Hepatitis B Research Network Pediatric Cohort Study (HBRN)

Status Completed

Clinical Trial Summary

The purpose of this study is to describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression.

Clinical Trial Description

•Primary Aim: o To describe participants 6 months to <18 years of age with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression Secondary Aims: - To describe clinical, virological, and immunological characteristics of participants with HBV in the US and Canada. - To evaluate changes in HBV infection status and hepatitis B surface antigen (HBsAg) levels and factors associated with those changes. - To verify whether a baseline HBsAg below 1,000 IU/mL and HBV DNA below 1,000 IU/mL is an accurate predictor of people who are, or who will become, inactive carriers, defined as people who are HBsAg positive, hepatitis B "e" antigen (HBeAg) negative, have normal alanine aminotransferase (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. - To assess the health related quality of life (HRQOL) of treatment naïve hepatitis B surface antigen (HBsAg) positive children and adolescents - To develop a bank of biospecimens (e.g., serum, plasma, DNA, liver tissue) obtained from participants with HBV infection. - To identify pediatric participants from 2 years to <18 years of age with chronic HBV infection for potential participation in treatment study to be conducted by the Hepatitis B Research Network (HBRN). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01263600
Study type	Observational
Source	University of Pittsburgh
Contact
Status	Completed
Phase
Start date	December 2010
Completion date	June 9, 2021

View Details

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