Trial intelligence / Profile preview

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

NCT03933384Phase 4

Key facts

Status: Recruiting
Start: Aug 2019
Primary completion: Dec 2027
Countries: 1
Sponsor: Taichung Veterans General Hospital
Modality: Small Molecules

Drugs: tenofovir alafenamide
Conditions: Chronic Hepatitis B (CHB)

Overview

Phase 4, randomised, open-label trial of tenofovir alafenamide in Chronic Hepatitis B (CHB) (2 arms), sponsored by Taichung Veterans General Hospital. Primary endpoints: Hepatitis B Virus Viral Suppression at 48 weeks and Change of Estimated Glomerular Filtration Rate at 48 weeks. Started Aug 2019; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Tenofovir alafenamide group
Study subjects will receive tenofovir alafenamide 25 mg/tab once daily
Entecavir group
Study subjects will receive entecavir 0.5 mg/tab once daily

Who it enrols

Adult patients with chronic hepatitis B indicated for antiviral therapy, excluding those with decompensated liver disease, end-stage renal disease, prior use of nucleot(s)ide analogues or recent interferon use, HIV or HCV co-infection, uncontrolled malignancy, or who are pregnant/lactating.

Endpoints

Primary

Hepatitis B Virus Viral Suppression48 weeks
Change of Estimated Glomerular Filtration Rate48 weeks

Secondary

Change of Estimated Glomerular Filtration Rate144 weeks
Hepatitis B Virus Viral Suppression144 weeks
Normalization of Alanine Aminotransferase144 weeks
Hepatitis B Surface Antigen Loss144 weeks
Bone Mineral Density144 weeks

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