New hope: antiviral cocktail may block hepatitis b in newborns
NCT ID NCT04704024
First seen Jun 25, 2026 · Last updated Aug 25, 2026 · Updated 3 times
Summary
This phase 3 trial tests whether giving antiviral medication to pregnant women with hepatitis B and their newborns can prevent the virus from passing to the baby. The study involves 450 women and their infants in Africa. The goal is to find a safe and effective way to reduce mother-to-child transmission of hepatitis B.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tenofovir disoproxil fumarate (TDF) and lamivudine (3TC)
- What this could lead to
- If successful, this could provide a safe and effective way to prevent hepatitis B infection in newborns in Africa, reducing the number of children who get the disease.
- What could go wrong
- This is a single trial with 450 participants, and results may not apply to all populations. There are also risks of side effects from the antiviral drugs, and the study is still ongoing.
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 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
334 people
The number who actually took part.
- Started
-
Sep 2021
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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16 to 50 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * prenatal clinic patient, * age ≥16 years, * 14-32 weeks gestational age according to clinic dating based on LMP or ultrasound, * active hepatitis B with risk of vertical transmission (HBsAg+ AND HBV DNA \>1000 IU/ML or HbEAg+), * plan to receive follow up care and deliver at study facility, * capable of providing informed consent. Exclusion Criteria: * HIV positive (according to HIV antibody testing performed at the initial prenatal visit) * known liver cirrhosis or end-stage liver disease, * elevated liver enzymes (ALT \>150 \[5x upper limit of normal\]), * elevated serum creatinine (\>1.4 mg/dl) * currently taking tenofovir medication * allergy or intolerance to tenofovir study medication, * known fetal anomaly in the current pregnancy, * clinical illness requiring hospitalization at the time of enrollment * evidence of early labor at the time of enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.