Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Serological response for HBeAg
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to 16 Years (Child)
- Sex
- All
- Accepts 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
Arms & Interventions
patients with genotype B
Intervention: antiviral treatment (Drug)
patients with genotype C
Intervention: antiviral treatment (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Virological response(12 months after treatment)
Investigators
Ly Hoa Anh Minh
PhD student
University of Medicine and Pharmacy at Ho Chi Minh City