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Hepatitis b study tests if 'Undetectable equals Untransmissible' holds true for body fluids

NCT ID NCT07449091

Knowledge-focused Sponsor: NYU Langone Health 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether people with chronic hepatitis B who have undetectable virus levels in their blood also have undetectable levels in other body fluids like saliva or semen. Researchers will compare treated patients with suppressed virus to untreated patients with active virus. The goal is to see if the 'Undetectable = Untransmissible' message, already used for HIV, can apply to hepatitis B, which could reduce stigma and fear of transmission.

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 55 people

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

Started

May 2026

Expected to finish

Sep 2027

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

Persons with chronic hepatitis B infection and active viremia

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Infected Individuals * Individuals above 18 years and less than 65 years with chronic hepatitis B infection * Included according to undermentioned three arms: * Infected, On-treatment arm: subjects being treated with TAF/TDF for a minimum of 2 years with sustained viral suppression indicating adherence to therapy * Infected, Untreated control arm: Immune tolerant subjects; 15 with high viral load (\>10\^6) and 5 with low viral load (\<10\^6) * Uninfected Assay Validation controls: 10 subjects with history of prior infection who have convalesced i.e., have lost surface antigen, and developed surface antibody with viral eradication * Able and willing to provide informed consent Healthy Controls * Individuals above 18 years and less than 65 years who have never been infected and have been vaccinated * Able and willing to provide informed consent Exclusion Criteria: * Individuals less than 18 years or greater than 65 years of age * Prior surgery to genitourinary tract, including prior vasectomy * Prior interferon therapy * HIV co-infection * Hepatitis C virus co-infection * Hepatitis delta virus co-infection

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection Viremia

As listed by the trial registrant

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

Chronic hepatitis B Viremia

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

  • NYU Langone Health

    RECRUITING

    New York, New York, 10016, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.