- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01140997
Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C (PEGIFN)
January 31, 2013 updated by: Xiamen Amoytop Biotech Co., Ltd.
A Multi-center, Randomized, Open-label and Positive Controlled Phase II Clinical Trial to Assess Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C.
This study is a multi-center, randomized, open-label and positive controlled Phase II Clinical trial to assess the efficacy and safety of Ypeginterferon alfa-2b (with Ribavirin), once a week, in 3 dose-groups respectively, for treatment of Chronic Hepatitis C patients, with Pegasys 180mcg/week & Ribavirin as positive control.
It is aimed to establish a dose response and safety relationship sufficient to allow the subsequent design and conduct of Phase III trials, and generate the PK data in hepatitis C patients to satisfy regulatory requirements.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
211
Phase
- Phase 2
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 Youan Hospital, Capital Medical University
-
Beijing, China
- Peking University People's Hospital
-
Beijing, China
- 302 Military Hospital
-
Beijing, China
- Beijing Youyi Hospital, capital Medical University
-
Changchun, China
- First Affiliated Hospital of Jilin University
-
Changsha, China
- Xiangya Hospital, Central-south University
-
Changsha, China
- Xiangya Second Hospital, Central-south University
-
Chengdu, China
- West China Hospital, Sichuan University
-
Chongqing, China
- Southwest Hospital
-
Chongqing, China
- Second Affiliated Hospital Chongqing Medical University
-
Fuzhou, China
- Fuzhou Infectious Disease Hospital
-
Guangzhou, China
- Guangzhou Eighth People's Hospital
-
Guangzhou, China
- Nangfang Hospital
-
Guilin, China
- First Affiliated Hospital of Guangxi Medical Universtiy
-
Harbin, China
- Second Affiliated Hospital of Harbin Medical University
-
Hefei, China
- First Affiliated Hospital of Anhui Medical University
-
Jinan, China
- Jinan Infectious Disease Hospital
-
Lanzhou, China
- First Affiliated Hospital of Lanzhou University
-
Nanchang, China
- First Affiliated Hospital of Nanchang University
-
Nanjing, China
- Jiangsu Province Hospital
-
Nanjing, China
- Second Hospital of Nanjing
-
Nanjing, China
- 81 Military Hospital
-
Shanghai, China
- Ruijin Hospital
-
Shanghai, China
- Renji Hospital
-
Shanghai, China
- Shanghai Public Health Clinical Center
-
Shanghai, China
- Changhai Hospital
-
Shanghai, China
- Huashan Hospital
-
Shanghai, China
- 85 Military Hospital
-
Shenzhen, China
- Shenzhen Third People's Hospital
-
Shijiazhuang, China
- Third Affiliated Hospital, Hebei Medical University
-
Taiyuan, China
- First Affiliated Hospital, Shanxi University
-
Tianjin, China
- Tianjin Third Central Hospital
-
Wenzhou, China
- First Affiliated Hospital of Wenzhou Medical College
-
Wuhan, China
- Tongji Hospital, Huazhong University of Science&Technology
-
Xian, China
- Tangdu Hospital, Fouth Military Medical University
-
Zhengzhou, China
- Henan Provincial People's Hospital
-
Zhengzhou, China
- First Affiliated Hospital of Zhengzhou 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.
- Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the cessation of treatment.
- Chronic HCV infection evidence: HCV RNA or anti-HCV positive >6 months; liver biopsy evidence; vital signs, symptoms, exposure history, and results of laboratory test and iconography examination support diagnosis of chronic hepatitis C.
- HCV RNA≥2000IU/ml.
Exclusion Criteria:
- Pregnant or lactating women.
- Mental disorder or physical disability.
- WBC<3000/mm3, or ANC <1500/mm3, or PLT <90,000/mm3.
- Received interferon treatment within the previous 6 months or shew no response to interferon.
- Co-infection with HIV, HAV, HBV, HEV.
- Evidence of hepatic decompensation.
- Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
- History of hypothyroidism or current treatment for thyroid disease.
- Diabetes mellitus.
- Uncontrolled significant chronic medical conditions other than chronic hepatitis C or other conditions which in the opinion of the investigator preclude enrollment into the study.
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: Group 1
Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
|
sc, qw, for 48 weeks.
Other Names:
|
Experimental: Group 2
Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
|
sc, qw, for 48 weeks.
Other Names:
|
Experimental: Group 3
Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
|
sc, qw, for 48 weeks.
Other Names:
|
Active Comparator: Group 4
Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
|
sc, qw, for 48 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: week 12
|
Proportion of patients with HCV RNA undetectable at week 12.
|
week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Efficacy
Time Frame: Week 4, 12, 24, 48 and 72
|
|
Week 4, 12, 24, 48 and 72
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
July 1, 2010
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
June 8, 2010
First Submitted That Met QC Criteria
June 9, 2010
First Posted (Estimate)
June 10, 2010
Study Record Updates
Last Update Posted (Estimate)
February 4, 2013
Last Update Submitted That Met QC Criteria
January 31, 2013
Last Verified
June 1, 2010
More Information
Terms related to this study
Keywords
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
- Peginterferon alfa-2b
Other Study ID Numbers
- TB1006IFN
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
-
Hospices Civils de LyonCompleted
-
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
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States, Puerto Rico
Clinical Trials on Ypeginterferon alfa-2b
-
Xiamen Amoytop Biotech Co., Ltd.Peking University First HospitalCompletedChronic Hepatitis BChina
-
Xiamen Amoytop Biotech Co., Ltd.Peking University First HospitalCompletedChronic Hepatitis BChina
-
Xiamen Amoytop Biotech Co., Ltd.Peking University First HospitalCompleted
-
Xiamen Amoytop Biotech Co., Ltd.CompletedChronic Hepatitis CChina
-
PharmaEssentiaRecruitingPolycythemia VeraUnited States, Canada
-
BiocadCompletedHepatitis | Hepatitis C | Hepatitis C/ Human Immunodeficiency Virus CoinfectionRussian Federation
-
The University of Hong KongRecruitingMyelofibrosis | Primary Myelofibrosis, Prefibrotic StageHong Kong
-
PharmaEssentia Japan K.K.PharmaEssentiaCompleted
-
PharmaEssentiaNot yet recruitingPolycythemia Vera | Myeloproliferative Neoplasm
-
Foundation for Liver ResearchCompletedChronic Hepatitis BNetherlands, China