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

Sponsor
Xiamen Amoytop Biotech Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03181113
Collaborator
Peking University First Hospital (Other)
473
Enrollment
28
Locations
52.1
Actual Duration (Months)
16.9
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Peginterferon Alfa-2B
  • Drug: Peginterferon Alfa-2A

Study Design

Study Type:
Observational
Actual Enrollment :
473 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy
Actual Study Start Date :
May 18, 2016
Actual Primary Completion Date :
Sep 21, 2020
Actual Study Completion Date :
Sep 21, 2020

Arms and Interventions

Arm Intervention/Treatment
peginterferon alfa 2b

Drug: Peginterferon Alfa-2B
pre-received standard peginterferon alfa-2b therapy
Other Names:
  • pegberon

    		•
    peginterferon alfa 2a

    Drug: Peginterferon Alfa-2A
    pre-received standard peginterferon alfa-2a therapy
    Other Names:
  • pegasys

    		•

    Outcome Measures

    Primary Outcome Measures

    1. rate of HBeAg seroconversion [from the second year to the fifth year]

    Secondary Outcome Measures

    1. decent degree of HBeAg [from the second year to the fifth year]

    2. decent degree of HBV DNA [from the second year to the fifth year]

    3. rate of alanine aminotransferase normalization [from the second year to the fifth year]

    4. rate of HBeAg loss [from the second year to the fifth year]

    5. rate of HBV DNA undetectable [from the second year to the fifth year]

    6. rate of HBeAg seroconversion [from the second year to the fifth year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 302 Military Hospital Beijing Beijing China
    2 Beijing Ditan Hospital Capital Medical University Beijing Beijing China
    3 Beijing Youan Hospital, Capital Medical University Beijing Beijing China
    4 Peking University First Hospital Beijing Beijing China
    5 Peking University People's Hospital Beijing Beijing China
    6 Second Affiliated Hospital Chongqing Medical University Chongqing Chongqing China
    7 Southwest Hospital Chongqing Chongqing China
    8 Fuzhou Infectious Disease Hospital Fuzhou Fujian China
    9 The First Affiliated Hospital of Xiamen University Xiamen Fujian China
    10 Xiamen Hospital of T.C.M Xiamen Fujian China
    11 Guangzhou Eighth People's Hospital Guangzhou Guangdong China
    12 Nanfang Hospital Guangzhou Guangdong China
    13 Beijing University Shenzhen Hospital Shenzhen Guangdong China
    14 Third Affiliated Hospital, Hebei Medical University Shijiazhuang Hebei China
    15 Henan Provincial People's Hospital Zhengzhou Henan China
    16 Xiangya Hospital, Central-south University Changsha Hunan China
    17 Xiangya Second Hospital, Central-south University Changsha Hunan China
    18 81 Military Hospital Nanjing Jiangsu China
    19 Second Hospital of Nanjing Nanjing Jiangsu China
    20 First Affiliated Hospital of Nanchang University Nanchang Jiangxi China
    21 Shenyang Sixth People's Hospital Shenyang Liaoning China
    22 Jinan Infectious Disease Hospital Jinan Shandong China
    23 85 Military Hospital Shanghai Shanghai China
    24 Huashan Hospital Shanghai Shanghai China
    25 Ruijing Hospital Shanghai Shanghai China
    26 Shanghai Public Health Clinical Center Shanghai Shanghai China
    27 Tianjin Third Central Hospital Tianjin Tianjin China
    28 First Affiliated Hospital of Wenzhou Medical College Wenzhou Zhejiang China

    Sponsors and Collaborators

    • Xiamen Amoytop Biotech Co., Ltd.
    • Peking University First Hospital

    Investigators

    • Principal Investigator: Guiqiang Wang, MD, Peking University First Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiamen Amoytop Biotech Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03181113
    Other Study ID Numbers:
    • TB1510IFN
    First Posted:
    Jun 8, 2017
    Last Update Posted:
    Apr 13, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xiamen Amoytop Biotech Co., Ltd.
    peginterferon alpha
    HBeAg seroconversion
    immune control
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis B
    Hepatitis B, Chronic
    Hepatitis
    Peginterferon alfa-2a
    Peginterferon alfa-2b

    Study Results

    No Results Posted as of Apr 13, 2021