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Summary

for people ages 6 months to 17 years (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

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.

Official Title

Cohort Hepatitis B Virus (HBV) Pediatric Protocol

Details

•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).

Keywords

Hepatitis B HBV Pediatric Hepatitis Hepatitis A

Eligibility

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...

  • 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

Locations

  • University of California San Francisco Medical Center accepting new patients
    San Francisco, California, 94143, United States
  • Seattle Children's Hospital accepting new patients
    Seattle, Washington, 98015, United States
  • University of Texas Southwestern accepting new patients
    Dallas, Texas, 75235, United States
  • University of Minnesota accepting new patients
    Minneapolis, Minnesota, 55455, United States
  • Cardinal Glennon Children's Medical Center accepting new patients
    Saint Louis, Missouri, 63104, United States
  • Hospital for Sick Children accepting new patients
    Toronto, Ontario, M5g1X8, Canada
  • Johns Hopkins University accepting new patients
    Baltimore, Maryland, 21287, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of Pittsburgh
Links
The Hepatitis B Research Network study web site
ID
NCT01263600
Study Type
Observational
Last Updated
September 26, 2017
I’m interested in this study!