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Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy
Not Recruiting
Trial ID: NCT01590615
Purpose
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
Professor of Medicine (Gastroenterology and Hepatology) and, by courtesy, of Epidemiology and Population Health
Eligibility
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.
Intervention(s):
drug: Anti-HBV nucleoside/nucleotide therapy
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mindie Nguyen
650-497-6474