Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B

March 15, 2024 updated by: Ly Hoa Anh Minh
The study aimed to evaluate the relationship between hepatitis B virus genotype and treatment response in children with chronic hepatitis B with specific treatment indications. This is a prospective cohort study, with a follow-up period of at least 12 months, conducted at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam. The patient's blood was taken to be tested for hepatitis B virus genotyping using Sanger sequencing at the Center for Molecular Biomedicine Ho Chi Minh City. The research hypothesis is that genotype is related to treatment response.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

84

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

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

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with chronic hepatitis B are indicated for drug treatment antiviral treatment at Children's Hospital 1 and City Children's Hospital, Ho Chi Minh City, Vietnam.

Description

Inclusion Criteria:

  • Children from 2 years old to under 16 years old are diagnosed with hepatitis B chronic disease AND
  • HBsAg or HBV DNA: positive for at least six months AND
  • Liver enzyme ALT: continuously increased by> 70 for male and > 50 for female (> 2 x ULN) AND
  • The virus is proliferating: HBV DNA above 20,000 IU/mL (if HBeAg positive) OR HBV DNA above 2,000 IU/mL (if HBeAg negative) AND
  • A parent or legal guardian of the pediatric patient obtains consent for them to participate in research.

Exclusion Criteria:

  • HIV and hepatitis C co-infection
  • Patients have other chronic liver disease (Wilson, autoimmune hepatitis)
  • Patients are being treated with immunosuppressive drugs
  • Psychomotor retardation, cerebral palsy, brain sequelae

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
patients with genotype B
Drug: antiviral treatment
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019
patients with genotype C
Drug: antiviral treatment
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serological response for HBeAg
Time Frame: 12 months after treatment
Serological response for HBeAg applies only to patients with HBeAg-positive Chronic Hepatitis B and is defined as HBeAg loss and seroconversion to anti-HBe.
12 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Virological response
Time Frame: 12 months after treatment
Virological response is defined as undetectable HBV DNA by a sensitive PCR assay.
12 months after treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemical response
Time Frame: 12 months after treatment
Biochemical response is defined as normalisation of ALT levels
12 months after treatment

Collaborators and Investigators

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

Sponsor

Ly Hoa Anh Minh

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)

January 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

March 1, 2024

First Posted (Actual)

March 4, 2024

Study Record Updates

Last Update Posted (Actual)

March 18, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-VN01002-23932

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

product manufactured in and exported from the U.S.

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 Chronic Hepatitis b

Clinical Trials on antiviral treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe