RecruitingPhase 3

A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)

Austria, Czechia172 participantsStarted 2025-08-27

Plain-language 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). 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.

Who can participate

Age range18 Years – 99 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Percentage of participants with a composite endpoint of virologic response and ALT normalization

Timeframe: Week 48

Trial details

NCT IDNCT07200908

SponsorMirum Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Clinical Trials Clinical Trials Mirum

+16506674085 clinicaltrials@mirumpharma.com

View on ClinicalTrials.gov More Chronic Hepatitis D Infection trials