Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

September 8, 2026 updated by: Mirum Pharmaceuticals, Inc.

A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Austria
      • Graz, Austria, 8010
        • Recruiting
        • Medical University of Graz
      • Innsbruck, Austria, A-6020
        • Recruiting
        • Medizinische Universität Innsbruck
      • Lilienfeld, Austria, 3100
        • Recruiting
        • University Hospital St. Polten- Lilenfeld
      • Vienna, Austria, 1090
        • Recruiting
        • Medical University of Vienna
  • Czechia
      • Brno, Czechia, 62500
        • Recruiting
        • Fakultni Nemocnice Brno (University Hospital Brno)
      • Prague, Czechia, 12000
        • Recruiting
        • Klin Med Ltd. (KLIN MED s.r.o.)
      • Prague, Czechia, 14021
        • Recruiting
        • Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)
  • France
      • Bordeaux, France, 33076
        • Recruiting
        • CHU de Bordeaux
      • Clermont-Ferrand, France, 63100
        • Recruiting
        • Clermont-Ferrand University Hospital
      • Clichy, France, 92110
        • Recruiting
        • Hospital Beaujon
      • Créteil, France, 94000
        • Recruiting
        • Centre Hospitalier Intercommunal de Créteil
      • Créteil, France, 94000
        • Recruiting
        • Henri Mondor University Hospital (APHP)
      • Grenoble, France, 38700
        • Recruiting
        • CHU Grenoble Alpes Hopital Nord Michallon
      • Limoges, France, 87000
        • Recruiting
        • CHU Limoges
      • Lyon, France, 69004
        • Recruiting
        • Hospital De La Croix Rousse
      • Montpellier, France, 34090
        • Recruiting
        • Hôpital Saint-Eloi
      • Paris, France, 75013
        • Recruiting
        • Pitie-Salpetriere Hosptial
      • Rennes, France, 35000
        • Recruiting
        • Chu de Rennes Hopital Pontchaillou
      • Toulouse, France, 31400
        • Recruiting
        • CHU Toulouse Hospital Rangueil, Toulouse
      • Versailles, France, 78150
        • Recruiting
        • Centre Hospitalier De Versailles
  • Germany
      • Düsseldorf, Germany, 40225
        • Recruiting
        • University Hospital of Dusseldorf
      • Frankfurt, Germany, 60323
        • Recruiting
        • Goethe University Frankfurt
      • Hamburg, Germany, 20146
        • Recruiting
        • ICH Study Center GmbH & Co KG
      • Hanover, Germany, 30625
        • Recruiting
        • Medizinische Hochschule Hannover
      • Rostock, Germany, 18057
        • Recruiting
        • Universitätsmedizin Rostock
  • Italy
      • Bergamo, Italy, 24127
        • Recruiting
        • Azienda Socio Sanitaria Territoriale Papa Giovanni xxiii
      • Milan, Italy, 20122
        • Recruiting
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
      • Milan, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Fundeni Clinical Institute
      • Bucharest, Romania, 030303
        • Recruiting
        • Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes
      • Bucharest, Romania, 21105
        • Recruiting
        • National Institute Of Infectious Diseases Prof. Dr. Matei Bals
      • Bucharest, Romania, 021105
        • Recruiting
        • National Institute Of Infectious Diseases Prof. Dr. Matei Bals
      • Constanța, Romania, 900709
        • Recruiting
        • Spitalul Clinic de Boli Infectioase Constanta
    • Lasi
      • Iași, Lasi, Romania, 700023
        • Recruiting
        • Centrul Medical Unirea S.R.L
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Hospital
      • Cantoria, Spain, 39008
        • Recruiting
        • Marques De Valdecilla University Hospital
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
  • United Kingdom
      • Cardiff, United Kingdom, CF14 4XW
        • Recruiting
        • Cardiff and Vale University Health Board
      • London, United Kingdom, SE5 9RS
        • Recruiting
        • King's College Hospital NHS Foundation Trust
      • London, United Kingdom, SW109NH
        • Recruiting
        • Chelsea and Westminster Hospital
      • London, United Kingdom, E12AT
        • Recruiting
        • Barts Health NHS Trust
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester University NHS Foundation Trust
    • Yorkshire
      • Cottingham, Yorkshire, United Kingdom, HU165JQ
        • Recruiting
        • Castle Hill Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Immediate Switch to Brelovitug
Participants will switch to brelovitug 300 mg once weekly for 96 weeks.
Drug: Brelovitug (BJT-778)
Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.
Other Names:
  • BJT-778
Experimental: Delayed Switch from Bulevirtide to Brelovitug
Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks.
Drug: Bulevirtide
Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.
Other Names:
  • Hepcludex
  • BJT-778

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])
Time Frame: Week 24
The proportion of participants with undetectable HDV RNA (<LLOQ, TND) at Week 24
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: Up to Week 96
Incidence and severity of treatment-emergent adverse events (TEAEs) during brelovitug and bulevirtide treatment periods.
Up to Week 96
Proportion of participants who permanently discontinue treatment due to an adverse event
Time Frame: Up to Week 96
Proportion of participants who permanently discontinue study treatment because of an adverse event.
Up to Week 96
Change from baseline in serum total bile salts
Time Frame: Up to Week 96
Mean change from baseline in serum total bile salt levels.
Up to Week 96
Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)
Time Frame: Up to Week 96
Proportion of participants with virologic response at Weeks 24, 48, 72, and 96.
Up to Week 96
Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.
Time Frame: Up to Week 96
Up to Week 96
Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.
Time Frame: Up to Week 96
Up to Week 96
Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)
Time Frame: Up to Week 96
Proportion of participants with normal ALT and virologic response at Weeks 24, 48, 72, and 96.
Up to Week 96
Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.
Time Frame: Up to Week 96
Up to Week 96
Change from baseline in HDV RNA
Time Frame: Up to Week 96
Change from baseline in HDV RNA levels over time during treatment.
Up to Week 96
Change from baseline in ALT levels
Time Frame: Up to Week 96
Change from baseline ALT levels over time during treatment.
Up to Week 96
Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up
Time Frame: Up to Week 48
Up to Week 48
Change from baseline in liver stiffness
Time Frame: Up to Week 96
Change from baseline in liver stiffness as determined by transient elastography at weeks 24, 48 and 96
Up to Week 96
Change from baseline in MELD score
Time Frame: Up to Week 96
Change from baseline in MELD score at Weeks 24, 48, and 96 in participants with cirrhosis
Up to Week 96
Proportion of participants with clinical disease progression from baseline
Time Frame: Up to Week 96
Proportion of participants with clinical disease progression from baseline in HDV-associated liver disease at Weeks 24, 48, and 96.
Up to Week 96
Proportion of participants achieving HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.
Time Frame: Up to Week 96
Up to Week 96
Proportion of participants achieving normal ALT with HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96
Time Frame: Up to Week 96
Up to Week 96
Change from baseline in APRI
Time Frame: Up to Week 96
Change from baseline in APRI at weeks 24, 48, and 96
Up to Week 96
Change in baseline in CTP score
Time Frame: Up to Week 96
Change from baseline in CTP score at Weeks 24, 48, and 96 in participants with cirrhosis
Up to Week 96

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mirum Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BJT-778-303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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