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Can a newer hepatitis b drug protect babies while being gentler on their bones?

NCT ID NCT05466071

Disease control Sponsor: Xingfei Pan 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial compares two antiviral drugs, tenofovir alafenamide (TAF) and tenofovir disoproxil fumarate (TDF), in pregnant women with high hepatitis B virus levels. The goal is to see if TAF can prevent passing the virus to the baby as effectively as TDF, but with fewer side effects like bone density loss. Researchers will follow 200 women and their infants for two years, tracking infection rates, birth defects, and the mothers' liver health.

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), an antiviral drug
What this could lead to
If TAF works as well as the standard drug but with fewer side effects for babies, it could become a safer option for pregnant women with high hepatitis B levels.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to everyone. TAF's safety in pregnancy is still being studied, and unknown risks to the infant remain possible.

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.

Participants

About 200 people

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

Started

Jun 2021

Expected to finish

Dec 2026

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.

Who is studied

We enroll Child-bearing age women with chronic HBV infection, who already become middle/late pregnancy, and visit in 3 hospitals (The Third Affiliated Hospital of Guangzhou Medical University, People's Hospital of Guangzhou Huadu District and He Xian Memorial Hospital of Guangzhou Panyu District).

Ages

20 to 40 years

Sex

Female participants only

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: * Age of 20-40 years. * Positive for HBsAg ≥6 months. * HBV DNA load of ≥ 2×10\^5 IU/ml. * Gestation 24-28 weeks . * Pregnancies are orally administrated with TAF (25mg/day) or TDF (300mg/day) from 24-28 weeks of gestation. * The good compliance of patients. Exclusion Criteria: * Patients with antibodies against HIV, HCV, HDV, or other forms of chronic liver disease. * Evidence of hepatocellular carcinoma, decompensated liver disease, auto-immune hepatitis, or significant renal, cardiovascular, respiratory or neurological comorbidity. * Concurrent treatment with nephrotoxic drugs, glucocorticoids, cytotoxic drugs, nonsteroidal anti-inflammatory drugs, or immune modulators. * Ultra-sonographic evidence of fetal deformity, abnormal fetal development or placental abnormality. * Clinical signs of threatened miscarriage. * History of complication of pregnancy. * History of nucleoside analogues (NA) treatment.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection pregnancy disorder

As listed by the trial registrant

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

Chronic hepatitis B Pregnancy related

How to take part

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  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

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Contacts and locations

Locations

  • The Third Affiliated Hospital, Guangzhou Medical University

    RECRUITING

    Guangzhou, Guangdong, 510150, China

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