Hepatitis B Research Network Pediatric Cohort Study (HBRN)

Cohort Hepatitis B Virus (HBV) Pediatric Protocol

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.

•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).

Inclusion Criteria:

• Written informed consent/assent as appropriate
• At least 6 months to <18 years of age
• Hepatitis B surface antigen (HBsAg) positive

Exclusion Criteria:

• Hepatic decompensation
• Hepatocellular carcinoma (HCC)
• Liver transplantation
• Current Hepatitis B antiviral treatment (except pregnant females)
• Known coinfection with HIV (patients with hepatitis D or hepatitis C coinfection are not excluded)
• Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up.
• Unable or unwilling to return for regular follow-up