Observational Study of Persons with Hepatitis B Virus Infection in North America (Cohort Study)

Study ID
STU 072010-193

Cancer Related

Healthy Volunteers

Study Sites

  • UT Southwestern-Other
  • Clements University Hospital
  • UT Southwestern Ambulatory Services
  • Parkland Health & Hospital System

Debra Rowan

Principal Investigator
William Lee, M.D.


The HBRn will evaluate a cohort of participants with all stages of HBV infection, including those with acute infection, categorize them into various phases of HBeag-positive and HBeag-negative HBV infection and stages of HBV disease, describe the characteristics of these phases, determine the factors associated with transition from
one phase to another, and determine the rate of various clinical outcomes. Specifically, this study will:

1. Describe the occurrence of transitions among various phases of infection and stages of disease in persons with
HBeag-positive and HBeag-negative HBV infection
2. identify immunologic and virologic changes associated with those transitions
3. identify predictors of those transitions

Given that the majority of participants are expected to have normal aLT values, the study will focus on transition into phases with active liver disease.

Projects with the following objectives will be persued:
1. Descriptive epidemiology - data collected at baseline will provide a snapshot of HBV patients seen at the
HBRn centers.
2. Categoize patients into different phases of HBV infection
3. Relationship of HBV genotype to clinical, biochemical, and histological characteristics
4. Hepatitis B and pregnancy
5. Support of other studies of the HBRn - establish and maintain data, biospeciment bank(s) and other resources
for ancillary studies of the pathogenesis, diagnosis, natural history and treatment of HBV infection.

immunology Study:
Hepatitis B virus (HBV) is largely a non-cytopathic virus. Therefore, liver disease pathogenesis and viral clearance in HBV infection is believed to be immune-mediated. at the same time, HBV persists with impaired antiviral immune effector responses that are potentially regulated by multiple immune pathways, including the CD28 costimulatory receptors and immune regulatory T cells. To address aim 1 and 2 we are conducting an immunology Study that is ancillary to the niDDK-sponsored Hepatitis B Research network (HBRn) Study Cohort Study (entitled: observational Study of Persons with Hepatitis B Virus infection in north america).

Participant Eligibility

* Written informed consent

* At least 18 years of age

* HBsAg-positive and either
o Pregnant
o Anti-HDV positive
o Diagnosed with acute HBV infection or experiencing a hepatitis flare
o Immune tolerant or immune active phenotype
o Potentially eligible for the Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B ancillary study.