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).
Study Type
OBSERVATIONAL
Enrollment
462
University of California San Francisco Medical Center
San Francisco, California, United States
Johns Hopkins University
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States
Antigen loss: e and s
Loss of these viral markers may be associated with appearance of corresponding antibodies in serum (anti-HBe or anti-HBs). HBsAg loss appears to represent a "cure" of HBV infection and is associated with reduction, but not necessarily elimination, of the risk of future complications, such as Hepatocellular carcinoma (HCC) which may occur, particularly in those who lose HBsAg at an older age (after 50 years) or after the development of cirrhosis. When HBeAg or HBsAg loss occurs, participants will be followed more closely initially and then return to the regular follow-up schedule.
Time frame: up to 288 weeks
Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare
A flare is defined as serum alanine aminotransferase (ALT) greater than or equal to 10 times the upper limit of normal which corresponds to (1 550 IU/L in females and 600 IU/L in males for 6 months - 18 months of age and 2) 350 IU/L in females and 400 IU/L in males for \>18 months - \< 18 years of age (12). Once a flare is detected, participants will be followed more closely until its resolution.
Time frame: up to 288 weeks
Cirrhosis
The diagnosis of cirrhosis will be made by (1) liver histology, when available or In the absence of histological diagnosis, cirrhosis is defined as any one of the following * Presence of ascites or hepatic hydrothorax * Variceal or portal hypertensive bleeding * Hepatic encephalopathy * Child-Turcotte-Pugh (CTP) score of 7 or above or in the absence of hepatic decompensation (any two of the following): * Splenomegaly * Nodular liver * Platelet count below 120,000/mm3 Once cirrhosis is diagnosed, patient follow-up should include Hepatocellular carcinoma(HCC)surveillance
Time frame: up to 288 weeks
Hepatic Decompensation
It is likely that the development of cirrhosis and subsequent hepatic decompensation will be preceded and foreseen by the progression of fibrosis. Development of hepatic decompensation will be defined by any of the following events: * Ascites or hepatic hydrothorax * Variceal bleeding or portal hypertensive bleeding * Hepatic encephalopathy * Child-Turcotte-Pugh (CTP) score of 7 or above It is anticipated that there will be a small number of patients that will develop decompensation during the follow-up.
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University of Texas Southwestern
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Time frame: up to 288 weeks
Hepatocellular carcinoma (HCC)
HCC may be detected by routine surveillance or may become clinically apparent. The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria.
Time frame: up to 288 weeks
Death
Death may occur related to liver disease (typically hepatic decompensation or HCC) or may occur unrelated to hepatitis B or liver disease. Date and cause of death will be recorded.
Time frame: up to 288 weeks
Liver transplantation
Liver transplantation will be recorded upon notification. Date of transplantation, indication for transplantation, and occurrence of incidental HCC will be recorded. Follow-up ends with liver transplantation.
Time frame: up to 288 weeks
Reaching 18 years of Age
Patients who reach 18 years of age and are within an adult HBRN clinical center will be offered participation in the adult cohort study and re-consented for the adult protocol.
Time frame: up to 288 weeks