A Phase Ⅱ Dose-escalating Study of PEG-IFN-SA and Ribavirin in IFN Naive Patients With Chronic Hepatitis C
Phase Ⅱ, 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
212
1 country
52
Brief Summary
This dose-escalating study is to evaluate the efficacy and the safety of different doses 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(IFN) by exploring the dose-effect relationship, while identity the optimal dose for phase Ⅲ study. In addition, population pharmacokinetic method is adopted to assess the pharmacokinetic behavior, individuals / intra-individual variability, and the possible factors for further study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2012
52 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
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 23, 2013
CompletedFirst Posted
Study publicly available on registry
July 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedOctober 20, 2014
October 1, 2014
10 months
July 23, 2013
October 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
cEVR (complete early virologic response)
defined as the proportion of patients who had undetectable plasma HCV RNA at weeks 12
weeks 12 of study therapy
Secondary Outcomes (5)
Proportion of patients who had undetectable plasma HCV RNA
weeks 4, 24, 48 of study therapy and 24 weeks after the end of treatment
HCV RNA load reduction
weeks 4, 12, 24, 48 of study therapy and 24 weeks after the end of treatment
eRVR ( extended rapid virologic response)
weeks 4 and 12 of study therapy
Breakthrough
weeks 24, 48 of study therapy
Relapse
12 and 24 weeks after the end of treatment
Study Arms (4)
A (PEG-IFN-SA /RBV low dose)
EXPERIMENTALPEG-IFN-SA 0.75μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）
B (PEG-IFN-SA /RBV middle dose)
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）
C (PEG-IFN-SA /RBV high dose)
EXPERIMENTALPEG-IFN-SA 2.0μg/kg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）
D (Pegasys /RBV)
ACTIVE COMPARATORPegasys 180μg/week and RBV 1000mg-1200mg/d bid depending on body weight(BW),（BW\<75kg，1000mg/d；BW≥75kg，1200mg/d）
Interventions
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
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
- 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
- Hepatotoxic drugs was used for a long time within past 6 months
- 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 not within the normal range
- Serum creatine kinase\> 3 ULN
- Positive thyroid antibodies (A-TPO, A-TG)
- Therapy with potent immunomodulatory agents such as adrenocorticotropic hormone, thymosin α1 etc. within past 6 months or an anticipated usage during the period of study
- Allergies or severe allergies, especially allergic to study drugs or any ingredients of the study drugs
- Severe autoimmune diseases; psychiatric and nervous system disorders, including history of Psychiatric illness or with family history (especially depression, depressive tendencies, epilepsy and hysteria, etc.); Serious blood disorders (all kinds of anemia, hemophilia, etc.); Severe kidney disease (chronic kidney disease, renal insufficiency, etc.); poorly controlled digestive diseases; endocrine disorders such as thyroid disease and diabetes; severe respiratory disease (pneumonia, chronic obstructive pulmonary disease, interstitial lung disease, etc.); cardiovascular diseases (hypertension, uncontrolled coronary atherosclerotic heart disease, heart failure, etc.); retinal disease; malignancies; or unsuitable for study considered by clinician
- Function organs transplant
- Evidence of alcohol or drug abuse (average alcohol consumption male\> 40g / day, female\> 20g / day)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (52)
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
First Affiliated Hospital of Lanzhou University
Lanzhou, Gansu, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Guangzhou Eighth People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital Southern Medical Unbiversity
Guangzhou, Guangdong, China
The third people's hospital of Shenzhen
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, 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
The first affiliated hospital of suzhou university
Suzhou, 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
Shandong Provincial Hospital
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
Xixi Hospital of Hangzhou
Hangzhou, Zhejiang, 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 Union Medical College Hospital
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
Chongqing Southwest Hospital
Chongqing, China
Daping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, China
Ruijing Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 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 2
- 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 23, 2013
First Posted
July 25, 2013
Study Start
October 1, 2012
Primary Completion
August 1, 2013
Study Completion
July 1, 2014
Last Updated
October 20, 2014
Record last verified: 2014-10