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New drug combo aims to tame rare liver virus

NCT ID NCT05461170

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests two experimental drugs, Elebsiran and Tobevibart, in 95 adults with chronic hepatitis D, a serious liver infection. Participants receive the drugs as injections along with a standard oral antiviral. The goal is to see if the combination can lower virus levels and improve liver health. The study is active but no longer recruiting.

What this could mean

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

Active substance
Elebsiran (VIR-2218) and Tobevibart (VIR-3434) injections, plus oral NRTI
What this could lead to
If successful, this could lead to a new treatment option that controls hepatitis D virus and reduces liver damage, potentially preventing long-term complications.
What could go wrong
This is an early-phase trial with only 95 people, so results may not apply to everyone. The drugs may not work as hoped, and side effects are still being studied.

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

95 people

The number who actually took part.

Started

Sep 2022

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 69 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: * Male or female ages 18 to \< 70 years at screening * Chronic HDV infection for \>/= 6 months * On NRTI therapy for at least 12 weeks prior to day 1 * ALT\>ULN and \< 5x ULN * Non-cirrhotic and CPT-A cirrhotic Exclusion Criteria: * Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. * History of significant liver disease from non-HBV or non-HDV etiology * History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. * History of anaphylaxis * History of immune complex disease * History of autoimmune disorder * History or evidence of alcohol or drug abuse * Prior or concomitant therapy with an immunomodulatory agent, IFN-alpha, cytotoxic or chemotherapeutic agent, or chronic corticosteroids. * Anti-HBs \>10 mIU/mL at screening

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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

  • Investigative Site

    Sofia, 1407, Bulgaria

  • Investigative Site

    Sofia, 1431, Bulgaria

  • Investigative Site

    Stara Zagora, 6003, Bulgaria

  • Investigative Site

    Clichy, 92110, France

  • Investigative Site

    Pessac, 33600, France

  • Investigative Site

    Rennes, 35000, France

  • Investigative Site

    Toulouse, 31000, France

  • Investigative Site

    Frankfurt, 60596, Germany

  • Investigative Site

    Hanover, 30625, Germany

  • Investigative Site

    Tübingen, 72076, Germany

  • Investigative Site

    Milan, 20122, Italy

  • Investigative Site

    Pisa, 56124, Italy

  • Investigative Site

    Chisinau, MD-2025, Moldova

  • Investigative Site

    Rotterdam, 3015 GD, Netherlands

  • Investigative Site

    Auckland, 1010, New Zealand

  • Investigative Site

    Bucharest, 021105, Romania

  • Investigative Site

    Birmingham, B15 2TT, United Kingdom

  • Investigative Site

    London, E1 1RF, United Kingdom

  • Investigative Site

    London, SE5 9RS, United Kingdom

  • Investigative Site

    Manchester, M8 5RB, United Kingdom

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