Chronic Hepatitis D InfectionPhase 3NCT07298330
A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
A Phase 3 study testing Brelovitug 300 mg, Brelovitug 900 mg and Delayed Treatment with Brelovitug 300mg in people with Chronic Hepatitis D Infection, run by Mirum Pharmaceuticals, Inc. at 27 sites in 10 countries.
Trial summary
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. 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, Brelovitug 900 mg and Delayed Treatment with Brelovitug 300mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 27 sitesin 10 countries
- Study dates
- 14 Jan 2026to Jan 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 nucleos(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 metabolic dysfunction-associated steatohepatitis (MASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
- Note - Other protocol-defined Inclusion/Exclusion criteria apply.
Trial locations and contacts
27 sites in 10 countries.
27 sites in 10 countries
United States8 sites
Cleveland Clinic
Cleveland, Ohio, 44195
University of California, Davis
Davis, California, 95616
Denver Health Medical Center
Denver, Colorado, 80204
Alliance Clinical, Las Vegas
Las Vegas, Nevada, 89019
Prime Clinical Research Inc
Mansfield, Texas, 76063
Kaiser Permanente Medical Center
Sacramento, California, 95661
University of Utah
Salt Lake City, Utah, 84132
Quest Clinical Research
San Francisco, California, 94115
Georgia4 sites
Hospital Service LTD
Kutaisi, 4608
Diakori LLC
Tbilisi, 0159
JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0159
LTD Academician Vakhtang Bochorishvili Clinic
Tbilisi, 0160
Belgium3 sites
Erasme Hospital
Brussels
University Hospital Antwerp (UZA)
Edegem
University Hospital Center Sart-Tilman
Liège
Taiwan3 sites
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 807377
E-Da Hospital
Kaohsiung City, 82445
National Taiwan University Hospital
Taipei, 100225
Hungary2 sites
Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases
Budapest, H-1097
Fejer County St. Gyorgy University Teaching Hospital
Székesfehérvár, H-8000
Israel2 sites
Soroka University Medical Center
Beersheba, 8410101
HaEmek Medical Center
Haifa, 3296043
Ukraine2 sites
Limited Liability Company "Medical Center Health and Rehabilitation "100 Percent Life"
Poltava, 36000
Public Non-Profit Enterprise "Central City Hospital" of Rivne City Council
Rivne, 33018
Bulgaria1 site
Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda
Sofia, 1407
Uzbekistan1 site
Research Institute of Virology of the Republic of Uzbekistan
Tashkent, 100194
About this study
Official title: A Randomized, Open-label, Multicenter, Phase 3 Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)
This is a Phase 3, global, randomized, open-label, multicenter trial designed to evaluate the safety and efficacy of chronic treatment with brelovitug (BJT-778) for chronic hepatitis delta virus (HDV) infection. The objective of this study is to test the safety and effectiveness of brelovitug compared to delayed treatment.
Read the detailed description
The study consists of 3 study arms. Approximately 80 participants will be randomized 2:1:1 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 brelovitug 900 mg subcutaneously once every 4 weeks for 96 weeks.
Arm 3: Participants will attend study clinic visits and delay treatment with brelovitug for 12 weeks. At Week 12, participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
- Conditions
- Chronic Hepatitis D Infection
- Being tested
- Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
- 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
Brelovitug 900 mgDrug
Also called BJT-778, BTG
Route of administration- Subcutaneous Injection
Delayed Treatment with Brelovitug 300mgDrug
Also called BJT-778, BTG
Route of administration- Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Brelovitug 300 mg | Experimental | Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks Receives: Drug: Brelovitug 300 mg |
| Brelovitug 900 mg | Experimental | Participants will receive treatment with brelovitug 900 mg once every 4 weeks with a loading dose at Week 2 for 96 weeks Receives: Drug: Brelovitug 900 mg |
| Delayed treatment with brelovitug 300 mg | Active comparator | Participants will have 12 weeks of delayed treatment followed by brelovitug 300 mg once weekly for 96 weeks Receives: Drug: Delayed Treatment with Brelovitug 300mg |
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 at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm
The composite endpoint is defined as virologic response (HDV RNA ≥2 log10 IU/mL decrease from Baseline or 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 24
Secondary outcomes (15)
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 to 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 <LLOQ, 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
Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.
Measured: Post-Treatment Weeks 24 and 48
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start14 Jan 2026
- Primary completionAug 2026 (estimated)
- Study completionJan 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
- 80 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
- NCT07298330
- Sponsor's protocol ID
- BJT-778-304
- Other IDs
- 2025-522105-38-00, 2025
- Status last verified
- Jun 2026
- First submitted
- 19 Dec 2025
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No