UnknownNot Applicable

The Efficacy and Safety of Tenofovir Amibufenamide to Treat Low-level Viraemia After Entecavir Treatment

China204 participantsStarted 2023-03-01

Plain-language summary

The goal of this observational study is to explore the efficacy and safety of Tenofovir Amibufenamide (TMF) in Entecavir (ETV) treated chronic hepatitis B patients with low-level viraemia. The main question it aims to answer is: * The efficacy and safety of TMF in chronic hepatitis B patients with low-level viraemia. * What is the appropriate treatment for ETV treated chronic hepatitis B patients with low-level viraemia. Participants will choose to maintain their original regimen (ETV) or switch to TMF After being fully informed of the benefits and risks of treatment. Researchers will compare ETV and TMF to see if there is a difference in the efficacy of the two drugs in chronic hepatitis B patients with low-level viraemia.

Who can participate

Age range

18 Years – 65 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

. Must be able to understand and sign a written informed consent, which must be obtained prior to screening.
. Male and non-pregnant, non-lactating female subjects who have reached the age of 18-65 years (based on the date of signed informed consent). Female subjects of childbearing age with a negative serum pregnancy test.
. Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months.
. Subjects treated with ETV over 1 year will be able to be enrolled in the study.
. Subjects with 20 ≤ HBV-DNA \< 2000 IU/mL at screening (including intermittent and continuous low-level viraeima).
. Must be willing and able to comply with all study requirements.

Exclusion criteria

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

The proportions of undetectable HBV DNA in patients treated with ETV and TMF at week 48.

Timeframe: 48 weeks

Trial details

NCT IDNCT05755776

SponsorThe Second Affiliated Hospital of Chongqing Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12

Contact for this trial

Jie Wu

+86 18652100702 wuj6@hspharm.com

View on ClinicalTrials.gov More Chronic Hepatitis B trials