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Hepatitis b drug showdown: which is safer for kidneys?

NCT ID NCT03933384

Disease control Sponsor: Taichung Veterans General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two antiviral drugs, tenofovir alafenamide (TAF) and entecavir, in 140 adults with chronic hepatitis B. The goal is to see which one controls the virus better and causes fewer kidney problems. Participants take one pill daily for about a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Tenofovir alafenamide (TAF) and entecavir
What this could lead to
If successful, this could show that TAF is as effective as entecavir at suppressing hepatitis B virus, with better kidney safety.
What could go wrong
This is a relatively small, open-label trial (not blinded), so results may be less reliable. Both drugs are already approved; the study compares them rather than testing a new cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2019

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection viral hepatitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatitis B Viral hepatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, Taichung, Taiwan

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