Status:
ACTIVE_NOT_RECRUITING
Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-90 years
Brief Summary
Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV re...
Detailed Description
Antiviral therapy with nucleos(t)ide analogues (NAs) has revolutionized the management of chronic hepatitis B (CHB) in the last two decades.1 Entecavir (ETV), a nucleoside analogue, is one of the firs...
Eligibility Criteria
Inclusion
- Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND
- On TAF 25 mg daily as antiviral treatment for CHB (cases); OR
- On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)
Exclusion
- Previous NA treatment prior to TAF or ETV
- Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV)
- Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).
- Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers
- Non-hepatic cancer undergoing chemotherapy within last 6 months
Key Trial Info
Start Date :
September 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT05423834
Start Date
September 1 2022
End Date
December 31 2026
Last Update
February 8 2023
Active Locations (1)
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1
Prince of Wales Hospital
Shatin, Hong Kong