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

Recruiting

• Conditions: Chronic Hepatitis b
• Interventions: Drug: antiviral treatment

• Registration Number: NCT06289725
• Lead Sponsor: Ly Hoa Anh Minh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Study First Submitted: 2024-02-24
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-04
• Last Update Submitted: 2024-03-15
• Last Update Posted: 2024-03-18
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with genotype B	antiviral treatment	-
patients with genotype C	antiviral treatment	-

Primary Outcome Measures

Name	Time	Method
Serological response for HBeAg	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.

Secondary Outcome Measures

Name	Time	Method
Virological response	12 months after treatment	Virological response is defined as undetectable HBV DNA by a sensitive PCR assay.

Trial Locations

Locations (2)

Children's Hospital 1; 🇻🇳 Ho Chi Minh City, Vietnam

City Children's Hospital; 🇻🇳 Ho Chi Minh City, Vietnam