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New hope for hepatitis delta: phase 3 trial of brelovitug launches

NCT ID NCT07298330

Disease control Sponsor: Mirum Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 30, 2026 · Updated 3 times

Summary

This Phase 3 trial tests a drug called brelovitug (BJT-778) in 80 people with chronic hepatitis delta, a serious liver infection. Participants receive either brelovitug or delayed treatment to see if the drug can lower virus levels and improve liver enzyme counts. The study is recruiting now and aims to find a safer, more effective way to manage this disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Brelovitug (also called BJT-778), a drug given as a shot under the skin
What this could lead to
If it works, this could offer a new treatment option to control hepatitis delta virus and reduce liver damage, potentially preventing progression to cirrhosis or liver failure.
What could go wrong
This is still an early Phase 3 trial with only 80 participants, so results may not apply to everyone. The drug may cause side effects, and it is not a cure—patients may need ongoing treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Jan 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Willing and able to provide written informed consent 2. Chronic HDV infection 3. HDV RNA \>500 IU/mL at Screening 4. ALT \>ULN at Screening 5. Willing to take or already taking HBV nucleos(t)ide therapy. Exclusion Criteria: 1. Pregnant or nursing females 2. Unwilling to comply with contraception requirements during the study 3. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy 4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). 5. Solid organ or bone marrow transplantation 6. 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.

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Conditions

The condition(s) this trial relates to.

hepatitis D virus infection

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic hepatitis D infection

Contacts and locations

Locations

  • Acibadem City Clinic University Multiprofile Hospital for Active Treatment Tokuda

    Sofia, 1407, Bulgaria

  • Aga Khan University & Hospital

    Karachi, Karachi, 74800, Pakistan

  • Alliance Clinical, Las Vegas

    Las Vegas, Nevada, 89019, United States

  • Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases

    Budapest, H-1097, Hungary

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Denver Health Medical Center

    Denver, Colorado, 80204, United States

  • Diakori LLC

    Tbilisi, 0159, Georgia

  • E-Da Hospital

    Kaohsiung City, 82445, Taiwan

  • Erasme Hospital

    Brussels, Belgium

  • Fejer County St. Gyorgy University Teaching Hospital

    Székesfehérvár, H-8000, Hungary

  • HaEmek Medical Center

    Haifa, 3296043, Israel

  • Hospital Service LTD

    Kutaisi, 4608, Georgia

  • JSC T. Tsertsvadze Infectious Diseases, AIDS and Clinical Immunology Research Center

    Tbilisi, 0159, Georgia

  • Kaiser Permanente Medical Center

    Sacramento, California, 95661, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807377, Taiwan

  • LTD Academician Vakhtang Bochorishvili Clinic

    Tbilisi, 0160, Georgia

  • Limited Liability Company "Medical Center Health and Rehabilitation "100 Percent Life"

    Poltava, 36000, Ukraine

  • National Taiwan University Hospital

    Taipei, 100225, Taiwan

  • Prime Clinical Research Inc

    Mansfield, Texas, 76063, United States

  • Public Non-Profit Enterprise "Central City Hospital" of Rivne City Council

    Rivne, 33018, Ukraine

  • Quest Clinical Research

    San Francisco, California, 94115, United States

  • Research Institute of Virology of the Republic of Uzbekistan

    Tashkent, 100194, Uzbekistan

  • Soroka University Medical Center

    Beersheba, 8410101, Israel

  • University Hospital Antwerp (UZA)

    Edegem, Belgium

  • University Hospital Center Sart-Tilman

    Liège, Belgium

  • University of California, Davis

    Davis, California, 95616, United States

  • University of Utah

    Salt Lake City, Utah, 84132, United States

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