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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xiamen Amoytop Biotech Co., Ltd.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking University First Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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