Treatment and Prognosis of Patients With Chronic HBV Infection

May 22, 2022 updated by: Yan Huang, MD, Xiangya Hospital of Central South University

Study on the Antiviral Therapy and Prognosis of Patients With Chronic HBV Infection

Hepatitis B virus (HBV) infection is a major global health issue with 257 million chronically infected individuals. Of note, China has the largest population accounting for one third of the world's infected population. Approximately, about 300 000 people die each year due to the consequences of HBV. In 2016, the World Health Organization (WHO) proposed the goal for elimination of hepatitis B as public health threat by 2030 and China will be a major contributor towards this global goal. Currently, two approved therapeutic strategies are available including pegylated interferon (IFN) or nucleos (t) ide analogues (NA), which could suppress HBV replication and slow disease progression. Here, investigators hope to launch a cohort study to reveal the clinical features relating to therapeutic efficacy of antiviral therapy and the prognosis of patients with differential therapeutic strategies.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients with chronic HBV infection were recruited in the current study and divided in to peg-IFN-alpha alone group, NAs alone group and the combination therapy group. The serum HBV DNA level, HBV serological test and biochemical examination including serum transaminase level and AFP were recorded every three or six months. The serum, feces, urine and liver (if necessary) samples were collected during follow-up. And the clinical outcomes of patients were evaluated. The clinical and biological features of patients with different clinical outcomes will be compared to explore the factors affecting the antiviral therapeutic efficacy.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Department of Infectious Disease, Xiangya Hospital, Central South University
        • Contact:

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 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The chronic HBV-infected patients with differential antiviral strategies were recruited and separated to peg-IFN-alpha alone, NAs alone or combination treatment groups according to their antiviral therapies. The clinical outcomes of patients with differential treatments were compared during the follow-up management.

Description

Inclusion Criteria:

patients with evidence of chronic HBV infection

Exclusion Criteria:

chronic liver injury mainly caused by other reasons, such as autoimmune diseases, alcohol, drugs and so on.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
peg-IFN-alpha alone
Patients with chronic HBV infection only treated with peg-IFN-alpha
Other: Standard antiviral therapy
pegylated interferon or/and nucleos(t)ide analogues
nucleos(t)ide analogues alone
Patients with chronic HBV infection only treated with nucleos(t)ide analogues
Other: Standard antiviral therapy
pegylated interferon or/and nucleos(t)ide analogues
combination
Patients with chronic HBV infection treated with nucleos(t)ide analogues and peg-IFN-alpha
Other: Standard antiviral therapy
pegylated interferon or/and nucleos(t)ide analogues

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
virological response
Time Frame: 3 years
serum HBV DNA level below the detection limit
3 years
HBeAg seroconversion
Time Frame: 3 years
Loss of HBeAg and presence of anti-hepatitis B e antibody (anti-HBe) in a person who was previously HBeAg-positive and anti-HBe-negative
3 years
Clinical cure
Time Frame: 3 years
Sustained virological response and HBsAg clearance or with anti-HBs seroconversion, alanine aminotransferase (ALT) within the normal range, and mild or no lesions in the liver
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HBV DNA
Time Frame: 3 years
The serum HBV DNA level will be detected and reported every 3 to 6 months
3 years
HBV serological test
Time Frame: 3 years
HBV serological markers include HBsAg, anti-HBs, HBeAg, anti-HBe, hepatitis B core antibody (anti-HBc) were detected and reported every 3 months
3 years
liver function
Time Frame: 3 years
The serum levels of transaminase including ALT and aspartate aminotransferase (AST) will be collected and reported every 3 months
3 years
Alpha-fetoprotein (AFP)
Time Frame: 3 years
The serum AFP level will be detected and reported every 3 to 6 months
3 years

Collaborators and Investigators

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

Sponsor

Xiangya Hospital of Central South University

Investigators

  • Study Director: Yan Huang, Xiangya Hospital of Central South University

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)

October 25, 2021

Primary Completion (Anticipated)

October 25, 2024

Study Completion (Anticipated)

October 25, 2026

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 22, 2022

First Posted (Actual)

May 26, 2022

Study Record Updates

Last Update Posted (Actual)

May 26, 2022

Last Update Submitted That Met QC Criteria

May 22, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Xiangya HBV project

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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