NCT06289725

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2026

Completed
Last Updated

March 18, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

February 24, 2024

Last Update Submit

March 15, 2024

Conditions

Chronic Hepatitis b

Keywords

Hepatitis Btreatment responsegenotypechildren

Outcome Measures

Primary Outcomes (1)

  • Serological response for HBeAg

    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 Outcomes (1)

  • Virological response

    12 months after treatment

Other Outcomes (1)

  • Biochemical response

    12 months after treatment

Study Arms (2)

patients with genotype B

Drug: antiviral treatment

patients with genotype C

Drug: antiviral treatment

Interventions

antiviral treatmentDRUG

The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019

patients with genotype Bpatients with genotype C

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Children's Hospital 1

Ho Chi Minh City, Vietnam

RECRUITING

City Children's Hospital

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (3)

  • Lee KJ, Choe BH, Choe JY, Kim JY, Jeong IS, Kim JW, Yang HR, Chang JY, Kim KM, Moon JS, Ko JS. A Multicenter Study of the Antiviral Efficacy of Entecavir Monotherapy Compared to Lamivudine Monotherapy in Children with Nucleos(t)ide-naive Chronic Hepatitis B. J Korean Med Sci. 2018 Feb 19;33(8):e63. doi: 10.3346/jkms.2018.33.e63.

    PMID: 29441755BACKGROUND

  • Kao JH, Chen PJ, Lai MY, Chen DS. Hepatitis B virus genotypes and spontaneous hepatitis B e antigen seroconversion in Taiwanese hepatitis B carriers. J Med Virol. 2004 Mar;72(3):363-9. doi: 10.1002/jmv.10534.

    PMID: 14748059RESULT

  • Chien RN, Yeh CT, Tsai SL, Chu CM, Liaw YF. Determinants for sustained HBeAg response to lamivudine therapy. Hepatology. 2003 Nov;38(5):1267-73. doi: 10.1053/jhep.2003.50458.

    PMID: 14578866RESULT

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Minh Hoa Anh Ly

CONTACT

(+84) 902352622lhaminh.ncs.nhi23@ump.edu.vn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

February 24, 2024

First Posted

March 4, 2024

Study Start

January 1, 2024

Primary Completion

January 1, 2026

Study Completion

January 1, 2026

Last Updated

March 18, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

VN(2)