A Phase 2/3 interventional study of Brelovitug (BJT-778) and Bulevirtide in Chronic Hepatitis D, sponsored by Mirum Pharmaceuticals, Inc.. Recruiting at 46 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Mirum Pharmaceuticals, Inc. · Phase 2/3, Interventional, and Treatment
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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).
43 studies on the registry are indexed under Hepatitis D, Chronic; 9 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 30 interventional studies indexed under Hepatitis D, Chronic.
Browse Hepatitis D, Chronic studies →Mirum Pharmaceuticals, Inc. is the lead sponsor of 40 studies on the registry; 7 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorized to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
No publications or documents are linked to this record.
Started Feb 2026 (actual). Primary completion is estimated for Aug 2027, 18 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Brelovitug · Bulevirtide