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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-99
SponsorMirum Pharmaceuticals, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

Willing and able to provide written informed consent

Chronic HDV infection

HDV RNA >500 IU/mL at Screening

ALT >ULN at Screening

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Brelovitug 300 mg
  • Bulevirtide 2 mg and Brelovitug - 300 mg

Treatment groups

172 Participants
are divided into 2 treatment groups

Locations

48
Austria
Medical University of Graz8036, Graz Austria
Universitätsklinikum St. Pölten3100, Sankt Pölten Austria
Czechia
Fakultni Nemocnice Brno62500, BrnoBrno, Czechia
Fakultni Nemocnice Hradec Kralove500 03, Hradec KrálovéHradec Králové, Czechia

Sponsors and collaborators

Mirum Pharmaceuticals, Inc.

Lead sponsor