Compares two hepatitis B medicines, tenofovir alafenamide and entecavir, in chronic infection
Compares tenofovir alafenamide with entecavir in adults with chronic hepatitis B.
Key facts
- Who runs it
- Taichung Veterans General Hospital
- Where
- Taichung, TaiwanSee the site
- Trial code
- Registry title
- Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 140 people, planned
- Started
- 19 Aug 2019
- Expected to end
- 31 Dec 2030
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Tenofovir alafenamide
- Entecavir
- Record updated
- 14 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B who need antiviral treatment. It compares two drugs, tenofovir alafenamide and entecavir.
- Age
- More than 20 years old (minimum age 20 Years).
- Sex
- All sexes can join.
- Disease stage
- Chronic hepatitis B, with a need for hepatitis B virus antiviral therapy.
- Earlier treatment
- People who used nucleot(s)ide analogues for chronic hepatitis B before cannot join. People who used interferon for chronic hepatitis B within six months cannot join.
Main reasons for not taking part
- Decompensated liver disease (Child-Pugh B & C)
- End stage renal disease (eGRF < 15 ml/min/1.73m2)
- Known history of human immunodeficiency virus or hepatitis C virus co-infection
- Other uncontrolled cancer at the same time
- Pregnancy or breastfeeding
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Patients more than 20 years old
- Chronic hepatitis B patients
- Patients who were indicated for hepatitis B virus antiviral therapy
Who cannot take part
- Prior use of nucleot(s)ide analogues for chronic hepatitis B
- Prior use of interferon for chronic hepatitis B within six months
- Concurrent other uncontrolled malignancy
- Decompensated liver disease (Child-Pugh B \&C)
- End stage renal disease (eGRF < 15 ml/min/1.73m2)
- Known history of human immunodeficiency virus or hepatitis C virus co-infection
- Women in pregnancy or lactation
- Cannot conform to the study protocol of this study
Where in Taiwan
- Taichung Veterans General HospitalTaichung, TaiwanContact: Teng-Yu Lee, MD, PhDTaking people
About the trial
What the trial wants to find out
To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.
The 2 groups in the trial
- Tenofovir alafenamide groupExisting treatment, for comparison
Study subjects will receive tenofovir alafenamide 25 mg/tab once daily
Treatment: Tenofovir alafenamide
- Entecavir groupExisting treatment, for comparison
Study subjects will receive entecavir 0.5 mg/tab once daily
Treatment: Entecavir
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial
- Plain-language title
- Compares two hepatitis B medicines, tenofovir alafenamide and entecavir, in chronic infectionGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 14 May 2026