Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

Study Overview
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Brief Summary
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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.

Official Title
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Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy

Conditions
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Hepatitis B

Intervention / Treatment
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* Drug: Anti-HBV nucleoside/nucleotide therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with chronic HBV infection<br>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. | Drug: Anti-HBV nucleoside/nucleotide therapy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HBV, Hepatitis, Hepatitis B, OLT, MELD, Renal Safety, Liver Transplant