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Long-term Benefit in Chronic Hepatitis B Patients After Standard Peginterferon Alfa Therapy

Completed
Conditions
Hepatitis B
Interventions
Registration Number
NCT03181113
Lead Sponsor
Xiamen Amoytop Biotech Co., Ltd.
Brief Summary

In this cohort study, patients with chronic hepatitis B who prior participated in TB1211IFN study and received at least 39 doses of peginterferon alfa will be enrolled. HBsAg/anti-HBs level, HBeAg/anti-HBe level, Serum HBV DNA load and alanine transaminase level will be test every year from the second year to the fifth year after the ending of peginterferon alfa treatment, and long-term benefit of interferon treatment will be evaluated.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
473
Inclusion Criteria
  • Understand and sign the informed consent form.
  • Participated in NCT01760122 study (TB1211IFN) and has received at least 39 doses of peginterferon.
Exclusion Criteria
  • Conditions which in the opinion of the investigator should be precluded from the study(e.g., poor compliance).

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
peginterferon alfa 2bPeginterferon Alfa-2B-
peginterferon alfa 2aPeginterferon Alfa-2A-
Primary Outcome Measures
NameTimeMethod
rate of HBeAg seroconversionfrom the second year to the fifth year
Secondary Outcome Measures
NameTimeMethod
rate of HBeAg seroconversionfrom the second year to the fifth year
decent degree of HBeAgfrom the second year to the fifth year
rate of alanine aminotransferase normalizationfrom the second year to the fifth year
rate of HBeAg lossfrom the second year to the fifth year
decent degree of HBV DNAfrom the second year to the fifth year
rate of HBV DNA undetectablefrom the second year to the fifth year

Trial Locations

Locations (28)

Peking University People's Hospital

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Beijing, Beijing, China

Second Affiliated Hospital Chongqing Medical University

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Chongqing, Chongqing, China

Southwest Hospital

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Chongqing, Chongqing, China

Xiamen Hospital of T.C.M

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Xiamen, Fujian, China

Beijing University Shenzhen Hospital

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Shenzhen, Guangdong, China

Beijing Ditan Hospital Capital Medical University

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Beijing, Beijing, China

Beijing Youan Hospital, Capital Medical University

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Beijing, Beijing, China

Fuzhou Infectious Disease Hospital

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Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

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Xiamen, Fujian, China

Henan Provincial People's Hospital

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Zhengzhou, Henan, China

Xiangya Hospital, Central-south University

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Changsha, Hunan, China

Xiangya Second Hospital, Central-south University

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Changsha, Hunan, China

302 Military Hospital

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Beijing, Beijing, China

Guangzhou Eighth People's Hospital

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Guangzhou, Guangdong, China

Nanfang Hospital

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Guangzhou, Guangdong, China

Third Affiliated Hospital, Hebei Medical University

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Shijiazhuang, Hebei, China

Huashan Hospital

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Shanghai, Shanghai, China

Shenyang Sixth People's Hospital

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Shenyang, Liaoning, China

81 Military Hospital

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Nanjing, Jiangsu, China

Ruijing Hospital

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Shanghai, Shanghai, China

Jinan Infectious Disease Hospital

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Jinan, Shandong, China

First Affiliated Hospital of Nanchang University

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Nanchang, Jiangxi, China

Tianjin Third Central Hospital

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Tianjin, Tianjin, China

Second Hospital of Nanjing

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Nanjing, Jiangsu, China

85 Military Hospital

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Shanghai, Shanghai, China

Shanghai Public Health Clinical Center

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Shanghai, Shanghai, China

First Affiliated Hospital of Wenzhou Medical College

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Wenzhou, Zhejiang, China

Peking University First Hospital

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Beijing, Beijing, China

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