NCT01590615

Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B

Interventions

Type	Name	Description
DRUG	Anti-HBV nucleoside/nucleotide therapy	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.

Timeline

• Start date: 2012-04-26
• Primary completion: 2017-04-04
• Completion: 2017-04-04
• First posted: 2012-05-03
• Last updated: 2017-04-24

Locations

27 sites across 2 countries: United States, Canada