HBRN: Immune Regulation and Costimulation in Natural History of Chronic Hepatitis B
2 other identifiers
observational
201
2 countries
12
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Longer than P75 for all trials
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 15, 2011
CompletedFirst Posted
Study publicly available on registry
February 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 22, 2026
January 1, 2026
15.8 years
February 15, 2011
January 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Immune regulatory and activation measures
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.
240 weeks
Eligibility Criteria
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).
You may qualify if:
- Providing informed consent for this ancillary study.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
California Pacific Medical Center
San Francisco, California, 94107, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
University of Minnesota
Plymouth, Minnesota, 55446, United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
University of Texas Southwestern
Dallas, Texas, 75390, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Harborview Medical Center
Seattle, Washington, 98104, United States
University of Toronto
Toronto, Ontario, ON M5G 1X8, Canada
Related Links
Biospecimen
Blood
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyong-Mi Chang, MD
University of Pennsylvania
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Gastroenterology
Study Record Dates
First Submitted
February 15, 2011
First Posted
February 17, 2011
Study Start
February 1, 2011
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 22, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share