Trial intelligence / Profile preview

CHANGE: Tenofovir Alafenamide in Chronic Hepatitis B with Clinical Flare-up

NCT04496882Phase 4

Key facts

Status: Active, not recruiting
Start: Sep 2020
Primary completion: Jan 2025
Countries: 1
Sponsor: National Taiwan University Hospital
Modality: Small Molecules

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

Overview

Phase 4, open-label trial of tenofovir alafenamide in Chronic Hepatitis B (CHB) and hepatitis B (HBV) (2 cohorts), sponsored by National Taiwan University Hospital. Primary endpoint: Rate of virological remission (HBV DNA <20 IU/mL) at 48 weeks. Started Sep 2020; status: active, not recruiting.

Design

2 arms

Study design: Non-randomizedOpen-label

Switching therapy cohort
Patients receive Vemlidy (TAF) 25mg daily for 48 weeks
Historical continuing therapy cohort
Retrospective review of patients continuing original regimen (ETV, TDF)

Who it enrols

Chronic hepatitis B patients who received ETV or TDF for at least 1 year, achieved discontinuation criteria, and subsequently experienced a clinical relapse (HBV DNA > 2000 IU/mL, ALT > 2x ULN). Excludes patients with HCV/HDV/HIV co-infection, liver cirrhosis, or prior use of lamivudine, adefovir, or telbivudine.

Endpoints

Primary

Rate of virological remission (HBV DNA <20 IU/mL)48 weeks

Secondary

Rate of ALT normalization (ALT < 40 U/L)48 weeks
Rate of HBsAg change48 weeks
Rate of HBcrAg change48 weeks
Rate of M2BPGi level change48 weeks

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