Chronic Hepatitis b
Conditions
Keywords
Hepatitis B, treatment response, genotype, children
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.
Interventions
The patient was treated with antiviral drugs according to the protocol of the Ministry of Health of Vietnam 2019
Sponsors
Ly Hoa Anh Minh
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Virological response | 12 months after treatment | Virological response is defined as undetectable HBV DNA by a sensitive PCR assay. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biochemical response | 12 months after treatment | Biochemical response is defined as normalisation of ALT levels |
Countries
Vietnam
Contacts
Primary ContactMinh Hoa Anh Ly
Outcome results
None listed