A Phase 2/3 interventional study of Brelovitug (BJT-778) and Bulevirtide in Chronic Hepatitis D, sponsored by Mirum Pharmaceuticals, Inc.. Recruiting at 44 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Mirum Pharmaceuticals, Inc. · Phase 2/3, Interventional, and Treatment
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).
This is a Phase 2b/3, open-label, multicenter study evaluating the efficacy and safety of switching participants on bulevirtide to brelovitug for the treatment of chronic hepatitis delta (CHD).
Exclusion Criteria:
Participants will switch to brelovitug 300 mg once weekly for 96 weeks.
Drug: Brelovitug (BJT-778)
Participants will continue bulevirtide once daily and then switch to brelovitug 300 mg once weekly for 72 weeks.
Drug: Bulevirtide
Brelovitug (BJT-778), 300 mg administered subcutaneously once weekly for 96 weeks.
Also known as: BJT-778
Bulevirtide - once daily. Brelovitug (BJT-778) - 300 mg once weekly for 72 weeks following bulevirtide.
Also known as: BJT-778, Hepcludex
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
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
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
Change from baseline in serum total bile salts
Mean change from baseline in serum total bile salt levels.
Time frame: Up to Week 96
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
Proportion of participants achieving HDV RNA < LLOQ at Weeks 24, 48, 72 and 96.
Time frame: Up to Week 96
Proportion of participants achieving HDV RNA (HDV RNA < LLOQ, TND) at Weeks 48, 72, and 96.
Time frame: Up to Week 96
Proportion of participants achieving normal ALT at Weeks 24, 48, 72 and 96.
Time frame: Up to Week 96
Proportion of participants achieving normal ALT with virologic response (HDV RNA ≥2 log10 IU/mL decline from baseline or HDV RNA <LLOQ, TND)
Proportion of participants with normal ALT and virologic response at Weeks 24, 48, 72, and 96.
Time frame: Up to Week 96
Proportion of participants achieving normal ALT with HDV RDA < LLOQ at Weeks 24, 48, 72 and 96.
Time frame: Up to Week 96
Proportion of participants achieving normal ALT with HDV RNA (HDV RNA < LLOQ, TND) at Weeks 24, 48, 72 and 96
Time frame: Up to Week 96
Change from baseline in HDV RNA
Change from baseline in HDV RNA levels over time during treatment.
Time frame: Up to Week 96
Change from baseline in ALT levels
Change from baseline ALT levels over time during treatment.
Time frame: Up to Week 96
Change from baseline in liver stiffness
Change from baseline in liver stiffness as determined by transient elastography at weeks 24, 48 and 96
Time frame: Up to Week 96
Change from baseline in APRI
Change from baseline in APRI at weeks 24, 48, and 96
Time frame: Up to Week 96
Change in baseline in CTP score
Change from baseline in CTP score at Weeks 24, 48, and 96 in participants with cirrhosis
Time frame: Up to Week 96
Change from baseline in MELD score
Change from baseline in MELD score at Weeks 24, 48, and 96 in participants with cirrhosis
Time frame: Up to Week 96
Proportion of participants with clinical disease progression from baseline
Proportion of participants with clinical disease progression from baseline in HDV-associated liver disease at Weeks 24, 48, and 96.
Time frame: Up to Week 96
Proportion of participants who achieve HDV RNA < LLOQ, TND at post-treatment follow-up
Time frame: Up to Week 48
Plan to share: No
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Mirum Pharmaceuticals, Inc.