Evaluating how hepatitis B virus genotype affects treatment response in children
Impact of Hepatitis B Virus Genotype on Treatment Response in Children With Chronic Hepatitis B
This study is trying to see how different types of the hepatitis B virus affect how well children respond to treatment for chronic hepatitis B.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 84 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | University of Medicine and Pharmacy at Ho Chi Minh City Academic / other |
| Locations | 2 sites (Ho Chi Minh City and 1 other locations) |
| Trial ID | NCT06289725 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between hepatitis B virus genotype and treatment response in children diagnosed with chronic hepatitis B. Conducted in Ho Chi Minh City, Vietnam, the study involves a prospective cohort of pediatric patients who will be followed for at least 12 months. Blood samples will be collected for hepatitis B virus genotyping using Sanger sequencing to determine how different genotypes may influence treatment outcomes. The research aims to establish a correlation between genotype and the effectiveness of antiviral treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to under 16 years with chronic hepatitis B and specific viral load and liver enzyme criteria.
Not a fit: Patients with co-infections such as HIV or hepatitis C, or those with other chronic liver diseases, will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment strategies for children with chronic hepatitis B based on their virus genotype.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have indicated that understanding the relationship between genotype and treatment response can lead to improved outcomes in hepatitis B management.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ho Chi Minh City and 1 other locations
- Children's Hospital 1 — Ho Chi Minh City, Vietnam (Recruiting)
- City Children's Hospital — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Study coordinator: Minh Hoa Anh Ly
- Email: lhaminh.ncs.nhi23@ump.edu.vn
- Phone: (+84) 902352622
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.