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

April 11, 2021 updated by: Xiamen Amoytop Biotech Co., Ltd.

A Multi-center, Prospective Study to Acess Long-term Benefit in HBeAg Positive Chronic Hepatitis B Patients Who Previously Received Standard Peginterferon Alfa Therapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

473

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Ditan Hospital Capital Medical University
      • Beijing, Beijing, China
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Beijing Youan Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Peking University People's Hospital
      • Beijing, Beijing, China
        • 302 Military Hospital
    • Chongqing
      • Chongqing, Chongqing, China
        • Southwest Hospital
      • Chongqing, Chongqing, China
        • Second Affiliated Hospital Chongqing Medical University
    • Fujian
      • Fuzhou, Fujian, China
        • Fuzhou Infectious Disease Hospital
      • Xiamen, Fujian, China
        • Xiamen Hospital of T.C.M
      • Xiamen, Fujian, China
        • The First Affiliated Hospital of Xiamen University
    • Guangdong
      • Guangzhou, Guangdong, China
        • Nanfang Hospital
      • Guangzhou, Guangdong, China
        • Guangzhou Eighth People's Hospital
      • Shenzhen, Guangdong, China
        • Beijing University Shenzhen Hospital
    • Hebei
      • Shijiazhuang, Hebei, China
        • Third Affiliated Hospital, Hebei Medical University
    • Henan
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital, Central-south University
      • Changsha, Hunan, China
        • Xiangya Second Hospital, Central-south University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • 81 Military Hospital
      • Nanjing, Jiangsu, China
        • Second Hospital of Nanjing
    • Jiangxi
      • Nanchang, Jiangxi, China
        • First Affiliated Hospital of Nanchang University
    • Liaoning
      • Shenyang, Liaoning, China
        • Shenyang Sixth People's Hospital
    • Shandong
      • Jinan, Shandong, China
        • Jinan Infectious Disease Hospital
    • Shanghai
      • Shanghai, Shanghai, China
        • Shanghai Public Health Clinical Center
      • Shanghai, Shanghai, China
        • Ruijing Hospital
      • Shanghai, Shanghai, China
        • 85 Military Hospital
      • Shanghai, Shanghai, China
        • Huashan Hospital
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Third Central Hospital
    • Zhejiang
      • Wenzhou, Zhejiang, China
        • First Affiliated Hospital of Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hepatitis B who previously participated in TB1211IFN study.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rate of HBeAg seroconversion
Time Frame: from the second year to the fifth year
from the second year to the fifth year

Secondary Outcome Measures

Outcome Measure
Time Frame
rate of HBeAg seroconversion
Time Frame: from the second year to the fifth year
from the second year to the fifth year
decent degree of HBeAg
Time Frame: from the second year to the fifth year
from the second year to the fifth year
decent degree of HBV DNA
Time Frame: from the second year to the fifth year
from the second year to the fifth year
rate of alanine aminotransferase normalization
Time Frame: from the second year to the fifth year
from the second year to the fifth year
rate of HBeAg loss
Time Frame: from the second year to the fifth year
from the second year to the fifth year
rate of HBV DNA undetectable
Time Frame: from the second year to the fifth year
from the second year to the fifth year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xiamen Amoytop Biotech Co., Ltd.

Collaborators

Peking University First Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 18, 2016

Primary Completion (Actual)

September 21, 2020

Study Completion (Actual)

September 21, 2020

Study Registration Dates

First Submitted

June 6, 2017

First Submitted That Met QC Criteria

June 7, 2017

First Posted (Actual)

June 8, 2017

Study Record Updates

Last Update Posted (Actual)

April 13, 2021

Last Update Submitted That Met QC Criteria

April 11, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB1510IFN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis B

Clinical Trials on Peginterferon Alfa-2B

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe