Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age20+
SponsorTaichung Veterans General Hospital
About this trial
To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients more than 20 years old
Chronic hepatitis B patients
Patients who were indicated for hepatitis B virus antiviral therapy
Disqualifiers
Decompensated liver disease (Child-Pugh B &C)
End stage renal disease (eGRF < 15 ml/min/1.73m2)
Prior use of nucleot(s)ide analogues for chronic hepatitis B
Prior use of interferon for chronic hepatitis B within six months
Trial design
Design model
Parallel
Treatments tested in this trial
Tenofovir alafenamide
DrugTenofovir alafenamide 25mg/tab once daily
Entecavir
DrugEntecavir 0.5mg/tab once daily
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Tenofovir alafenamide groupActive comparator 1 intervention
Group B: Entecavir groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA suppression
Time frame
After 48-week therapy of Tenofovir alafenamide or entecavir2
Renal safety: Change of estimated glomerular filtration rate
Change of estimated glomerular filtration rate
Time frame
After 48-week therapy of Tenofovir alafenamide or entecavirSecondary outcomes
1
Renal safety: Change of estimated glomerular filtration rate
Change of estimated glomerular filtration rate
Time frame
After 144-week therapy of Tenofovir alafenamide or entecavir2
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA suppression
Time frame
After 144-week therapy of Tenofovir alafenamide or entecavir3
Normalization alanine aminotransferase (ALT)
proportion of patients with ALT normalization
Time frame
After 144-week therapy of Tenofovir alafenamide or entecavir4
HBsAg loss
proportion of patients with HBsAg loss
Time frame
After 144-week therapy of Tenofovir alafenamide or entecavirSponsors and contacts
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Source ClinicalTrials.gov