Status:
COMPLETED
Hepatitis B Research Network Pediatric Cohort Study (HBRN)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Hepatitis B
Eligibility:
All Genders
6-17 years
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 pre...
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 d...
Eligibility Criteria
Inclusion
- Written informed consent/assent as appropriate
- At least 6 months to \<18 years of age
- Hepatitis B surface antigen (HBsAg) positive
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT01263600
Start Date
December 1 2010
End Date
June 9 2021
Last Update
May 31 2022
Active Locations (7)
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1
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
2
Johns Hopkins University
Baltimore, Maryland, United States, 21287
3
University of Minnesota
Minneapolis, Minnesota, United States, 55455
4
Cardinal Glennon Children's Medical Center
St Louis, Missouri, United States, 63104