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3500 hepatitis b patients needed to hunt for cure biomarker

NCT ID NCT03825458

Knowledge-focused Sponsor: Hospices Civils de Lyon 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is creating a large collection of blood samples and health data from 3500 people with hepatitis B, including those who have already cleared the virus. Researchers will use these samples to look for viral RNA patterns that could signal a functional cure. No new treatments are being tested; the goal is to develop a better way to measure when the infection is under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a reliable blood test to tell when hepatitis B is functionally cured, helping doctors make better treatment decisions.
What could go wrong
This is an observational study that does not test any treatment. It only collects samples for future research, so it may not directly lead to a cure or new therapy.

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 3,500 people

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

Started

Feb 2019

Expected to finish

Jun 2029

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

Patients with hepatitis B infection (acute or chronic) or presenting with HBsAg loss (with/without anti-HBs seroconversion).

Ages

18 years and older

Sex

Anyone

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: * Adults patients and minor children over 6 years of age (in Lyon) with acute or chronic hepatitis B or presenting with HBsAg loss (with/without HBs seroconversion). (Co-infected patients with HDV and/or HCV and/or HIV are eligible) * Patients requiring blood sampling for medical care at the time of the medical appointment. * Informed patients who do not refuse to participate. * Persons not affiliated to a social security scheme and persons receiving medical assistance from the state may be asked to participate in the study Exclusion Criteria: * Patients participating at the time of the inclusion to an interventional trial evaluating a drug likely to interfere with this study. * Persons deprived of their liberty by a judicial or administrative decision * Adults who are subject to a legal protection measure * Children less than 6 years old (in Lyon)

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Conditions

The condition(s) this trial relates to.

hepatitis B virus infection

As listed by the trial registrant

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

Hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. 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

  • Department of Hepato-gastroenterology and pediatric nutrition - Hôpital Femme-Mère Enfant

    RECRUITING

    Lyon, 69677, France

  • Gastroenterology and Hepatology department - • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    TERMINATED

    Milan, 20122, Italy

  • Gastroenterology and Hepatology department - • Università degli Studi di Palermo

    TERMINATED

    Palermo, 90133, Italy

  • Hepatology department - Groupement Hospitalier Nord - Hôpital de la Croix-Rousse

    RECRUITING

    Lyon, 69004, France

  • Hôpital de la Croix-Rousse - Service de maladies infectieuses et tropicales

    RECRUITING

    Lyon, 69317, France

  • Infectious diseases and hepatology unit - Azienda Ospedaliero

    TERMINATED

    Parma, 43126, Italy

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