Actively Recruiting

Phase 4
Age: 20Years +
All Genders
ID03933384

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial

Led by Taichung Veterans General Hospital · Updated on 2026-05-14

140

Participants Needed

1

Research Sites

156 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and kidney safety of two antiviral drugs, tenofovir alafenamide (TAF) and entecavir (ETV), for patients with chronic hepatitis B (CHB). Both drugs are recommended treatments, but TAF is a newer version designed to deliver the active medicine more efficiently and potentially cause less kidney damage compared to other similar drugs. This open-label, randomized controlled trial aims to directly compare TAF and ETV in CHB patients. Participants are randomly assigned to one of two groups: one group takes tenofovir alafenamide 25 mg once daily, and the other group takes entecavir 0.5 mg once daily. Treatment lasts for three years (144 weeks). The study monitors the antiviral effects and kidney function during and after 48 weeks of therapy, with extended follow-up at 144 weeks to assess long-term outcomes and safety. During the study, participants will have regular assessments including viral suppression of hepatitis B virus, kidney function tests measuring estimated glomerular filtration rate, liver enzyme levels, hepatitis B surface antigen loss, and bone mineral density. The trial tracks these outcomes at specified intervals to evaluate how well each drug controls the infection and its impact on kidney and bone health over the treatment period.

CONDITIONS

Brief Title

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Who Can Participate

Age: 20Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients more than 20 years old
  • Chronic hepatitis B patients
  • Patients who were indicated for hepatitis B virus antiviral therapy
Not Eligible

You will not qualify if you...

  • 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
  • Known history of human immunodeficiency virus or hepatitis C virus co-infection
  • Concurrent other uncontrolled malignancy
  • Women in pregnancy or lactation
  • Cannot conform to the study protocol of this study

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 years (144 weeks)

Participants receive either tenofovir alafenamide or entecavir daily to treat chronic hepatitis B.

Regular visits to monitor treatment and safety throughout the 3 years

Trial Site Locations

Total: 1 location

1

Taichung Veterans General Hospital

Taichung, Taichung, Taiwan

Actively Recruiting

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Research Team

T

Teng-Yu Lee, MD, PhD

H

Hsin-Ju Tsai, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

The contributions of hepatitis B virus and hepatitis C virus infections to cirrhosis and primary liver cancer worldwide.

Joseph F Perz, Gregory L Armstrong, Leigh A Farrington...

https://pubmed.ncbi.nlm.nih.gov/16879891

Significant reduction in end-stage liver diseases burden through the national viral hepatitis therapy program in Taiwan.

Chun-Ju Chiang, Ya-Wen Yang, Jin-De Chen...

https://pubmed.ncbi.nlm.nih.gov/25476749