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This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with chronic HBV infection | Participants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-HBV nucleoside/nucleotide therapy | Drug | Subjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade | The proportion of participants with a confirmed increase in serum creatinine of at least one grade will be calculated as the number of participants with at least one grade increase in serum creatinine from baseline divided by the total number of subjects enrolled over the 4 years of accrual. | Baseline to Year 5 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade evaluated using the competing risk cumulative incidence framework | Baseline to Year 5 | |
| Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min |
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Key Inclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Adult participants with chronic HBV infection receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy and with decompensated liver disease at time of consent.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center for Liver Diseases and Transplantation | Los Angeles | California | 90048 | United States | ||
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| Baseline to Year 5 |
| Change in eGFR compared to eGFR at baseline by visit window | Baseline to Year 5 |
| Proportion of participants who received appropriate dosing relative to renal function | Baseline to Year 5 |
| Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event | Baseline to Year 5 |
| Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline | Baseline to Year 5 |
| Change in MELD score and liver disease status compared to MELD score at baseline by visit window | Baseline to Year 5 |
| Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL) | Baseline to Year 5 |
| The median number of renal related adverse events per participant over the evaluation period | Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term. | Baseline to Year 5 |
| University of California Los Angeles |
| Los Angeles |
| California |
| 90095 |
| United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| University of California at San Francisco Medical Center | San Francisco | California | 94143 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Jackson Memorial Hospital | Miami | Florida | 33136 | United States |
| Florida Hospital Transplant | Orlando | Florida | 32804 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Northwestern University | Chicago | Illinois | 60611 | United States |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Saint Louis University Hospital | St Louis | Missouri | 63104 | United States |
| Alegent Creighton Health | Omaha | Nebraska | 68124 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Methodist University Hospital | Memphis | Tennessee | 38104 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Baylor All Saints Medical Center | Fort Worth | Texas | 76104 | United States |
| The Methodist Hospital | Houston | Texas | 77030 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23249 | United States |
| Harborview Medical Center | Seattle | Washington | 98195 | United States |
| University of Calgary | Calgary | Alberta | T2N 4N1 | Canada |
| Vancouver General Hospital | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver ID Research and Care Centre Society | Vancouver | British Columbia | V6Z 2C7 | Canada |
| Toronto Liver Centre | Toronto | Ontario | M6H 3M1 | Canada |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| 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 |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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