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Hepatitis B Research Network Adult Cohort Study — HBRN  

Hepatitis B Clinical Trial

Official title:
Observational Study of Persons With Hepatitis B Virus Infection in North America (Cohort Study)

Clinical Trial Summary

The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.

Clinical Trial Description

Aims - Primary Aim: o To describe participants 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 quantitative 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 transaminase (ALT) and HBV DNA under 1,000 IU/mL on at least two occasions over a period of at least 6 months - To develop a bank of biospecimens (e.g., serum, plasma, DNA, lymphocytes, liver tissue) obtained from participants with HBV infection - To identify participants with HBV infection who are potential candidates in one of the treatment studies to be conducted by the Hepatitis B Research Network (HBRN) - To describe the natural history of hepatitis B infection in pregnancy including the frequency of, and clinical and virological characteristics associated with, hepatic flares during pregnancy and post-partum. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01263587
Study type Observational
Source University of Pittsburgh
Contact
Status Completed
Phase
Start date December 2010
Completion date June 9, 2021
View Details
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