Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

Gilead Sciences54 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hepatitis B

Interventions

Anti-HBV nucleoside/nucleotide therapyDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (27)

Outcomes

Primary Outcomes

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.