RecruitingPhase 4

Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

Taiwan140 participantsStarted 2019-08-19

Plain-language summary

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

Who can participate

Age range

20 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients more than 20 years old
. Chronic hepatitis B patients
. Patients who were indicated for hepatitis B virus antiviral therapy

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HBV viral suppression

Timeframe: After 48-week therapy of Tenofovir alafenamide or entecavir

Renal safety: Change of estimated glomerular filtration rate

Timeframe: After 48-week therapy of Tenofovir alafenamide or entecavir

Trial details

NCT IDNCT03933384

SponsorTaichung Veterans General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Teng-Yu Lee, MD, PhD

886-4-23592525 tylee@vghtc.gov.tw

View on ClinicalTrials.gov More Hepatitis B trials