This trial is active, not recruiting.

Condition hepatitis b
Sponsor University of Pittsburgh
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date February 2011
End date May 2020
Trial size 201 participants
Trial identifier NCT01298037, DK082864 HBRN Immunology, U01DK082864


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Immune regulatory and activation measures
time frame: 240 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
Principal investigator Kyong-Mi Chang, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.