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New drug combo aims to tackle stubborn hepatitis d

NCT ID NCT07128550

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This Phase 3 trial tests whether a combination of two drugs, tobevibart and elebsiran, can suppress hepatitis D virus in adults who are still infected despite taking bulevirtide. About 150 participants will receive the combo as injections. The main goal is to see if the virus becomes undetectable in the blood after 24 weeks of treatment and stays undetectable 24 weeks after treatment ends.

What this could mean

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

Active substance
Tobevibart and Elebsiran (two drugs given as injections)
What this could lead to
If successful, this combination could offer a new treatment option for people with chronic hepatitis D who are not responding to current therapy.
What could go wrong
This is an early Phase 3 trial with only 150 participants, so results may not apply to everyone. The drugs could cause side effects, and the virus might not be fully cleared.
Why investors are watching

Vir Biotechnology is running a phase 3 trial of a two-drug combination, tobevibart and elebsiran, for people with chronic hepatitis D who did not get their virus under control with the current drug bulevirtide. For a small company, this late-stage readout is a major test of whether its experimental therapy can help a difficult-to-treat group. The result will shape Vir's pipeline value and its ability to compete in a niche market.

If it works: If the combination shows strong viral suppression and a good safety profile, Vir could gain a new treatment option for hepatitis D, a disease with few approved therapies. That success could strengthen the company's position and support further development.

If it fails: Phase 3 trials often fail, and this one enrolls only 150 participants, so the results may not be conclusive. A failure or delay could hurt Vir's prospects, since the company's value depends heavily on this experimental therapy succeeding.

AI-written from the trial record. Speculative, and not investment advice.

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

About 150 people

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

Started

Jul 2025

Expected to finish

Jul 2031

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 70 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: 1. Male or female ages 18 to 70 years at screening 2. HDV RNA ≥ 500 IU/mL at screening 3. Receiving BLV 2 mg SC QD for ≥ 24 weeks at Day 1 4. Noncirrhotic or compensated cirrhotic liver disease at screening 5. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA \< 10 IU/ml at screening, currently on locally approved NRTI therapy Exclusion Criteria: 1. Serum ALT ≥ 5 × ULN 2. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation. 3. History of significant liver disease from non-HBV or non-HDV etiology 4. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients. 5. History of anaphylaxis 6. History of immune complex disease 7. History of autoimmune disorder 8. Current therapy or therapy within 24 weeks of screening with an immunomodulatory agent, immune checkpoint inhibitors, immunosuppressants, cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids.

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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

    Innsbruck, 6020, Austria

  • Investigative Site

    Vienna, 1090, Austria

  • Investigative Site

    Bobigny, 93009, France

  • Investigative Site

    Clichy, 92110, France

  • Investigative Site

    Créteil, 94000, France

  • Investigative Site

    Le Chesnay, 78150, France

  • Investigative Site

    Limoges, 87000, France

  • Investigative Site

    Lyon, 69004, France

  • Investigative Site

    Montpellier, 34295, France

  • Investigative Site

    Pessac, 33604, France

  • Investigative Site

    Rennes, 35033, France

  • Investigative Site

    Toulouse, 31059, France

  • Investigative Site

    Villejuif, 94804, France

  • Investigative Site

    Berlin, 13353, Germany

  • Investigative Site

    Essen, 45147, Germany

  • Investigative Site

    Frankfurt am Main, 60590, Germany

  • Investigative Site

    Hanover, 30625, Germany

  • Investigative Site

    Bergamo, 24127, Italy

  • Investigative Site

    Foggia, 71122, Italy

  • Investigative Site

    Milan, 20089, Italy

  • Investigative Site

    Milan, 20122, Italy

  • Investigative Site

    Pisa, 56124, Italy

  • Investigative Site

    Torino, 10122, Italy

  • Investigative Site

    Torino, 10126, Italy

  • Investigative Site

    Bucharest, 021105, Romania

  • Investigative Site

    Bucharest, 022328, Romania

  • Investigative Site

    Bucharest, 030303, Romania

  • Investigative Site

    Craiova, 200073, Romania

  • Investigative Site

    Barcelona, 08035, Spain

  • Investigative Site

    Barcelona, 08036, Spain

  • Investigative Site

    Madrid, 28007, Spain

  • Investigative Site

    Madrid, 28046, Spain

  • Investigative Site

    Santander, 39008, Spain

  • Investigative Site

    London, E1 1FR, United Kingdom

  • Investigative Site

    London, SE5 9NU, United Kingdom

  • Investigative Site

    London, W2 1NY, United Kingdom

  • Investigative Site

    Manchester, M8 5RB, United Kingdom

  • Investigative Site

    Nottingham, NG7 2UH, United Kingdom

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