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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK082916 | U.S. NIH Grant/Contract | View source | |
| U01DK082864 | U.S. NIH Grant/Contract | View source | |
| U01DK082874 | U.S. NIH Grant/Contract | View source | |
| U01DK082944 | U.S. NIH Grant/Contract | View source | |
| U01DK082843 | U.S. NIH Grant/Contract | View source | |
| U01DK082871 | U.S. NIH Grant/Contract | View source | |
| UL1TR000423 | U.S. NIH Grant/Contract | View source | |
| UL1TR000004 | U.S. NIH Grant/Contract | View source | |
| A-DK-3002-001 | Other Identifier | Interagency Agreement |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to describe participants 6 months to <18 years of age 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.
•Primary Aim:
o To describe participants 6 months to <18 years of age 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 |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatitis exacerbation marked by alanine aminotransferase (ALT) Flare | A flare is defined as serum alanine aminotransferase (ALT) greater than or equal to 10 times the upper limit of normal which corresponds to (1 550 IU/L in females and 600 IU/L in males for 6 months - 18 months of age and 2) 350 IU/L in females and 400 IU/L in males for >18 months - < 18 years of age (12). Once a flare is detected, participants will be followed more closely until its resolution. |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients from Children's Hospitals and university medical centers in the United States and Canada
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| Name | Affiliation | Role |
|---|---|---|
| Steven Belle, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Medical Center | San Francisco | California | 94143 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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Liver biopsy tissue, blood (serum, plasma, and DNA)
| up to 288 weeks |
| Cirrhosis | The diagnosis of cirrhosis will be made by (1) liver histology, when available or In the absence of histological diagnosis, cirrhosis is defined as any one of the following
or in the absence of hepatic decompensation (any two of the following):
Once cirrhosis is diagnosed, patient follow-up should include Hepatocellular carcinoma(HCC)surveillance | up to 288 weeks |
| Hepatic Decompensation | It is likely that the development of cirrhosis and subsequent hepatic decompensation will be preceded and foreseen by the progression of fibrosis. Development of hepatic decompensation will be defined by any of the following events:
It is anticipated that there will be a small number of patients that will develop decompensation during the follow-up. | up to 288 weeks |
| Hepatocellular carcinoma (HCC) | 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 HCC) 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 HCC will be recorded. Follow-up ends with liver transplantation. | up to 288 weeks |
| Reaching 18 years of Age | Patients who reach 18 years of age and are within an adult HBRN clinical center will be offered participation in the adult cohort study and re-consented for the adult protocol. | up to 288 weeks |
| Johns Hopkins University |
| Baltimore |
| Maryland |
| 21287 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Cardinal Glennon Children's Medical Center | St Louis | Missouri | 63104 | United States |
| University of Texas Southwestern | Dallas | Texas | 75235 | United States |
| Seattle Children's Hospital | Seattle | Washington | 98015 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5g1X8 | Canada |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |