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New hope for hepatitis delta: can switching drugs clear the virus?

NCT ID NCT07454837

Disease control Sponsor: Mirum Pharmaceuticals, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 6 times

Summary

This study tests whether switching from the current drug bulevirtide to a new drug called brelovitug can better control chronic hepatitis Delta. About 120 adults who have been on bulevirtide for at least 6 months will take brelovitug for 24 weeks. The main goal is to see if the virus becomes undetectable in the blood.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 120 people

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

Started

Feb 2026

Expected to finish

Mar 2029

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 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: 1. Willing and able to provide written informed consent. 2. Male or female, ≥18 years of age at Screening. 3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study. 4. Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening. 5. HDV RNA ≥100 IU/mL at Screening. Exclusion Criteria: 1. Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding). 2. Known history of immune-complex disease. 3. Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV). 4. Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis). 5. History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.

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Conditions

The condition(s) this trial relates to.

hepatitis D virus infection Hepatitis D, Chronic

As listed by the trial registrant

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

Chronic hepatitis D

How to take part

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

  1. The places running it

    44 sites in 8 countries. 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

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

  • Barts Health NHS Trust

    RECRUITING

    London, E12AT, United Kingdom

  • CHU Grenoble Alpes Hopital Nord Michallon

    RECRUITING

    Grenoble, 38700, France

  • CHU Limoges

    RECRUITING

    Limoges, 87000, France

  • CHU Toulouse Hospital Rangueil, Toulouse

    RECRUITING

    Toulouse, 31400, France

  • CHU de Bordeaux

    RECRUITING

    Bordeaux, 33076, France

  • Cardiff and Vale University Health Board

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • Castle Hill Hospital

    RECRUITING

    Cottingham, Yorkshire, HU165JQ, United Kingdom

  • Centre Hospitalier Intercommunal De Creteil

    RECRUITING

    Créteil, 94000, France

  • Centre Hospitalier de Versailles

    RECRUITING

    Versailles, 78150, France

  • Centrul Medical Unirea S.R.L

    RECRUITING

    Iași, Lasi, 700023, Romania

  • Chelsea and Westminster Hospital

    RECRUITING

    London, SW109NH, United Kingdom

  • Chu de Rennes Hopital Pontchaillou

    RECRUITING

    Rennes, 35000, France

  • Clermont-Ferrand University Hospital

    RECRUITING

    Clermont-Ferrand, 63100, France

  • Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes

    RECRUITING

    Bucharest, 030303, Romania

  • Fakultni Nemocnice Brno (University Hospital Brno)

    RECRUITING

    Brno, 62500, Czechia

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fundeni Clinical Institute

    RECRUITING

    Bucharest, 022328, Romania

  • Goethe University Frankfurt

    RECRUITING

    Frankfurt, 60323, Germany

  • Henri Mondor University Hospital (APHP)

    RECRUITING

    Créteil, 94000, France

  • Hopital Saint-Eloi

    RECRUITING

    Montpellier, 34090, France

  • Hospital Beaujon

    RECRUITING

    Clichy, 92110, France

  • Hospital Clinic I Provincial De Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital De La Croix Rousse

    RECRUITING

    Lyon, 69004, France

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • ICH Study Center GmbH & Co KG

    RECRUITING

    Hamburg, 20146, Germany

  • Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)

    RECRUITING

    Prague, 14021, Czechia

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Klin Med Ltd. (KLIN MED s.r.o.)

    RECRUITING

    Prague, 12000, Czechia

  • Manchester University Nhs Foundation Trust

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Marques De Valdecilla University Hospital

    RECRUITING

    Cantoria, 39008, Spain

  • Medical University of Graz

    RECRUITING

    Graz, 8010, Austria

  • Medical University of Vienna

    RECRUITING

    Vienna, 1090, Austria

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • Medizinische Universitat Innsbruck

    RECRUITING

    Innsbruck, A-6020, Austria

  • National Institute Of Infectious Diseases Prof. Dr. Matei Bals

    RECRUITING

    Bucharest, 021105, Romania

  • National Institute Of Infectious Diseases Prof. Dr. Matei Bals

    RECRUITING

    Bucharest, 21105, Romania

  • Pitie-Salpetriere Hosptial

    RECRUITING

    Paris, 75013, France

  • Spitalul Clinic de Boli Infectioase Constanta

    RECRUITING

    Constanța, 900709, Romania

  • Universitatsmedizin Rostock

    RECRUITING

    Rostock, 18057, Germany

  • University Hospital St. Polten- Lilenfeld

    RECRUITING

    Lilienfeld, 3100, Austria

  • University Hospital of Dusseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • Vall d'Hebron Hospital

    RECRUITING

    Barcelona, 08035, Spain

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