Efficacy and Safety of Peginterferon Alfa-2b in HBeAg Positive Chronic Hepatitis B
NCT ID: NCT01760122
Last Updated: 2015-08-31
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
820 participants
INTERVENTIONAL
2013-03-31
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Ypeginterferon Alfa-2b
Ypeginterferon alfa-2b
sc, qw, 48 weeks.
Pegasys
Pegasys
sc, qw, 48 weeks.
Interventions
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Ypeginterferon alfa-2b
sc, qw, 48 weeks.
Pegasys
sc, qw, 48 weeks.
Eligibility Criteria
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Inclusion Criteria
* Serum HBsAg or HBV DNA positive for at least 6 months.
* Serum HBsAg and HBeAg are both positive, HBV DNA ≥ 20,000IU/ml at screening.
* 2×ULN≤ ALT ≤10×ULN at screening (ULN=upper limit of normal).
* Pregnancy tests of female patients must be negative. All patients with effective birth control measures during treatment period and 6 months after the treatment.
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.
* ANC \< 1500/mm3, or PLT \< 90,000/mm3.
* Co-infection with HAV, HIV, HCV, HDV, or HEV.
* Both of HBsAg and anti-HBs are positive, or both of HBeAg and anti-HBe are positive at screening.
* Child-Pugh ≥ B, or other evidence of hepatitis decompensation (e.g.: prothrombin time prolonged more than 3 seconds, TBil \> 2ULN, Alb\<35g/L).
* Chronic hepatitis caused by any other reason except hepatitis B.
* Hepatocarcinoma or suffering from any other malignant tumor.
* Not well-controlled endocrine diseases (e.g.: thyroid dysfunction, diabetes mellitus)
* Significant function damage in any major organs (e.g.: heart, lung, kidney).
* 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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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, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Xiamen Hospital of T.C.M
Xiamen, Fujian, China
Beijing University Shenzhen Hospital
Shenzhen, Guangdong, China
302 Military Hospital
Beijing, , China
Beijing Ditan Hospital Capital Medical University
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
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
Jinan Infectious Disease Hospital
Jinan, , China
First Affiliated Hospital of Lanzhou University
Lanzhou, , China
81 Military Hospital
Nanchang, , China
First Affiliated Hospital of Nanchang University
Nanchang, , China
Jiangsu Province Hospital
Nanjing, , China
Second Hospital of Nanjing
Nanjing, , China
85 Military Hospital
Shanghai, , China
Huashan Hospital
Shanghai, , China
Ruijing Hospital
Shanghai, , China
Shanghai Public Health Clinical Center
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Shenyang Sixed People's Hospital
Shenyang, , 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
First Affiliated Hospital of Wenzhou Medical College
Wenzhou, , China
Tongji Hospital, Huazhong University of Science & 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
Henan Provincial People's Hospital
Zhengzhou, , China
Countries
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Other Identifiers
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TB1211IFN
Identifier Type: -
Identifier Source: org_study_id