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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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 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

Other trials in United States

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

Other trials in Georgia

Belgium3 sites

  • Erasme Hospital

    Brussels

  • University Hospital Antwerp (UZA)

    Edegem

  • University Hospital Center Sart-Tilman

    Liège

Other trials in Belgium

Taiwan3 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377

  • E-Da Hospital

    Kaohsiung City, 82445

  • National Taiwan University Hospital

    Taipei, 100225

Other trials in Taiwan

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

Other trials in Hungary

Israel2 sites

  • Soroka University Medical Center

    Beersheba, 8410101

  • HaEmek Medical Center

    Haifa, 3296043

Other trials in Israel

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

Other trials in Ukraine

Bulgaria1 site

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda

    Sofia, 1407

Other trials in Bulgaria

Pakistan1 site

  • Aga Khan University & Hospital

    Karachi, Karachi, 74800

Other trials in Pakistan

Uzbekistan1 site

  • Research Institute of Virology of the Republic of Uzbekistan

    Tashkent, 100194

Other trials in Uzbekistan

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.

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 groups in NCT07298330
Study groupRoleWhat they receive
Brelovitug 300 mgExperimentalParticipants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Receives: Drug: Brelovitug 300 mg
Brelovitug 900 mgExperimentalParticipants 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 mgActive comparatorParticipants 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.

  1. 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)

  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 to 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 <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

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

    Measured: Post-Treatment Weeks 24 and 48

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

    Measured: Up to 96 Weeks

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

    Measured: Up to 96 Weeks

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

    Measured: Up to 96 Weeks

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

    Measured: Up to 96 Weeks

  15. 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.

  1. First posted23 Dec 2025
  2. Study start14 Jan 2026
  3. Primary completionAug 2026 (estimated)
  4. Study completionJan 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
80 participants (estimated)
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

Questions about this trial

What is this clinical trial studying?

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.

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: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Georgia, Belgium, Taiwan, Hungary and 5 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 at Week 24 in brelovitug arms compared to response at Week 12 of delayed-treatment arm (time frame: Week 24). 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 NCT07298330.

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 29 Jun 2026.

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