HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
This trial is active, not recruiting.
|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|
|San Francisco, CA||California Pacific Medical Center||no longer recruiting|
|San Francisco, CA||University of California San Francisco Medical Center||no longer recruiting|
|Boston, MA||Massachusetts General Hospital||no longer recruiting|
|Boston, MA||Beth Israel Deaconess Medical Center||no longer recruiting|
|Plymouth, MN||University of Minnesota||no longer recruiting|
|Rochester, MN||Mayo Clinic Rochester||no longer recruiting|
|Chapel Hill, NC||University of North Carolina||no longer recruiting|
|Dallas, TX||University of Texas Southwestern||no longer recruiting|
|Richmond, VA||Virginia Commonwealth University||no longer recruiting|
|Seattle, WA||Virginia Mason Medical Center||no longer recruiting|
|Seattle, WA||Harborview Medical Center||no longer recruiting|
|Toronto, Canada||University of Toronto||no longer recruiting|
Immune regulatory and activation measures
time frame: 240 weeks
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.
|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.|
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