Efficacy and Safety of Ypeginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
NCT ID: NCT01143662
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
205 participants
INTERVENTIONAL
2010-07-31
2012-04-30
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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Group 1
Ypeginterferon alfa-2b 90mcg per week
Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Group 2
Ypeginterferon alfa-2b 135mcg per week
Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Group 3
Ypeginterferon alfa-2b 180mcg per week
Ypeginterferon alfa-2b
sc, qw, for 48 weeks.
Group 4
Pegasys 180mcg per week
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.
* Serum HBsAg positive for at least 6 months.
* Serum HBeAg positive with HBV DNA ≥20,000IU/ml.
* 2×ULN≤ALT≤10×ULN at screening(ULN=upper limit of normal).
Exclusion Criteria
* Mental disorder or physical disability.
* Interferon treatment history or using nucleos(t)ide analogue for chronic hepatitis B treatment within the previous 6 months.
* WBC\<3000/mm3, or ANC \<1500/mm3, or PLT \<90,000/mm3.
* Co-infection with HAV, HIV, HCV, HDV, HEV.
* Both HBsAg and anti-HBs are positive, or both HBeAg and anti-HBe are positive at screening.
* Chest X-ray with clinically significant active inflammatory process, history of significant pulmonary disease or any history of interstitial lung disease.
* Evidence of hepatic decompensation.
* History of hypothyroidism or current treatment for thyroid disease.
* Uncontrolled significant chronic medical conditions other than chronic hepatitis B, or other conditions which in the opinion of the investigator preclude enrollment into the study.
18 Years
60 Years
ALL
No
Sponsors
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Peking University First Hospital
OTHER
Xiamen Amoytop Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Wang Guiqiang, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University First 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
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
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
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, Fourth 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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Other Identifiers
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TB1007IFN
Identifier Type: -
Identifier Source: org_study_id
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