HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
- Conditions
- Hepatitis B
- Registration Number
- NCT01298037
- Lead Sponsor
- University of Pennsylvania
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 201
• Providing informed consent for this ancillary study.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immune regulatory and activation measures 240 weeks Immune regulatory and effector responses relative to HBV DNA, ALT and clinical outcome. HBV-specific lymphoproliferative, IFN-gamma and IL 10 responses, T cell activation and costimulatory markers (PD1, CTLA4, CD28, CD127), FoxP3+ Treg frequency, and NK frequency and expression of activating/inhibitory receptors and Dendritic cell frequency.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (12)
University of Minnesota
🇺🇸Plymouth, Minnesota, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
University of Toronto
🇨🇦Toronto, Ontario, Canada