Hepatitis B
Conditions
Keywords
Hepatitis, Hepatitis B, HBV, OLT, MELD, Renal Safety, Liver Transplant
Brief summary
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.
Interventions
DRUGAnti-HBV nucleoside/nucleotide therapy
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.
Sponsors
Gilead Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Estimated glomerular filtration rate (Cockcroft-Gault method)using actual body weight of ≥ 50 mL/min at time of entry into registry * Negative serologies for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV) * No history of solid organ or bone marrow transplant * Currently receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy within 6 months of inclusion into registry Note: Other protocol defined Inclusion/
Exclusion criteria
may apply.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade | Baseline to Year 5 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min | 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 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 | — |
| 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 | Baseline to Year 5 | Renal related adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA) Preferred Term. |
| Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline | Baseline to Year 5 | — |
Countries
Canada, United States
Outcome results
None listed