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Study identifier: NCT07298330 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Active Not Recruiting

A Trial Evaluating Brelovitug vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-4)

Condition: Chronic Hepatitis D Infection  ·  Sponsor: Mirum Pharmaceuticals, Inc.

PhasePhase 3
Planned participants80
Who can joinAll sexes, 18 Years to 99 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where27 locations · 10 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (27)

University of California, DavisDavis, California, United States
Kaiser Permanente Medical CenterSacramento, California, United States
Quest Clinical ResearchSan Francisco, California, United States
Denver Health Medical CenterDenver, Colorado, United States
Alliance Clinical, Las VegasLas Vegas, Nevada, United States
Cleveland ClinicCleveland, Ohio, United States
Prime Clinical Research IncMansfield, Texas, United States
University of UtahSalt Lake City, Utah, United States
Erasme HospitalBrussels, Belgium
University Hospital Antwerp (UZA)Edegem, Belgium
University Hospital Center Sart-TilmanLiège, Belgium
Acibadem City Clinic University Multiprofile Hospital for Active Treatment TokudaSofia, Bulgaria

+ 15 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

DavisSacramentoSan FranciscoDenver

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