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.
Cohort Hepatitis B Virus (HBV) Pediatric Protocol
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
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).
You can join if…
Open to people ages 6 months to 17 years
Written informed consent/assent as appropriate
At least 6 months to <18 years of age
Hepatitis B surface antigen (HBsAg) positive
You CAN'T join if...
Hepatocellular carcinoma (HCC)
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
University of California San Francisco Medical Centeraccepting new patients San Francisco, California, 94143, United States
Seattle Children's Hospitalaccepting new patients Seattle, Washington, 98015, United States
University of Texas Southwesternaccepting new patients Dallas, Texas, 75235, United States
University of Minnesotaaccepting new patients Minneapolis, Minnesota, 55455, United States
Cardinal Glennon Children's Medical Centeraccepting new patients St. Louis, Missouri, 63104, United States
Hospital for Sick Childrenaccepting new patients Toronto, Ontario, M5g1X8, Canada
Johns Hopkins Universityaccepting new patients Baltimore, Maryland, 21287, United States