Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
PEGIFN
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.
1 other identifier
interventional
211
1 country
38
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2010
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2010
CompletedFirst Posted
Study publicly available on registry
June 10, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedFebruary 4, 2013
June 1, 2010
6 months
June 8, 2010
January 31, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy
Proportion of patients with HCV RNA undetectable at week 12.
week 12
Secondary Outcomes (1)
Efficacy
Week 4, 12, 24, 48 and 72
Study Arms (4)
Group 1
EXPERIMENTALYpeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Group 2
EXPERIMENTALYpeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Group 3
EXPERIMENTALYpeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
Group 4
ACTIVE COMPARATORPegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Interventions
sc, qw, for 48 weeks.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
302 Military Hospital
Beijing, China
Beijing Youan Hospital, Capital Medical University
Beijing, China
Beijing Youyi Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Beijing, China
Peking University People's Hospital
Beijing, China
First Affiliated Hospital of Jilin University
Changchun, China
Xiangya Hospital, Central-south University
Changsha, China
Xiangya Second Hospital, Central-south University
Changsha, China
West China Hospital, Sichuan University
Chengdu, China
Second Affiliated Hospital Chongqing Medical University
Chongqing, China
Southwest Hospital
Chongqing, China
Fuzhou Infectious Disease Hospital
Fuzhou, China
Guangzhou Eighth People's Hospital
Guangzhou, China
Nangfang Hospital
Guangzhou, China
First Affiliated Hospital of Guangxi Medical Universtiy
Guilin, China
Second Affiliated Hospital of Harbin Medical University
Harbin, China
First Affiliated Hospital of Anhui Medical University
Hefei, China
Jinan Infectious Disease Hospital
Jinan, China
First Affiliated Hospital of Lanzhou University
Lanzhou, China
First Affiliated Hospital of Nanchang University
Nanchang, China
81 Military Hospital
Nanjing, China
Jiangsu Province Hospital
Nanjing, China
Second Hospital of Nanjing
Nanjing, China
85 Military Hospital
Shanghai, China
Changhai Hospital
Shanghai, China
Huashan Hospital
Shanghai, China
Renji Hospital
Shanghai, China
Ruijin Hospital
Shanghai, China
Shanghai Public Health Clinical Center
Shanghai, China
Shenzhen Third People's Hospital
Shenzhen, China
Third Affiliated Hospital, Hebei Medical University
Shijiazhuang, China
First Affiliated Hospital, Shanxi University
Taiyuan, China
Tianjin Third Central Hospital
Tianjin, China
First Affiliated Hospital of Wenzhou Medical College
Wenzhou, China
Tongji Hospital, Huazhong University of Science&Technology
Wuhan, China
Tangdu Hospital, Fouth Military Medical University
Xi'an, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Henan Provincial People's Hospital
Zhengzhou, China
Related Publications (1)
Feng B, Yang RF, Xie Q, Shang J, Kong FY, Zhang HY, Rao HY, Jin Q, Cong X, Liu YY, Kang Y, Wei L. Hepatitis C virus core antigen, an earlier and stronger predictor on sustained virological response in patients with genotype 1 HCV infection. BMC Gastroenterol. 2014 Mar 13;14:47. doi: 10.1186/1471-230X-14-47.
PMID: 24625322DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Lai, MD, PhD
Peking University People's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2010
First Posted
June 10, 2010
Study Start
July 1, 2010
Primary Completion
January 1, 2011
Study Completion
March 1, 2012
Last Updated
February 4, 2013
Record last verified: 2010-06