Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

Not Recruiting

Trial ID: NCT01590615


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

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

Stanford Investigator(s)

Mindie H. Nguyen, MD, MAS, AGAF, FAASLD
Mindie H. Nguyen, MD, MAS, AGAF, FAASLD

Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health


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.


drug: Anti-HBV nucleoside/nucleotide therapy

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mindie Nguyen