Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
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
1 other identifier
interventional
719
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2013
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 17, 2013
CompletedFirst Posted
Study publicly available on registry
July 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedSeptember 25, 2015
September 1, 2015
2.2 years
July 17, 2013
September 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 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
24 weeks after 24 or 48 weeks of study therapy
Secondary Outcomes (7)
RVR(rapid virologic response)
weeks 4 of study therapy
cEVR (complete early virologic response)
weeks 12 of study therapy
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
No-responses
weeks 12 or weeks 24 of study therapy
- +2 more secondary outcomes
Study Arms (4)
PEG-IFN-SA /RBV T1(Genotype2,3)
EXPERIMENTALPEG-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)
ACTIVE COMPARATORPegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）for 24 weeks
PEG-IFN-SA /RBV T2(Non-genotype 2,3)
EXPERIMENTALPEG-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
Pegasys /RBV C2(Non-genotype 2,3)
ACTIVE COMPARATORPegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）for 48 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical Unbiversity
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 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
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College Huazhong University of Science ＆ Technology
Wuhan, Hubei, China
Union 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
Jiangsu province hospital
Nanjing, Jiangsu, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Affiliated Hospital of Jilin University
Changchun, Jilin, China
Yanbian University Hospital (Yanbian Hospital)
Yanji, 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
Ürümqi, 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
Beijing Youyi Hospital, capital Medical University
Beijing, China
General Hospital of Beijing Military Region
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Chongqing Southwest Hospital
Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Shanghai Public Health Clinical Center
Shanghai, China
Tianjin Infectious Disease Hospital
Tianjin, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheng jun, MD, PhD
Beijing Ditan Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice president
Study Record Dates
First Submitted
July 17, 2013
First Posted
July 19, 2013
Study Start
June 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
September 25, 2015
Record last verified: 2015-09