Efficacy and Safety of Ypeginterferon Alfa-2b in Chronic Hepatitis C
NCT ID: NCT01140997
Last Updated: 2013-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
211 participants
INTERVENTIONAL
2010-07-31
2012-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Ypeginterferon alfa-2b 90mcg per Week, with Ribavirin 1000-1200mg/d
Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Group 2
Ypeginterferon alfa-2b 135mcg per Week, with Ribavirin 1000-1200mg/d
Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Group 3
Ypeginterferon alfa-2b 180mcg per Week, with Ribavirin 1000-1200mg/d
Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Group 4
Pegasys 180mcg per Week, with Ribavirin 1000-1200mg/d
Peginterferon alfa-2a
sc, qw, for 48 weeks.
Interventions
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Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Peginterferon alfa-2a
sc, qw, for 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wei Lai, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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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
Countries
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References
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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.
Other Identifiers
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TB1006IFN
Identifier Type: -
Identifier Source: org_study_id
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