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

NCT05423834 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1800

Last updated 2023-02-08

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-12-21
Completion
2026-12-31

Countries

  • Hong Kong

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05423834 on ClinicalTrials.gov