Clinical trial NCT01263600: Hepatitis B Research Network Pediatric Cohort Study (HBRN)
Official title: Cohort Hepatitis B Virus (HBV) Pediatric Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis B
Keywords: Hepatitis B
HBV
Pediatric
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2010-12-20
Enrollment: 462
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients from Children's Hospitals and university medical centers in the United States and Canada

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Antigen loss: e and s
timeFrame: up to 288 weeks
Secondary outcomes:
measure: Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare
timeFrame: up to 288 weeks
measure: Cirrhosis
timeFrame: up to 288 weeks
measure: Hepatic Decompensation
timeFrame: up to 288 weeks
measure: Hepatocellular carcinoma (HCC)
timeFrame: up to 288 weeks
measure: Death
timeFrame: up to 288 weeks
measure: Liver transplantation
timeFrame: up to 288 weeks
measure: Reaching 18 years of Age
timeFrame: up to 288 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Saint Louis
country: United States
facility: Cardinal Glennon Children's Medical Center
state: Missouri
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: University of Pittsburgh
name: Steven Belle, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Di Bisceglie AM, King WC, Lisker-Melman M, Khalili M, Belle SH, Feld JJ, Ghany MG, Janssen HLA, Lau D, Lee WM, Ling SC, Cooper S, Rosenthal P, Schwarz KB, Sterling RK, Teckman JH, Terrault N; Hepatitis B Research Network (HBRN). Age, race and viral genotype are associated with the prevalence of hepatitis B e antigen in children and adults with chronic hepatitis B. J Viral Hepat. 2019 Jul;26(7):856-865. doi: 10.1111/jvh.13104. Epub 2019 May 2.