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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK082864 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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).
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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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
• Providing informed consent for this ancillary study.
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Kyong-Mi Chang, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Pacific Medical Center | San Francisco | California | 94107 | United States | ||
| University of California San Francisco Medical Center |
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Blood
| 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 |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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