Efficacy and Safety Study of Peginterferon Alfa-2b in Chinese Chronic Hepatitis C Patients
NCT ID: NCT01581398
Last Updated: 2014-10-07
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
PHASE3
770 participants
INTERVENTIONAL
2012-04-30
2014-06-30
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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A1(Genotype2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 800mg/day
Ypeginterferon alfa-2b
sc, qw, 24 weeks.
A2(Genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 800mg/day
Pegasys
sc, qw, 24 weeks.
B1(Non-genotype 2/3)
Ypeginterferon alfa-2b 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight
Ypeginterferon alfa-2b
sc, qw, 48 weeks.
B2(Non-genotype 2/3)
Pegasys 180μg/week, in combination with Ribavirin 1000-1200mg/day based on body weight.
Pegasys
sc, qw, 48 weeks.
Interventions
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Ypeginterferon alfa-2b
sc, qw, 24 weeks.
Pegasys
sc, qw, 24 weeks.
Ypeginterferon alfa-2b
sc, qw, 48 weeks.
Pegasys
sc, qw, 48 weeks.
Eligibility Criteria
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Inclusion Criteria
* Hepatitis virus C chronic infection evidences: HCV RNA or anti-HCV positive\>6 months,or other evidences supporting diagnosis of chronic hepatitis C infection
* HCV RNA≥2000IU/mL, anti-HCV positive at screening
* Pregnancy tests for female patients must be negative. All patients must take effective contraception measures during the study period
* Signed informed consent
Exclusion Criteria
* Mental or psychology disorder
* ANC\<1500/mm3, or PLT\<90,000/mm3, or Hb\<ULN(Upper limit of Normal)
* Received interferon treatment within the previous 6 months or shown no-response to previous interferon treatment
* Co-infection with HIV, HAV, HBV, HEV
* Evidence of hepatic decompensation (e.g: Child Plug≥B, prothrombin time prolonged more than 3 seconds, TBil\>2ULN, Alb\<35g/L)
* Hepatocarcinoma or suffering from any other malignant tumor
* Not well controlled endocrine diseases(e.g:thyroid disfunction, mellitus mellitus)
* Significant function damage in any major organs (e.g: heart, lung, kidney)
* Involved in other investigation within the previous 3 months
* Other conditions which in the opinion of the investigator precluding enrollment into the study (e.g: poor compliance)
18 Years
65 Years
ALL
No
Sponsors
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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
Nanfang Hospital
Guangzhou, , China
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, , China
First Affiliated Hospital of Guangxi Medical University
Guilin, , China
Affiliated Hospital of Guiyang Medical College
Guiyang, , China
First Affiliated Hospital, Zhejiang University
Hangzhou, , 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 Militay Hospital
Shanghai, , China
Huashan Hospital
Shanghai, , China
Renji Hospital
Shanghai, , China
Ruijing Hospital
Shanghai, , China
Shanghai Public Health Clinical Center
Shanghai, , 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 Xinjiang Medical University
Ürümqi, , China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, , China
Tangdu Hospital, Fourth Military Medical University
Xi'an, , China
Xijing Hospital
Xi'an, , China
The First Affiliated Hospital of Xiamen University
Xiamen, , China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Hennan Provincial People's Hospital
Zhengzhou, , China
Countries
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Other Identifiers
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TB1203IFN
Identifier Type: -
Identifier Source: org_study_id
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