Health Trials

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

ConditionChronic Hepatitis D Infection
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Brelovitug 300 mg

    Drug

    Route of administration- Subcutaneous Injection

  • Bulevirtide 2 mg and Brelovitug - 300 mg

    Drug

    Route of Administration- Subcutaneous Injection

Treatment groups

172 Participants
are divided into 2 treatment groups
Group A: BrelovitugExperimental treatment 1 intervention
Group B: Bulevirtide for 48 weeks followed by brelovitug for 48 weeksActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

The composite endpoint is defined as virologic response (undetectable HDV RNA, \< the lower limit of quantification \[LLOQ\], target not detected \[TND\]) and ALT normalization (decrease in ALT from baseline to ≤ upper limit of normal \[ULN\])

Time frame
Week 48

Secondary outcomes

1

Percentage of participants with treatment-emergent adverse events (TEAEs)

An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

Time frame
Up to 96 weeks
2

Percentage of participants who discontinue treatment due to an adverse event (AE)

An AE is any symptom, physical sign, syndrome, or disease that either emerges during the study or, if present at Screening (e.g., medical history), worsens during the study (post-Baseline/ Day 1), regardless of the suspected cause of the event.

Time frame
Up to 96 weeks
3

Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND

Time frame
Up 96 Weeks
4

Percentage of participants with HDV RNA <LLOQ

Time frame
Up to 96 Weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mirum Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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