HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B

Status:	Active, not recruiting
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	9/28/2018
Start Date:	February 2011
End Date:	May 2020

This is an ancillary to the NIDDK-sponsored Hepatitis B Research Network (HBRN) Study Cohort
Study NCT01263587. This study will examine the balance between immune regulatory and effector
responses in hepatitis B-infected participants enrolled in the HBRN study (NCT01263587).

Aim 1: The clinical and virological status of chronic Hepatitis B (HBV) infection is defined
by distinct patterns of immune effector and regulatory responses: The investigators propose
that one or more immune regulatory are induced during chronic hepatitis B that define the
extent of immune tolerance vs. activation with associated disease activity and viremia.
Towards this end, the immune effector and regulatory responses relative to serum HBV DNA,
alanine aminotransferase (ALT), Hepatitis B e antigen (HBeAg), Hepatitis B surface antigen
(HBsAg) and liver histology will be examined in a cross-sectional manner in patients with
chronic HBV and control groups.

Aim 2: Clinical hepatitis flares during chronic hepatitis B reflect altered balance between
immune regulatory and effector responses.

Inclusion Criteria:

• Providing informed consent for this ancillary study.

Exclusion Criteria:

- Children under 18 years of age, participants with anemia

- Hgb<10 or Hct<30, congestive heart failure or chronic lung disease requiring oxygen,
active coronary artery disease with unstable angina, sepsis or renal failure, other
significant medical conditions, autoimmune disease or immunosuppression.

We found this trial at

sites

Virginia Commonwealth University

Richmond, Virginia 23298

(804) 828-0100