- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01903278
Efficacy and Safety Study of PEG-IFN-SA and Ribavirin to Treat Chronic Hepatitis C
September 24, 2015 updated by: Cheng jun, Beijing Kawin Technology Share-Holding Co., Ltd.
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 .
Study Type
Interventional
Enrollment (Actual)
719
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Beijing, China
- Peking University First Hospital
-
Beijing, China
- Beijing Ditan Hospital, Capital Medical University
-
Beijing, China
- Beijing Youan Hospital, Capital Medical University
-
Beijing, China
- Peking University People's Hospital
-
Beijing, China
- 302 Military Hospital of China
-
Beijing, China
- Beijing Youyi Hospital, capital Medical University
-
Beijing, China
- General Hospital of Beijing Military Region
-
Chongqing, China
- The Second Affiliated Hospital of Chongqing Medical University
-
Chongqing, China
- Chongqing Southwest Hospital
-
Shanghai, China
- Shanghai Public Health Clinical Center
-
Tianjin, China
- Tianjin Infectious Disease Hospital
-
-
Gansu
-
Lanzhou, Gansu, China
- First Affiliated Hospital of Lanzhou University
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Guangzhou Eighth People's Hospital
-
Guangzhou, Guangdong, China
- Nanfang Hospital Southern Medical Unbiversity
-
-
Guangxi
-
Nanning, Guangxi, China
- The First Affiliated Hospital of Guangxi Medical University
-
-
Hebei
-
Shijiazhuang, Hebei, China
- Third Affiliated Hospital, Hebei Medical University
-
-
Heilongjiang
-
Harbin, Heilongjiang, China
- The Second Affiliated Hospital of Harbin Medical University
-
-
Henan
-
Xinxiang, Henan, China
- The First Affiliated Hospital of Xinxiang Medical University
-
Zhengzhou, Henan, China
- Henan Provincial People's Hospital
-
-
Hubei
-
Wuhan, Hubei, China
- Tongji Hospital, Tongji Medical College Huazhong University of Science & Technology
-
Wuhan, Hubei, China
- Zhongnan Hospital of Wuhan University
-
Wuhan, Hubei, China
- Union hospital, Tongji Medical College Huazhong University of Science & Technology
-
-
Hunan
-
Changsha, Hunan, China
- The Second Xiangya Hospital of Central South University
-
Changsha, Hunan, China
- Xiangya Hospital Central-South University
-
-
Jiangsu
-
Nanjing, Jiangsu, China
- Jiangsu Province Hospital
-
Nanjing, Jiangsu, China
- The Second Hospital of Nanjing
-
-
Jiangxi
-
Nanchang, Jiangxi, China
- First Affiliated Hospital of Nanchang University
-
-
Jilin
-
Changchun, Jilin, China
- The First Affiliated Hospital of Jilin University
-
Yanji, Jilin, China
- Yanbian University Hospital (Yanbian Hospital)
-
-
Liaoning
-
Shenyang, Liaoning, China
- The Sixth People's Hospital of Shenyang
-
-
Shaanxi
-
Xi'an, Shaanxi, 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
-
-
Shandong
-
Jinan, Shandong, China
- Qilu Hospital of Shandong University
-
Jinan, Shandong, China
- Jinan Infectious Disease Hospital
-
Qingdao, Shandong, China
- QingDao Municipal Hospital
-
-
Shanxi
-
Taiyuan, Shanxi, China
- The First Hospital of Shanxi Medical University
-
-
Sichuan
-
Chengdu, Sichuan, China
- West China Hospital, Sichuan University
-
Chengdu, Sichuan, China
- Sichuan Academy of Medical Science &Sichuan Provincial People's Hospital
-
-
Xinjiang
-
Urumqi, Xinjiang, China
- The First Teaching Hospital of Xinjiang Medical University
-
-
Zhejiang
-
Wenzhou, Zhejiang, China
- The First Affiliated Hospital of Wenzhou Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
|
Active Comparator: 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
|
|
Experimental: 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
|
|
Active Comparator: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SVR (sustained virologic response)
Time Frame: 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
|
24 weeks after 24 or 48 weeks of study therapy
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
RVR(rapid virologic response)
Time Frame: 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
|
weeks 4 of study therapy
|
cEVR (complete early virologic response)
Time Frame: 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
|
weeks 12 of study therapy
|
ETVR( end of treatment virologic response)
Time Frame: 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
|
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)
Time Frame: 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
|
weeks 4 and 12 of study therapy
|
No-responses
Time Frame: 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
|
weeks 12 or weeks 24 of study therapy
|
Breakthrough
Time Frame: 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)
|
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
Time Frame: 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
|
12 and 24 weeks after 24 or 48 weeks of study therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Cheng jun, MD, PhD, Beijing Ditan Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 17, 2013
First Submitted That Met QC Criteria
July 17, 2013
First Posted (Estimate)
July 19, 2013
Study Record Updates
Last Update Posted (Estimate)
September 25, 2015
Last Update Submitted That Met QC Criteria
September 24, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis, Chronic
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Peginterferon alfa-2a
Other Study ID Numbers
- KAWIN-002-2
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Chronic Hepatitis c
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Hospices Civils de LyonCompleted
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis cChina
-
Ascletis Pharmaceuticals Co., Ltd.CompletedChronic Hepatitis cChina
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
Clinical Trials on PEG-IFN-SA /RBV
-
Beijing Kawin Technology Share-Holding Co., Ltd.Completed
-
National Taiwan University HospitalNational Science Council, Taiwan; Department of Health, Executive Yuan, R.O...Completed
-
St Stephens Aids TrustCompleted
-
National Taiwan University HospitalNational Science Council, Taiwan; Department of Health, Executive Yuan, R.O...Terminated
-
Beijing Ditan HospitalBeijing YouAn Hospital; Beijing 302 Hospital/5th Medical Center of Chinese...Recruiting
-
Kirby InstituteJanssen-Cilag Ltd.CompletedHepatitis C, ChronicAustralia
-
Mitsubishi Tanabe Pharma CorporationVertex Pharmaceuticals IncorporatedCompleted
-
Gilead SciencesCompletedHepatitis CUnited States, Canada, United Kingdom, Australia, New Zealand
-
Gilead SciencesCompletedChronic Hepatitis CUnited States, Germany, Australia, United Kingdom, France, Netherlands, Canada, New Zealand, Italy, Poland, Austria, Estonia, Spain, Sweden, Puerto Rico, Czech Republic
-
Tibotec BVBACompletedChronic Hepatitis CFrance, Spain, Belgium, Germany, Austria, Netherlands