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NCT05423834

Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Sponsor: Chinese University of Hong Kong

View on ClinicalTrials.gov

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 replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials. The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

OBSERVATIONAL

Enrollment

1800

Start Date

2022-09-01

Completion Date

2026-12-31

Last Updated

2023-02-08

Healthy Volunteers

No

Interventions

DRUG

Tenofovir alafenamide

Chronic hepatitis B patients who are receiving TAF as antiviral therapy for CHB, who were previously treatment naïve.

DRUG

Entecavir

Chronic hepatitis B patients who are receiving ETV as antiviral therapy for CHB, who were previously treatment naïve.

Locations (1)

Prince of Wales Hospital

Shatin, Hong Kong