Comparing Tenofovir Alafenamide and Entecavir for Chronic Hepatitis B Treatment
Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial
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 |
| Enrollment | 140 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Taichung Veterans General Hospital Academic / other |
| Locations | 1 site (Taichung, Taichung) |
| Trial ID | NCT03933384 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 20 years old diagnosed with chronic hepatitis B who require antiviral therapy.
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.
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 performed: Previous studies have shown promising results with TAF, but this specific comparison with ETV is novel.
Eligibility criteria
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 this trial is running
Taichung, Taichung
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.