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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

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.

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

Keywords

Hepatitis B Hepatitis HBV OLT MELD Renal Safety Liver Transplant

Eligibility

For people ages 18 years and up

Inclusions:

  • 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

Locations

  • Stanford University
    Palo Alto, California, 94304, USA
  • Cedars-Sinai Medical Center for Liver Diseases and Transplantation
    Los Angeles, California, 90048, USA
  • University of California Los Angeles
    Los Angeles, California, 90095, USA

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT01590615
Study Type
Observational [Patient Registry]
Last Updated
May 2016