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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK082864 | U.S. NIH Grant/Contract | View source | |
| U01DK082843 | U.S. NIH Grant/Contract | View source | |
| U01DK082866 | U.S. NIH Grant/Contract | View source | |
| U01DK082863 | U.S. NIH Grant/Contract | View source | |
| U01DK082867 | U.S. NIH Grant/Contract | View source | |
| U01DK082871 | U.S. NIH Grant/Contract | View source | |
| U01DK082872 | U.S. NIH Grant/Contract | View source | |
| U01DK082874 | U.S. NIH Grant/Contract | View source | |
| U01DK082919 | U.S. NIH Grant/Contract | View source | |
| U01DK082923 | U.S. NIH Grant/Contract | View source | |
| U01DK082927 | U.S. NIH Grant/Contract | View source | |
| U01DK082943 | U.S. NIH Grant/Contract | View source | |
| U01DK082944 | U.S. NIH Grant/Contract | View source | |
| P30DK050306 | U.S. NIH Grant/Contract | View source | |
| A-DK-3002-001 | Other Grant/Funding Number | Interagency agreement | |
| M01RR000040 | U.S. NIH Grant/Contract | View source | |
| UL1TR000058 | U.S. NIH Grant/Contract | View source | |
| UL1TR000004 | U.S. NIH Grant/Contract | View source | |
| UL1RR024986 | U.S. NIH Grant/Contract | View source | |
| UL1TR001111 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| National Center for Research Resources (NCRR) | NIH |
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The primary purpose of this study is to describe participants with hepatitis B virus (HBV) infection and identify factors that may cause the disease to activate or worsen.
Aims
Primary Aim:
o To describe participants with hepatitis B virus (HBV) infection in a prospective cohort in the United States (US) and Canada and identify predictors of disease activation and progression
Secondary Aims:
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| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis Exacerbation marked by alanine aminotransferase (ALT) Flare | A flare is defined as serum ALT greater than or equal to 10 times the upper limit of normal which corresponds to 300 IU/L in males or 200 IU/L in females. This definition will also be applied to hepatitis B surface antigen (HBsAg) positive pregnant women whose ALT levels increase during pregnancy or postpartum. Once a flare is detected, participants will be followed more closely until its resolution. | up to 288 weeks |
| Antigen loss: e and s | Loss of these viral markers may be associated with appearance of corresponding antibodies in serum (anti-HBe or anti-HBs). HBsAg loss appears to represent a "cure" of HBV infection and is associated with reduction, but not necessarily elimination, of the risk of future complications, such as Hepatocellular carcinoma (HCC) which may occur, particularly in those who lose HBsAg at an older age (after 50 years) or after the development of cirrhosis. When HBeAg or HBsAg loss occurs, participants will be followed more closely initially and then return to the regular follow-up schedule. | up to 288 weeks |
| Cirrhosis | Once cirrhosis is diagnosed, follow-up will include hepatocellular carcinoma (HCC) surveillance. HCC surveillance will also be performed in non-cirrhotic participants who meet American Association for the Study of Liver Disease guidelines criteria. | up to 288 weeks |
| Hepatic decompensation | Development of hepatic decompensation will be defined by any of the following events:
It is anticipated that there will be a small number of participants who will develop hepatic decompensation during follow-up. | up to 288 weeks |
| Hepatocellular carcinoma (HCC) |
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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.
Inclusion criteria
Written informed consent
At least 18 years of age
Hepatitis B surface antigen (HBsAg) positive and either:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Belle, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| University of California Los Angeles |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37278302 | Derived | Lisker-Melman M, King WC, Ghany MG, Chung RT, Hinerman AS, Cloherty GA, Khalili M, Jain MK, Sulkowski M, Sterling RK. Human immunodeficiency virus coinfection differentially impacts hepatitis B virus viral markers based on hepatitis Be antigen status in patients with suppressed viremia. J Viral Hepat. 2023 Aug;30(8):700-709. doi: 10.1111/jvh.13857. Epub 2023 Jun 6. | |
| 36116752 | Derived | Sterling RK, Wahed AS, Cloherty G, Hoofnagle JH, Lee WM; Hepatitis B Research Network Investigators. Acute Hepatitis B Virus Infection in North American Adults. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1881-1892.e4. doi: 10.1016/j.cgh.2022.09.004. Epub 2022 Sep 16. |
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Liver biopsy tissue, blood (serum, plasma, and DNA)
Hepatocellular carcinoma (HCC) may be detected by routine surveillance or may become clinically apparent. The diagnosis of HCC will be made using the American Association for the Study of Liver Disease criteria. |
| up to 288 weeks |
| Death | Death may occur related to liver disease (typically hepatic decompensation or Hepatocellular carcinoma) or may occur unrelated to hepatitis B or liver disease. Date and cause of death will be recorded. | up to 288 weeks |
| Liver transplantation | Liver transplantation will be recorded upon notification. Date of transplantation, indication for transplantation, and occurrence of incidental Hepatocellular carcinoma (HCC) will be recorded. Follow-up ends with liver transplantation. | up to 288 weeks |
| Los Angeles |
| California |
| 90095 |
| United States |
| California Pacific Medical Center | San Francisco | California | 94115 | United States |
| University of California San Francisco | San Francisco | California | 94143 | United States |
| The Queen's Medial Center | Honolulu | Hawaii | 96813 | United States |
| NIH Clinical Center | Bethesda | Maryland | 20892 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Saint Louis University | St Louis | Missouri | 63104 | United States |
| Washington University | St Louis | Missouri | 63108 | United States |
| University of North Carolina | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23298 | United States |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| Harborview Medical Center | Seattle | Washington | 98104 | United States |
| Toronto Western Hospital Liver Centre | Toronto | Ontario | Canada |
| 33840726 | Derived | Khalili M, Kleiner DE, King WC, Sterling RK, Ghany MG, Chung RT, Bhan AK, Rosenthal P, Lisker-Melman M, Ramachandran R, Lok AS; ; and the Hepatitis B Research Network (HBRN). Hepatic Steatosis and Steatohepatitis in a Large North American Cohort of Adults With Chronic Hepatitis B. Am J Gastroenterol. 2021 Aug 1;116(8):1686-1697. doi: 10.14309/ajg.0000000000001257. |
| 31943262 | Derived | Evon DM, Lin HS, Khalili M, Fontana RJ, Yim C, Wahed AS, Fried MW, Hoofnagle JH; Hepatitis B Research Network (HBRN). Patient-reported outcomes in a large North American cohort living with chronic hepatitis B virus: a cross-sectional analysis. Aliment Pharmacol Ther. 2020 Feb;51(4):457-468. doi: 10.1111/apt.15618. Epub 2020 Jan 14. |
| 30974509 | Derived | Di Bisceglie AM, King WC, Lisker-Melman M, Khalili M, Belle SH, Feld JJ, Ghany MG, Janssen HLA, Lau D, Lee WM, Ling SC, Cooper S, Rosenthal P, Schwarz KB, Sterling RK, Teckman JH, Terrault N; Hepatitis B Research Network (HBRN). Age, race and viral genotype are associated with the prevalence of hepatitis B e antigen in children and adults with chronic hepatitis B. J Viral Hepat. 2019 Jul;26(7):856-865. doi: 10.1111/jvh.13104. Epub 2019 May 2. |
| 29599296 | Derived | Khalili M, Shuhart MC, Lombardero M, Feld JJ, Kleiner DE, Chung RT, Terrault NA, Lisker-Melman M, Sanyal A, Lok AS; Hepatitis B Research Network (HBRN); Harvard Consortium. Relationship Between Metabolic Syndrome, Alanine Aminotransferase Levels, and Liver Disease Severity in a Multiethnic North American Cohort With Chronic Hepatitis B. Diabetes Care. 2018 Jun;41(6):1251-1259. doi: 10.2337/dc18-0040. Epub 2018 Mar 29. |
| 27917600 | Derived | Di Bisceglie AM, Lombardero M, Teckman J, Roberts L, Janssen HL, Belle SH, Hoofnagle JH; Hepatitis B Research Network (HBRN). Determination of hepatitis B phenotype using biochemical and serological markers. J Viral Hepat. 2017 Apr;24(4):320-329. doi: 10.1111/jvh.12643. Epub 2016 Dec 5. |
| 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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