Clinical trial NCT06289725: Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
Official title: Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Hepatitis b
Keywords: Hepatitis B
treatment response
genotype
children
Lead sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 84
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Serological response for HBeAg
timeFrame: 12 months after treatment
Secondary outcomes:
measure: Virological response
timeFrame: 12 months after treatment
Other outcomes:
measure: Biochemical response
timeFrame: 12 months after treatment
Locations:
city: Ho Chi Minh City
country: Vietnam
facility: Children's Hospital 1
city: Ho Chi Minh City
country: Vietnam
facility: City Children's Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.