Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New hope for hepatitis delta: phase 3 trial launches

NCT ID NCT07200908

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Updated 2 times

Summary

This phase 3 trial compares a new drug, brelovitug, to an existing treatment (bulevirtide) for chronic hepatitis delta, a serious liver infection. About 172 adults with the infection will receive either drug to see which better controls the virus and normalizes liver enzymes. The goal is to find a more effective long-term treatment option.

What this could mean

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

Active substance
brelovitug (also called BJT-778)
What this could lead to
If it works, this could offer a more effective long-term treatment option for people with chronic hepatitis delta, potentially improving liver health and reducing the virus.
What could go wrong
This is a phase 3 trial, but it's still early to know if brelovitug is truly better or safer than the existing drug. Side effects are possible, and the study is relatively small (172 people).

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 172 people

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

Started

Aug 2025

Expected to finish

Sep 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 to 99 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.

Key Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV neucleos(t)ide therapy. Key Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma. Note - Other protocol-defined Inclusion/Exclusion criteria apply.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic hepatitis D infection are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

hepatitis D virus infection

As listed by the trial registrant

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

Chronic hepatitis D infection

How to take part

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

  1. The places running it

    53 sites in 11 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

  • AOU Pisana - Cisanello

    RECRUITING

    Pisa, 56126, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    RECRUITING

    Milan, 20162, Italy

  • ASST Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

  • Barts Health NHS Trust

    RECRUITING

    London, E12ES, United Kingdom

  • CHU Grenoble Alpes Hopital Nord Michallon

    RECRUITING

    La Tronche, 38700, France

  • CHU de Bordeaux - Hopital Haut-Leveque

    RECRUITING

    Pessac, 33604, France

  • Centre Hospitalier Universitaire De Rennes

    RECRUITING

    Rennes, 35000, France

  • Centre Hospitalier de Versailles _ Hopital Andre Magnot

    RECRUITING

    Le Chesnay, 78157, France

  • Centrul Medical Unirea S.R.L

    RECRUITING

    Iași, Lasi, 700023, Romania

  • Chelsea and Westminster Hospital NHS Foundation Trust

    RECRUITING

    London, London, SW10 9NH, United Kingdom

  • Fakultni Nemocnice Brno

    RECRUITING

    Brno, Brno, 62500, Czechia

  • Fakultni Nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, Hradec Králové, 500 03, Czechia

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fundeni Clinical Institute

    RECRUITING

    Bucharest, 022328, Romania

  • Goethe University Frankfurt

    RECRUITING

    Frankfurt, Frankfurt, 60590, Germany

  • HOCH Health Ostschweiz

    RECRUITING

    Sankt Gallen, St.Gallen, 95 9007, Switzerland

  • Hopital Cochin

    RECRUITING

    Paris, 75014, France

  • Hospital Clinic Provincial De Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital Universitari Vall D Hebron

    RECRUITING

    Barcelona, Barcelona, 08035, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, 39008, Spain

  • Hospital Universitario Ramón y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Torrecardenas

    RECRUITING

    Almería, Almeria, 04009, Spain

  • Hospital Universitario Virgen de la Victoria

    RECRUITING

    Málaga, 29010, Spain

  • Hospital Universitario Álvaro Cunqueiro

    RECRUITING

    Vigo, 36312, Spain

  • Hull University Teaching Hospitals

    RECRUITING

    Cottingham, HU16 5JQ, United Kingdom

  • Hôpital Beaujon

    RECRUITING

    Clichy, 92110, France

  • Hôpital Estaing

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Hôpital Pitié Salpêtrière

    RECRUITING

    Paris, 75013, France

  • Hôpital Rangueil

    RECRUITING

    Toulouse, 31059, France

  • Hôpital de la Croix-Rousse

    RECRUITING

    Lyon, 69004, France

  • Hôpitaux Universitaires

    RECRUITING

    Geneva, Canton of Geneva, 1205, Switzerland

  • Institute For Clinical And Experimental Medicine

    RECRUITING

    Prague, Prague, 140 00, Czechia

  • Karolinska University Hospital

    RECRUITING

    Huddinge, 14186, Sweden

  • King's College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Klin Med s.r.o.

    RECRUITING

    Prague, Prague, 2 120 00, Czechia

  • Krajská nemocnice Liberec, a.s.

    RECRUITING

    Liberec, Liberec, 460 01, Czechia

  • Lille Regional University Hospital Centre

    RECRUITING

    Lille, 59000, France

  • Medical University of Graz

    RECRUITING

    Graz, 8036, Austria

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • National Institute Of Infectious Diseases

    RECRUITING

    Bucharest, Bucharest, 021105, Romania

  • National Institute of Infectious Diseases Lazzaro Spallanzani

    RECRUITING

    Roma, 00149, Italy

  • National Institute of Infectious Diseases Prof Dr Matei Bals

    RECRUITING

    Bucharest, 021105, Romania

  • North Manchester General Hospital

    RECRUITING

    Manchester, Manchester, M8 5RB, United Kingdom

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Birmingham, Birmingham, B15 2GW, United Kingdom

  • Research Institute of Virology of the Republic of Uzbekistan

    RECRUITING

    Tashkent, 100194, Uzbekistan

  • Rostock University Medical Center

    RECRUITING

    Rostock, Rostock, 18057, Germany

  • Spitalul Clinic De Boli Infectioase Si Tropicale Dr. Victor Babes

    RECRUITING

    Bucharest, Bucharest, 030303, Romania

  • Spitalul Clinic de Boli Infectioase Constanta

    RECRUITING

    Constanța, 900709, Romania

  • University Hospital Henri Mondor - APHP

    RECRUITING

    Créteil, 94000, France

  • University Hospital Limoges

    RECRUITING

    Limoges, 87042, France

  • Universitätsklinikum Düsseldorf

    RECRUITING

    Düsseldorf, 40225, Germany

  • Universitätsklinikum St. Pölten

    RECRUITING

    Sankt Pölten, 3100, Austria

  • Universitätsspital Zürich

    RECRUITING

    Zurich, 8091, Switzerland

More trials for these conditions

Other studies related to the condition(s) this trial covers.