Health Trials

Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide

ConditionChronic Hepatitis D
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMirum Pharmaceuticals, Inc.

About this trial

This is a Phase 2b/3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Willing and able to provide written informed consent.

Male or female, ≥18 years of age at Screening.

Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.

Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.

Disqualifiers

Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).

Known history of immune-complex disease.

Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).

Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brelovitug (BJT-778)

    Drug

    Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.

  • Bulevirtide

    Drug

    Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Immediate Switch to BrelovitugExperimental treatment 1 intervention
Group B: Delayed Switch from Bulevirtide to BrelovitugExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with undetectable HDV RNA (<LLOQ Target not detected [TND])

The proportion of participants with undetectable HDV RNA (\<LLOQ, TND) at Week 24

Time frame
Week 24

Secondary outcomes

1

Incidence and severity of treatment-emergent adverse events (TEAEs)

Incidence and severity of treatment-emergent adverse events (TEAEs) during brelovitug and bulevirtide treatment periods.

Time frame
Up to Week 96
2

Proportion of participants who permanently discontinue treatment due to an adverse event

Proportion of participants who permanently discontinue study treatment because of an adverse event.

Time frame
Up to Week 96
3

Change from baseline in serum total bile salts

Mean change from baseline in serum total bile salt levels.

Time frame
Up to Week 96
4

Proportion of participants achieving virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)

Proportion of participants with virologic response at Weeks 24, 48, 72, and 96.

Time frame
Up to Week 96

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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