Comparing Tenofovir Alafenamide and Entecavir for Chronic Hepatitis B Treatment
Official title: Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial
Run by Taichung Veterans General Hospital · NCT03933384 · Data updated 2026-11-12
This study is testing whether a newer hepatitis B medication called tenofovir alafenamide works as well as an older one called entecavir, while also being safer for the kidneys.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 20 Years and up |
| Sex | All |
| Enrollment | 140 (estimated) |
| Sponsor | Taichung Veterans General Hospital Academic / other |
| Locations | 1 site (Taichung, Taichung) |
| Status | Recruiting |
| Started | August 19, 2019 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2030 |
| Registry record updated | May 14, 2026 |
| Trial ID | NCT03933384 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 20 years old diagnosed with chronic hepatitis B who require antiviral therapy.
✕Probably not a fit
Patients with decompensated liver disease, end-stage renal disease, or those who have previously used certain antiviral therapies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to compare the efficacy and renal safety of two antiviral medications, tenofovir alafenamide (TAF) and entecavir (ETV), in patients with chronic hepatitis B. It is an open-label, randomized controlled trial where eligible participants will be assigned to receive either TAF or ETV for a duration of 3 years. The study seeks to determine if TAF, which has improved renal safety compared to older treatments, is as effective as ETV in managing chronic hepatitis B. The trial will monitor both antiviral efficacy and any potential renal side effects associated with the treatments.
Why it matters
Potential benefit: If successful, this study could provide insights into safer and equally effective treatment options for chronic hepatitis B patients.
How similar studies have gone: Previous studies have shown promising results with TAF, but this specific comparison with ETV is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients more than 20 years old 2. Chronic hepatitis B patients 3. Patients who were indicated for hepatitis B virus antiviral therapy Exclusion Criteria: 1. Decompensated liver disease (Child-Pugh B \&C) 2. End stage renal disease (eGRF \< 15 ml/min/1.73m2) 3. Prior use of nucleot(s)ide analogues for chronic hepatitis B 4. Prior use of interferon for chronic hepatitis B within six months 5. Known history of human immunodeficiency virus or hepatitis C virus co-infection 6. Concurrent other uncontrolled malignancy 7. Women in pregnancy or lactation 8. Cannot conform to the study protocol of this study
Where it's running
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Taichung Veterans General Hospital
Taichung, Taichung, Taiwan Recruiting
Study contacts
- Study coordinator: Teng-Yu Lee, MD, PhD
- Email: tylee@vghtc.gov.tw
- Phone: 886-4-23592525
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.