Registry Study for Patients With Chronic HBV Receiving Nucleotide Therapy

Gilead Sciences

Status: Completed

Conditions: Hepatitis B

Treatments: Drug: Anti-HBV nucleoside/nucleotide therapy

Study type: Observational

Funder types: Industry

Identifiers

NCT01590615

GX-US-174-0172

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

54 participants in 1 patient group

Participants with chronic HBV infection

Description:

Participants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study.

Treatment:

Drug: Anti-HBV nucleoside/nucleotide therapy