Clinical trial NCT01298037: HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
Official title: HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hepatitis B
Keywords: Immunology, Hepatitis B, HBV
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-02-17
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be recruited from multi-site clinical centers in the United States and Canada including primary care hospitals and community centers that have enrolled into the HBRN cohort study (NCT01263587).

Brief summary: 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immune regulatory and activation measures
timeFrame: 240 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: California Pacific Medical Center
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Plymouth
country: United States
facility: University of Minnesota
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Pennsylvania
name: Kyong-Mi Chang, MD
role: PRINCIPAL_INVESTIGATOR
References: