The Clinical Cure Project of Chronic Hepatitis B in China

April 11, 2023 updated by: Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University

A Study of Peg-interferon Treatment for Nucleos(t)Ide Analogues Suppressed Chronic Hepatitis B Patients With Low Level Hepatitis Surface Antigen

Chronic hepatitis B is a global public health problem, with nearly 700,000 deaths each year because of hepatitis B-related diseases. Recent studies have found that some patients who have used nucleot(s)ide analogues(NAs) for some period can achieve higher hepatitis B surface antigen(HBsAg) clearance rate(which is called clinical cure or functional cure) by using pegylated interferon. Patients who achieve clinical cure will further reduce liver inflammation, fibrosis and risks of liver cirrhosis and cancer in the future. This study was initiated in May 2018 and plans to recruit 30,000 eligible patients. The enrollment conditions are as follows: 1. according with the diagnosis of chronic hepatitis B in the guideline of China in 2015; 2.18-60 years old; 3. more than 1 year history of NAs therapy with HBsAg ≤1500 IU/ml, negative hepatitis e antigen and hepatitis B virus DNA<100 IU/ml; 4. no contraindications of interferon. For the above patients, pegylated interferon was used for 1-2 years(combined with NAs for at least 3 months).The primary goal of this study is to find out the optimal treatment for clinical cure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30000

Phase

  • Phase 4

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Recruiting
        • Department of Infectious Diseases, The Third Affliated Hospital of Sun Yat-sen University

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 60 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • according with the diagnosis of chronic hepatitis B in the guideline of China in 2015
  • 18-60 years old
  • more than 1 year history of nucleot(s)ide analogues therapy with HBsAg ≤1500 IU/ml, negative HBeAg and HBV DNA<100 IU/ml
  • no contraindications of interferon

Exclusion Criteria:

  • Allergy to interferon
  • Alanine transaminase >10 times of upper limit of normal(ULN) or total bilirubin >2 times of ULN
  • existing or previous decompensated liver cirrhosis
  • White blood cells or Platelet below the lower limit of normal
  • existing severe organ injury
  • combined with autoimmune diseases, psychiatric diseases, diabetes or thyroidism
  • confirmed or suspected malignant tumors
  • before or after transplantation
  • using immunosuppressor
  • pregnant or having a planned parenthood in 2 years
  • alcohol or drug addicted
  • infected by HIV
  • any conditions that is unsuitable to interferon therapy according to the doctors' judgement

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: short-course combination group
Nucleoside analogue is used during the first 3 months.
Drug: pegylated interferon-alfa
All the patients in this study will receive pegylated interferon for all course.
Experimental: full-course combination group
Nucleoside analogue is used during all the course of study.
Drug: pegylated interferon-alfa
All the patients in this study will receive pegylated interferon for all course.
Experimental: Monotherapy group
Only Peg-IFN is used during all the course of study.
Drug: pegylated interferon-alfa
All the patients in this study will receive pegylated interferon for all course.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hepatitis B surface antigen
Time Frame: up to 48 weeks
hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.
up to 48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hepatitis B surface antibody
Time Frame: up to 48 weeks
hepatitis B surface antigen should be tested by the reagents from Roche or Abbott, which is expressed by using IU/ml.
up to 48 weeks

Collaborators and Investigators

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

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 16, 2018

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2024

Study Registration Dates

First Submitted

July 13, 2019

First Submitted That Met QC Criteria

July 24, 2019

First Posted (Actual)

July 29, 2019

Study Record Updates

Last Update Posted (Actual)

April 14, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZhuFeng Project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study protocol would be shared with other researchers.

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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