Hepatitis B Research Network Pediatric Cohort Study (HBRN)
NCT ID: NCT01263600
Last Updated: 2022-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
462 participants
OBSERVATIONAL
2010-12-31
2021-06-09
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* At least 6 months to \<18 years of age
* Hepatitis B surface antigen (HBsAg) positive
Exclusion Criteria
* 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
6 Months
17 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Anna Lok
Study Chair
Principal Investigators
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Steven Belle, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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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
University of Texas Southwestern
Dallas, Texas, United States
Seattle Children's Hospital
Seattle, Washington, United States
Hospital for Sick Children
Toronto, Ontario, Canada
Countries
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References
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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.
Other Identifiers
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A-DK-3002-001
Identifier Type: OTHER
Identifier Source: secondary_id
DK082864Pediatric
Identifier Type: -
Identifier Source: org_study_id
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