Hepatitis B Research Network Pediatric Cohort Study (HBRN Cohort P)
Study Design: Cohort
Conditions: Hepatitis B, Hepatitis, Viral, Liver Diseases
Duration: 2010 – Present
# Recruitment Centers: 7
Treatment: None, observational only
Available Genotype Data: No
Image Summary: No
Transplant Type: None
Does it have dialysis patients: No
Access to samples for Hepatitis B Research Network Pediatric Cohort Study (HBRN Cohort P) is currently only available via collaboration. Please contact the parent study to ask about ancillary study opportunities.
Clinical Trials URL: http://www.clinicaltrials.gov/show/NCT01263600
will become, inactive carriers (defined as people who are HBsAg positive, HBeAg negative, and have normal ALT and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months with HBV DNA under 1,000 IU/mL). Additionally, biospecimens are collected from participants to create a repository of resources for future studies.
This study is ongoing.
Currently, only data from the baseline visit are available for request.
The primary objectives of the study are to investigate the natural history of the disease and to identify predictors of disease activation and progression in children. Specifically, the study aims to describe the clinical, virological, and immunological characteristics of participants with HBV; evaluate changes in HBV infection status and hepatitis B surface antigen (HBsAg) levels and factors associated with those changes; and assess the health-related quality of patients.
The rate of various clinical outcomes—including hepatitis exacerbation marked by alanine aminotransferase (ALT) flare, antigen loss of HBsAg or HBeAg, cirrhosis, development of hepative decompensation, heptaocellular carcinoma, death, and liver transplantation—and the factors associated with these outcomes are assessed as primary outcome measures, evaluated at 72 weeks.
Children and adolescents between the ages of 6 months and 18 years who are positive for HBsAg are eligible for the study.
Individuals who meet the following criteria are excluded:
- Evidence of hepatic decompensation or hepatocellular carcinoma
- Previous liver transplantation
- Currently undergoing hepatitis B antiviral treatment
- Known coinfection with HIV
- Unable or unwilling to return for regular follow-up
This study is ongoing.