Hepatitis B Research Network Pediatric Cohort Study (HBRN)

•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