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Chronic Hepatitis D InfectionPhase 3NCT07200908

A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

A Phase 3 study testing Brelovitug 300 mg and Bulevirtide 2 mg and Brelovitug - 300 mg in people with Chronic Hepatitis D Infection, run by Mirum Pharmaceuticals, Inc. at 57 sites in 12 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Chronic Hepatitis D Infection
What is being tested?
Brelovitug 300 mg and Bulevirtide 2 mg and Brelovitug - 300 mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
172 participants
Where
57 sitesin 12 countries
Study dates
27 Aug 2025to 30 Sep 2029
Phase
Phase 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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Willing and able to provide written informed consent
  • Chronic HDV infection
  • HDV RNA >500 IU/mL at Screening
  • ALT >ULN at Screening
  • Willing to take or already taking HBV neucleos(t)ide therapy.

Who cannot join

  • Pregnant or nursing females
  • Unwilling to comply with contraception requirements during the study
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
  • Solid organ or bone marrow transplantation
  • 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.

Trial locations and contacts

57 sites in 12 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials Clinical Trials Mirum contact

+16506674085

clinicaltrials@mirumpharma.com

Mirum Pharmaceuticals, Inc., Clinical Trials contact

57 sites in 12 countries

France13 sites, 13 recruiting

  • Hôpital Estaing

    Clermont-Ferrand, 63000

    Recruiting

  • Hôpital Beaujon

    Clichy, 92110

    Recruiting

  • University Hospital Henri Mondor - APHP

    Créteil, 94000

    Recruiting

  • CHU Grenoble Alpes Hopital Nord Michallon

    La Tronche, 38700

    Recruiting

  • Centre Hospitalier de Versailles _ Hopital Andre Magnot

    Le Chesnay, 78157

    Recruiting

  • Lille Regional University Hospital Centre

    Lille, 59000

    Recruiting

  • University Hospital Limoges

    Limoges, 87042

    Recruiting

  • Hôpital de la Croix-Rousse

    Lyon, 69004

    Recruiting

  • Hôpital Pitié Salpêtrière

    Paris, 75013

    Recruiting

  • Hopital Cochin

    Paris, 75014

    Recruiting

  • CHU de Bordeaux - Hopital Haut-Leveque

    Pessac, 33604

    Recruiting

  • Centre Hospitalier Universitaire De Rennes

    Rennes, 35000

    Recruiting

  • Hôpital Rangueil

    Toulouse, 31059

    Recruiting

Other trials in France

Italy7 sites, 7 recruiting

  • ASST Papa Giovanni XXIII

    Bergamo, 24127

    Recruiting

  • Humanitas Research Hospital

    Milan, 20089

    Recruiting

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

    Recruiting

  • University of Parma

    Parma, 43126

    Recruiting

  • AOU Pisana - Cisanello

    Pisa, 56126

    Recruiting

  • National Institute of Infectious Diseases Lazzaro Spallanzani

    Roma, 00149

    Recruiting

Other trials in Italy

Spain7 sites, 7 recruiting

  • Hospital Universitario Torrecardenas

    Almería, Almeria, 04009

    Recruiting

  • Hospital Universitari Vall D Hebron

    Barcelona, Barcelona, 08035

    Recruiting

  • Hospital Clinic Provincial De Barcelona

    Barcelona, 08036

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    Recruiting

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

    Recruiting

  • Hospital Universitario Álvaro Cunqueiro

    Vigo, 36312

    Recruiting

Other trials in Spain

Romania6 sites, 6 recruiting

  • National Institute Of Infectious Diseases

    Bucharest, Bucharest, 021105

    Recruiting

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

    Bucharest, Bucharest, 030303

    Recruiting

  • National Institute of Infectious Diseases Prof Dr Matei Bals

    Bucharest, 021105

    Recruiting

  • Fundeni Clinical Institute

    Bucharest, 022328

    Recruiting

  • Spitalul Clinic de Boli Infectioase Constanta

    Constanța, 900709

    Recruiting

  • Centrul Medical Unirea S.R.L

    Iași, Lasi, 700023

    Recruiting

Other trials in Romania

United Kingdom6 sites, 6 recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, Birmingham, B15 2GW

    Recruiting

  • Hull University Teaching Hospitals

    Cottingham, HU16 5JQ

    Recruiting

  • Chelsea and Westminster Hospital NHS Foundation Trust

    London, London, SW10 9NH

    Recruiting

  • Barts Health NHS Trust

    London, E12ES

    Recruiting

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

    Recruiting

  • North Manchester General Hospital

    Manchester, Manchester, M8 5RB

    Recruiting

Other trials in United Kingdom

Czechia5 sites, 5 recruiting

  • Fakultni Nemocnice Brno

    Brno, Brno, 62500

    Recruiting

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 03

    Recruiting

  • Krajská nemocnice Liberec, a.s.

    Liberec, Liberec, 460 01

    Recruiting

  • Institute For Clinical And Experimental Medicine

    Prague, Prague, 140 00

    Recruiting

  • Klin Med s.r.o.

    Prague, Prague, 2 120 00

    Recruiting

Other trials in Czechia

Germany4 sites, 4 recruiting

  • Universitätsklinikum Düsseldorf

    Düsseldorf, 40225

    Recruiting

  • Goethe University Frankfurt

    Frankfurt, Frankfurt, 60590

    Recruiting

  • Medizinische Hochschule Hannover

    Hanover, 30625

    Recruiting

  • Rostock University Medical Center

    Rostock, Rostock, 18057

    Recruiting

Other trials in Germany

Switzerland3 sites, 3 recruiting

  • Hôpitaux Universitaires

    Geneva, Canton of Geneva, 1205

    Recruiting

  • HOCH Health Ostschweiz

    Sankt Gallen, St.Gallen, 95 9007

    Recruiting

  • Universitätsspital Zürich

    Zurich, 8091

    Recruiting

Other trials in Switzerland

Austria2 sites, 2 recruiting

  • Medical University of Graz

    Graz, 8036

    Recruiting

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

    Recruiting

Other trials in Austria

Uzbekistan2 sites, 2 recruiting

  • Republican Specialized Scientific and Practical Medical Center of Epidemiology, Microbiology, Infectious and Parasitic Diseases

    Fergana, 150100

    Recruiting

  • Research Institute of Virology of the Republic of Uzbekistan

    Tashkent, 100194

    Recruiting

Other trials in Uzbekistan

Pakistan1 site, 1 recruiting

  • Aga Khan University, Aga Khan Hospital and Medical College Foundation

    Karachi, 0709421-7

    Recruiting

Other trials in Pakistan

Sweden1 site, 1 recruiting

  • Karolinska University Hospital

    Huddinge, 14186

    Recruiting

Other trials in Sweden

About this study

Official title: A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.

Read the detailed description

Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms:

Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.

Arm 2: Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.

Being tested
Brelovitug 300 mg, Bulevirtide 2 mg and Brelovitug - 300 mg
Keywords
Hepatitis Delta virus, HDV, Hepatitis D infection; Hepatitis D virus
Medical subject headings
Hepatitis D

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brelovitug 300 mgDrug

    Also called BJT-778, BTG

    Route of administration- Subcutaneous Injection

  • Bulevirtide 2 mg and Brelovitug - 300 mgDrug

    Also called Hepcludex

    Route of Administration- Subcutaneous Injection

Study groups in NCT07200908
Study groupRoleWhat they receive
BrelovitugExperimentalParticipants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Receives: Drug: Brelovitug 300 mg
Bulevirtide for 48 weeks followed by brelovitug for 48 weeksActive comparatorParticipants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.
Receives: Drug: Bulevirtide 2 mg and Brelovitug - 300 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with a composite endpoint of virologic response and ALT normalization

    The composite endpoint is defined as virologic response (undetectable HDV RNA, < the lower limit of quantification [LLOQ], target not detected [TND]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal [ULN])

    Measured: Week 48

Secondary outcomes (17)

  1. Percentage of participants with treatment-emergent adverse events (TEAEs)

    An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

    Measured: Up to 96 weeks

  2. Percentage of participants who discontinue treatment due to an adverse event (AE)

    An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

    Measured: Up to 96 weeks

  3. Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

    Measured: Up 96 Weeks

  4. Percentage of participants with HDV RNA <LLOQ

    Measured: Up to 96 Weeks

  5. Percentage of participants with HDV RNA <LLOQ, TND

    Measured: Up to 96 Weeks

  6. Percentage of participants with ALT normalization

    ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN

    Measured: Up to 96 Weeks

  7. Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND.

    Measured: Up to 96 Weeks

  8. Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ.

    Measured: Up to 96 Weeks

  9. Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND

    The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA <LLOQ, TND.

    Measured: Up to 96 Weeks

  10. Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)

    Measured: Up to 96 Weeks

  11. Change from baseline in APRI (AST-to-platelet ratio index)

    Measured: Up to 96 Weeks

  12. Change from baseline in CTP score in participants with cirrhosis

    Measured: Up to 96 Weeks

  13. Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis

    Measured: Up to 96 Weeks

  14. Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease.

    Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC).

    Measured: Up to 96 Weeks

  15. Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.

    Measured: Post-Treatment Weeks 24 and 48

  16. Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Chronic Liver Disease Questionnaire-HBV (CLDQ-HBV)

    Measured: Up to 96 Weeks

  17. Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Measured: Up to 96 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2025
  2. Study start27 Aug 2025
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Sep 2029 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
172 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07200908
Sponsor's protocol ID
BJT-778-302
Other IDs
2024-517167-23-00
Status last verified
Oct 2026
First submitted
16 Sep 2025
Last updated
8 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brelovitug 300 mg and Bulevirtide 2 mg and Brelovitug - 300 mg in people with Chronic Hepatitis D Infection, run by Mirum Pharmaceuticals, Inc. at 57 sites in 12 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 7 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 8 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 57 sites in France, Italy, Spain, Romania, United Kingdom and 7 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 phase mean?

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 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?

Percentage of participants with a composite endpoint of virologic response and ALT normalization (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07200908.

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 8 Oct 2026.

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