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.
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
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.
Mirum Pharmaceuticals, Inc., Clinical Trials contact
57 sites in 12 countries
France13 sites, 13 recruiting
- 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
Italy7 sites, 7 recruiting
- 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
Spain7 sites, 7 recruiting
- 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
Romania6 sites, 6 recruiting
- 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
United Kingdom6 sites, 6 recruiting
- 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
Czechia5 sites, 5 recruiting
- 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
Germany4 sites, 4 recruiting
- 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
Switzerland3 sites, 3 recruiting
- Recruiting
Hôpitaux Universitaires
Geneva, Canton of Geneva, 1205
- Recruiting
HOCH Health Ostschweiz
Sankt Gallen, St.Gallen, 95 9007
- Recruiting
Universitätsspital Zürich
Zurich, 8091
Austria2 sites, 2 recruiting
- Recruiting
Medical University of Graz
Graz, 8036
- Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, 3100
Uzbekistan2 sites, 2 recruiting
- 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
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University, Aga Khan Hospital and Medical College Foundation
Karachi, 0709421-7
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital
Huddinge, 14186
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.
- Conditions
- Chronic Hepatitis D Infection
- 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 group | Role | What they receive |
|---|---|---|
| Brelovitug | Experimental | Participants 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 weeks | Active comparator | 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. 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.
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)
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
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
Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND
Measured: Up 96 Weeks
Percentage of participants with HDV RNA <LLOQ
Measured: Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ, TND
Measured: Up to 96 Weeks
Percentage of participants with ALT normalization
ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN
Measured: Up to 96 Weeks
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
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
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
Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)
Measured: Up to 96 Weeks
Change from baseline in APRI (AST-to-platelet ratio index)
Measured: Up to 96 Weeks
Change from baseline in CTP score in participants with cirrhosis
Measured: Up to 96 Weeks
Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis
Measured: Up to 96 Weeks
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
Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.
Measured: Post-Treatment Weeks 24 and 48
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
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.
- First posted1 Oct 2025
- Study start27 Aug 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 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 D InfectionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 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
- 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