Trial intelligence / Profile preview

TAF for Liver Fibrosis Regression in CHB

NCT04939441Phase 4

Key facts

Status: Unknown
Start: Apr 2021
Primary completion: May 2024
Countries: 1
Modality: Small Molecules

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

Overview

Phase 4, open-label, single-arm trial of tenofovir alafenamide in Chronic Hepatitis B (CHB). Primary endpoints: Proportion of patients with fibrosis regression at 96 weeks and HBV DNA undetectable rate at 96 weeks. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

TAF group
Tenofovir alafenamide 25mg QD

Who it enrols

Treatment-naive chronic hepatitis B patients aged 18-69 with significant fibrosis (METAVIR >= F2) or cirrhosis, without decompensation or coinfection.

Endpoints

Primary

Proportion of patients with fibrosis regression96 weeks
HBV DNA undetectable rate96 weeks

Secondary

Percentage of liver stiffness decrease >= 30%96 weeks
HBV DNA undetectable rate72 weeks
ALT normalization rate96 weeks
HBeAg and HBsAg loss and seroconversion rate96 weeks
Changes in renal function96 weeks
Changes of bone mineral density96 weeks
Incidence of liver-related endpoint events96 weeks

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