A Phase 3 interventional study of Brelovitug 300 mg and Bulevirtide 2 mg and Brelovitug - 300 mg in Chronic Hepatitis D Infection, sponsored by Mirum Pharmaceuticals, Inc.. Recruiting at 57 sites in 12 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Mirum Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
Study consists of 2 arms. Approximately 172 participants will be randomized 3:1 to one of the following treatment arms:
Arm 1: Participants will receive brelovitug 300 mg subcutaneously once weekly for 96 weeks.
Arm 2: Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.
63 studies on the registry are indexed under Hepatitis D; 21 are open to participants now.
This study's planned enrollment of 172 is above the median of 80 across 30 interventional studies indexed under Hepatitis D.
Browse Hepatitis D 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.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note - Other protocol-defined Inclusion/Exclusion criteria apply.
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 authorised 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.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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 authorised 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.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive treatment with brelovitug 300 mg once weekly for 96 weeks
Drug: Brelovitug 300 mg
Participants will receive bulevirtide 2 mg subcutaneously once daily for 48 weeks, followed by brelovitug 300 mg subcutaneously once weekly for the next 48 weeks.
Drug: Bulevirtide 2 mg and Brelovitug - 300 mg
Route of administration- Subcutaneous Injection
Also known as: BJT-778, BTG
Drug page: Bulevirtide
Route of Administration- Subcutaneous Injection
Also known as: Hepcludex
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
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
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
Percentage of participants with HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND
Time frame: Up 96 Weeks
Percentage of participants with HDV RNA <LLOQ
Time frame: Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ, TND
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization
ALT normalization is defined as a decrease in ALT from baseline to ≤ ULN
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization in combination with virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND
The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA ≥ 2 log10 IU/mL decline from baseline or TND.
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ
The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \<LLOQ.
Time frame: Up to 96 Weeks
Percentage of participants with ALT normalization in combination with HDV RNA <LLOQ, TND
The composite of participants with ALT normalization (decrease in ALT from baseline to ≤ ULN) and virologic response of HDV RNA \<LLOQ, TND.
Time frame: Up to 96 Weeks
Change from baseline in liver stiffness as determined by transient elastography (e.g., FibroScan)
Time frame: Up to 96 Weeks
Change from baseline in APRI (AST-to-platelet ratio index)
Time frame: Up to 96 Weeks
Change from baseline in CTP score in participants with cirrhosis
Time frame: Up to 96 Weeks
Change from baseline in Model for End-Stage Liver Disease (MELD) score in participants with cirrhosis
Time frame: Up to 96 Weeks
Percentage of participants with clinical disease progression from baseline in HDV-associated liver disease.
Liver disease progression will be determined by the Independent Data Monitoring Committee (IDMC).
Time frame: Up to 96 Weeks
Percentage of participants with HDV RNA <LLOQ, TND at post-treatment follow up.
Time frame: Post-Treatment Weeks 24 and 48
Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Chronic Liver Disease Questionnaire-HBV (CLDQ-HBV)
Time frame: Up to 96 Weeks
Change from baseline in Health-Related Quality of Life (HRQoL) as measured by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time frame: Up to 96 Weeks
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Jun 2027, 22 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 ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Brelovitug