An expanded access record providing Brelovitug in Chronic Hepatitis, Delta Virus, sponsored by Mirum Pharmaceuticals, Inc.. Available at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Mirum Pharmaceuticals, Inc. · Expanded access
Brelovitug is designed to target or bind to a key protein on the surface of hepatitis D and hepatitis B viruses, known as the hepatitis B surface antigen (HBsAg). By targeting this protein, brelovitug may help neutralize virus particles and support their removal from the bloodstream.
The aim of this expanded-access program (EAP) is to make brelovitug available to patients with Chronic Hepatitis D (CHD) who are in medical need, cannot benefit from any other comparable authorized treatment, and cannot participate in any available clinical trial.
This expanded access program provides brelovitug at no cost to eligible adults with chronic hepatitis D who have no comparable approved treatment option, cannot tolerate or continue approved therapy, or are not candidates for approved therapy based on the treating physician's clinical judgment.
Patients must be unable or ineligible to participate in an available brelovitug clinical trial. All patients must meet the following criteria to be considered eligible for program entry:
Patients aged ≥18 years for whom, in the judgment of the treating physician, treatment with brelovitug is clinically appropriate based on efficacy, safety, or other relevant clinical considerations.
43 studies on the registry are indexed under Hepatitis D, Chronic; 9 are open to participants now.
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.
Compared within Hepatitis D, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hepatitis, Chronic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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.
Patients aged ≥18 years for whom, in the judgment of the treating physician, treatment with brelovitug is clinically appropriate based on efficacy, safety, or other relevant clinical considerations.
Exclusion Criteria:
Current or prior hepatic decompensation (ascites, hepatic encephalopathy, variceal hemorrhage, etc) or Child-Turcotte-Pugh (CTP) Class B or C cirrhosis.
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.
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.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
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.
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.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Brelovitug (BJT-778) is an investigational, fully human monoclonal antibody targeting hepatitis B surface antigen (HBsAg). Eligible patients with chronic hepatitis D (CHD) will receive brelovitug 300 mg administered as a single subcutaneous injection once weekly in the abdomen, upper arm, or thigh. Treatment may be self-administered by appropriately trained patients or administered by healthcare professionals. Treatment will continue as long as the patient derives clinical benefit, as determined by the treating physician, or until treatment discontinuation criteria are met.
Also known as: BJT-778
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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