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

Sponsors and collaborators