Hepatitis B Research Network Pediatric Cohort Study (HBRN)



Status:Active, not recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:Any - 17
Updated:8/8/2018
Start Date:December 2010
End Date:May 2020

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Cohort Hepatitis B Virus (HBV) Pediatric Protocol

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).

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
We found this trial at
7
sites
4800 Sand Point Way NE
Seattle, Washington 98105
(206) 987-2000
Phone: 206-987-1036
Seattle Children's Hospital Seattle Children’s Hospital specializes in meeting the unique physical, emotional and developmental...
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3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Phone: 410-955-8769
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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Baltimore, MD
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Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-1133
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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Minneapolis, MN
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Dallas, Texas 75390
Phone: 214-456-8000
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Dallas, TX
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Saint Louis, Missouri 63104
Phone: 314-577-5647
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Saint Louis, MO
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
Phone: 415-476-7114
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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555 University Avenue
Toronto, Ontario M5G 1X8
Phone: 416-813-7734
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Toronto,
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