor
- Beijing Kawin Technology Share-Holding Co., Ltd.
- 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 .
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 719
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG-IFN-SA /RBV T1(Genotype2,3) PEG-IFN-SA /RBV 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 Pegasys /RBV C1(Genotype 2,3) Pegasys /RBV 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 Pegasys /RBV C2(Non-genotype 2,3) Pegasys /RBV 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 PEG-IFN-SA /RBV T2(Non-genotype 2,3) PEG-IFN-SA /RBV 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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
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
Trial Locations
- Locations (41)
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Beijing Youyi Hospital, capital Medical University
🇨🇳Beijing, China
Chongqing Southwest Hospital
🇨🇳Chongqing, China
The Second Hospital of Nanjing
🇨🇳Nanjing, Jiangsu, China
Yanbian University Hospital (Yanbian Hospital)
🇨🇳Yanji, Jilin, China
First Affiliated Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Nanfang Hospital Southern Medical Unbiversity
🇨🇳Guangzhou, Guangdong, China
Third Affiliated Hospital, Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The Second Affiliated Hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
Union hospital, Tongji Medical College Huazhong University of Science ＆ Technology
🇨🇳Wuhan, Hubei, China
Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology
🇨🇳Wuhan, Hubei, China
Zhongnan Hospital of Wuhan University
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central-South University
🇨🇳Changsha, Hunan, China
First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Jiangsu province hospital
🇨🇳Nanjing, Jiangsu, China
Guangzhou Eighth People's Hospital
🇨🇳Guangzhou, Guangdong, China
The First Affiliated Hospital of Jilin University
🇨🇳Changchun, Jilin, China
The Sixth People's Hospital of Shenyang
🇨🇳Shenyang, Liaoning, China
First Affiliated Hospital Of Medical College of Xian Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Second Affiliated Hospital Of Medical College of Xian Jiaotong University
🇨🇳Xi'an, Shaanxi, China
Tangdu Hospital，Fourth Military Medical University
🇨🇳Xi'an, Shaanxi, China
Jinan Infectious Disease Hospital
🇨🇳Jinan, Shandong, China
Qilu Hospital of Shandong university
🇨🇳Jinan, Shandong, China
Qingdao Municipal Hospital
🇨🇳Qingdao, Shandong, China
The First Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Sichuan Academy of Medical Science ＆Sichuan Provincial People's Hospital
🇨🇳Chengdu, Sichuan, China
West China Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
The First Teaching Hospital of Xinjiang Medical University
🇨🇳Urumqi, Xinjiang, China
The First Affiliated Hospital of Wenzhou Medical University
🇨🇳Wenzhou, Zhejiang, China
302 Military Hospital of China
🇨🇳Beijing, China
Beijing Ditan Hospital, Capital Medical University
🇨🇳Beijing, China
Beijing Youan Hospital, Capital Medical University
🇨🇳Beijing, China
The Second Affiliated Hospital of Chongqing Medical University
🇨🇳Chongqing, China
General Hospital of Beijing Military Region
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Shanghai Public Health Clinical Center
🇨🇳Shanghai, China
Tianjin Infectious Disease Hospital
🇨🇳Tianjin, China
Peking University First Hospital
🇨🇳Beijing, China