Chronic Hepatitis DPhase 2/3NCT07454837
Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide
A Phase 2/3 study testing Brelovitug (BJT-778) and Bulevirtide in people with Chronic Hepatitis D, run by Mirum Pharmaceuticals, Inc. at 46 sites in 8 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis D
- What is being tested?
- Brelovitug (BJT-778) and Bulevirtide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 46 sitesin 8 countries
- Study dates
- 26 Feb 2026to 30 Mar 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent.
- Male or female, ≥18 years of age at Screening.
- Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
- Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
- HDV RNA ≥100 IU/mL at Screening.
Who cannot join
- Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).
- Known history of immune-complex disease.
- Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).
- History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.
Trial locations and contacts
46 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
Medinfo Mirum contact
46 sites in 8 countries
France14 sites, 14 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux, 33076
- Recruiting
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63100
- Recruiting
Hospital Beaujon
Clichy, 92110
- Recruiting
Centre Hospitalier Intercommunal De Creteil
Créteil, 94000
- Recruiting
Henri Mondor University Hospital (APHP)
Créteil, 94000
- Recruiting
CHU Grenoble Alpes Hopital Nord Michallon
Grenoble, 38700
- Recruiting
CHU de Lille
Lille, 59037
- Recruiting
CHU Limoges
Limoges, 87000
- Recruiting
Hospital De La Croix Rousse
Lyon, 69004
- Recruiting
Hopital Saint-Eloi
Montpellier, 34090
- Recruiting
Pitie-Salpetriere Hosptial
Paris, 75013
- Recruiting
Chu de Rennes Hopital Pontchaillou
Rennes, 35000
- Recruiting
CHU Toulouse Hospital Rangueil, Toulouse
Toulouse, 31400
- Recruiting
Centre Hospitalier de Versailles
Versailles, 78150
Romania6 sites, 6 recruiting
- Recruiting
National Institute Of Infectious Diseases Prof. Dr. Matei Bals
Bucharest, 021105
- Recruiting
Fundeni Clinical Institute
Bucharest, 022328
- Recruiting
Clinical Hospital for Infectious and Tropical Diseases Dr. Victor Babes
Bucharest, 030303
- Recruiting
National Institute Of Infectious Diseases Prof. Dr. Matei Bals
Bucharest, 21105
- Recruiting
Spitalul Clinic de Boli Infectioase Constanta
Constanța, 900709
- Recruiting
Centrul Medical Unirea S.R.L
Iași, Lasi, 700023
United Kingdom6 sites, 6 recruiting
- Recruiting
Cardiff and Vale University Health Board
Cardiff, CF14 4XW
- Recruiting
Castle Hill Hospital
Cottingham, Yorkshire, HU165JQ
- Recruiting
Barts Health NHS Trust
London, E12AT
- Recruiting
King's College Hospital NHS Foundation Trust
London, SE5 9RS
- Recruiting
Chelsea and Westminster Hospital
London, SW109NH
- Recruiting
Manchester University Nhs Foundation Trust
Manchester, M13 9WL
Germany5 sites, 5 recruiting
- Recruiting
University Hospital of Dusseldorf
Düsseldorf, 40225
- Recruiting
Goethe University Frankfurt
Frankfurt, 60323
- Recruiting
ICH Study Center GmbH & Co KG
Hamburg, 20146
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
- Recruiting
Universitatsmedizin Rostock
Rostock, 18057
Austria4 sites, 4 recruiting
- Recruiting
Medical University of Graz
Graz, 8010
- Recruiting
Medizinische Universitat Innsbruck
Innsbruck, A-6020
- Recruiting
University Hospital St. Polten- Lilenfeld
Lilienfeld, 3100
- Recruiting
Medical University of Vienna
Vienna, 1090
Italy4 sites, 4 recruiting
- Recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
- Recruiting
Humanitas Clinical and Research Center & Humanitas University
Milan, 20089
- Recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Spain4 sites, 4 recruiting
- Recruiting
Vall d'Hebron Hospital
Barcelona, 08035
- Recruiting
Hospital Clinic I Provincial De Barcelona
Barcelona, 08036
- Recruiting
Marques De Valdecilla University Hospital
Cantoria, 39008
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
Czechia3 sites, 3 recruiting
- Recruiting
Fakultni Nemocnice Brno (University Hospital Brno)
Brno, 62500
- Recruiting
Klin Med Ltd. (KLIN MED s.r.o.)
Prague, 12000
- Recruiting
Institut klinicke a experimentalni mediciny- IKEM (Institute for Clinical and Experimental Medicine)
Prague, 14021
About this study
Official title: 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).
Read the 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).
- Conditions
- Chronic Hepatitis D
- Being tested
- Brelovitug (BJT-778), Bulevirtide
- Medical subject headings
- Hepatitis D, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brelovitug (BJT-778)Drug
Also called BJT-778
Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.
BulevirtideDrug
Also called BJT-778, Hepcludex
Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Switch to Brelovitug | Experimental | Participants will switch to brelovitug 300 mg once weekly for 96 weeks. Receives: Drug: Brelovitug (BJT-778) |
| Delayed Switch from Bulevirtide to Brelovitug | Experimental | Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks. Receives: Drug: Bulevirtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])
The proportion of participants with undetectable HDV RNA (<LLOQ, TND) at Week 24
Measured: Week 24
Secondary outcomes (18)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs) during brelovitug and bulevirtide treatment periods.
Measured: Up to Week 96
Proportion of participants who permanently discontinue treatment due to an adverse event
Proportion of participants who permanently discontinue study treatment because of an adverse event.
Measured: Up to Week 96
Change from baseline in serum total bile salts
Mean change from baseline in serum total bile salt levels.
Measured: Up to Week 96
Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)
Proportion of participants with virologic response at Weeks 24, 48, 72, and 96.
Measured: Up to Week 96
Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.
Measured: Up to Week 96
Proportion of participants achieving HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.
Measured: Up to Week 96
Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.
Measured: 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)
Proportion of participants with normal ALT and virologic response at Weeks 24, 48, 72, and 96.
Measured: Up to Week 96
Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.
Measured: Up to Week 96
Proportion of participants achieving normal ALT with HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96
Measured: Up to Week 96
Change from baseline in HDV RNA
Change from baseline in HDV RNA levels over time during treatment.
Measured: Up to Week 96
Change from baseline in ALT levels
Change from baseline ALT levels over time during treatment.
Measured: Up to Week 96
Change from baseline in liver stiffness
Change from baseline in liver stiffness as determined by transient elastography at weeks 24, 48 and 96
Measured: Up to Week 96
Change from baseline in APRI
Change from baseline in APRI at weeks 24, 48, and 96
Measured: Up to Week 96
Change in baseline in CTP score
Change from baseline in CTP score at Weeks 24, 48, and 96 in participants with cirrhosis
Measured: Up to Week 96
Change from baseline in MELD score
Change from baseline in MELD score at Weeks 24, 48, and 96 in participants with cirrhosis
Measured: Up to Week 96
Proportion of participants with clinical disease progression from baseline
Proportion of participants with clinical disease progression from baseline in HDV-associated liver disease at Weeks 24, 48, and 96.
Measured: Up to Week 96
Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up
Measured: Up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start26 Feb 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis DStudies of the same condition, open and under way.
- More trials run by Mirum Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454837
- Sponsor's protocol ID
- BJT-778-303
- Status last verified
- Oct 2026
- First submitted
- 2 Mar 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07454837
- Acronym / sponsor ID
- BJT-778-303
- Conditions
- Chronic Hepatitis D
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Mirum Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Switch to Brelovitug | Experimental | Drug: Brelovitug (BJT-778)Participants will switch to brelovitug 300 mg once weekly for 96 weeks. |
| Delayed Switch from Bulevirtide to Brelovitug | Experimental | Drug: BulevirtideParticipants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Willing and able to provide written informed consent.
- Male or female, ≥18 years of age at Screening.
- Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.
- Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.
- HDV RNA ≥100 IU/mL at Screening.
Key exclusion criteria (5 listed)
- Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).
- Known history of immune-complex disease.
- Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).
- History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brelovitug (BJT-778)Also: BJT-778Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks. | Drug | Immediate Switch to Brelovitug |
| BulevirtideAlso: BJT-778, HepcludexBulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide. | Drug | Delayed Switch from Bulevirtide to Brelovitug |
Primary outcome
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
18 secondary outcomes
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to Week 96
Proportion of participants who permanently discontinue treatment due to an adverse event
Time frame: Up to Week 96
Change from baseline in serum total bile salts
Time frame: 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 achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.
Time frame: 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
Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.
Time frame: 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 achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.
Time frame: 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
Change from baseline in HDV RNA
Time frame: Up to Week 96
Change from baseline in ALT levels
Time frame: Up to Week 96
Change from baseline in liver stiffness
Time frame: Up to Week 96
Change from baseline in APRI
Time frame: Up to Week 96
Change in baseline in CTP score
Time frame: Up to Week 96
Change from baseline in MELD score
Time frame: Up to Week 96
Proportion of participants with clinical disease progression from baseline
Time frame: Up to Week 96
Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up
Time frame: Up to Week 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Medinfo Mirum contact
46 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Brelovitug (BJT-778) and Bulevirtide in people with Chronic Hepatitis D, run by Mirum Pharmaceuticals, Inc. at 46 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in France, Romania, United Kingdom, Germany, Austria and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Mirum (+16506674085, clinicaltrials@mirumpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND]) (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.