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Can a blue dye tame hepatitis b?

NCT ID NCT06887036

Disease control Sponsor: Fondazione Epatocentro Ticino 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Last updated Aug 21, 2026

Summary

This pilot study tests whether methylene blue, a compound with antiviral properties in lab tests, can reduce hepatitis B virus levels in people with chronic infection. Participants take methylene blue capsules for up to 6 months, with the dose possibly increasing if the initial dose is not effective. The goal is to see if the treatment lowers both the virus's genetic material (HBV DNA) and the surface antigen (HBsAg) in the blood, which could eventually help some patients stop long-term antiviral therapy.

What this could mean

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

Active substance
methylene blue
What this could lead to
If effective, methylene blue could offer a new oral treatment to reduce hepatitis B virus levels and potentially help some patients stop lifelong antiviral therapy.
What could go wrong
This is a small early-stage pilot study, so results may not apply broadly. Methylene blue may not lower virus levels enough, and side effects are 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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 10 people

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

Started

Sep 2025

Expected to finish

May 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.

Ages

18 to 79 years

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: * Signed informed consent * Age ≥ 18 and \< 80 years * Microbiologically confirmed chronic Hepatitis B Virus infection (according to the old terminology "inactive HBV carrier") * HBsAg levels within 20-15'000 IU/ml measured at the at least twice at 6-18 months apart * HBV DNA PCR levels within 1'000-20'000 IU/ml measured at least twice at 6-18 months apart * Negative pregnancy test in women of child-bearing age Exclusion Criteria: * Documented refusal to participate in the study * Known G-6-Phophatase deficiency * Treatment with a serotoninergic drug * Ongoing treatment with a nucleos(-t)ide treatment * Clinically relevant concomitant liver disease * GPT \> 2xULN * Fibroscan of \> 8.0 KPa obtained ≤ 12 months before Visit 0/Screening * HBeAg positivity * Anti HDV antibody positivity * Breastfeeding women

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection

As listed by the trial registrant

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

Chronic HBV infection

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

  • Epatocentro Ticino

    RECRUITING

    Lugano, Canton Ticino, 6900, Switzerland

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