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A Study of Brelovitug Compared to Delayed Treatment in Patients with Chronic Hepatitis Delta Infection

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at Chronic Hepatitis Delta Infection, which is a liver disease caused by the hepatitis delta virus. This virus infects people who already have hepatitis B and can cause serious liver damage over time. The treatment being tested is called brelovitug, which is also known by its code name BJT-778. This medicine is given as an injection under the skin. The purpose of the study is to see how well brelovitug works at week 24 compared with delayed treatment on chronic hepatitis delta at week 12.

During the study, some people will receive brelovitug while others will have their treatment delayed. All people taking part will also need to take one of the following medicines for hepatitis B: tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or entecavir. The study will measure whether the virus levels in the blood decrease by a certain amount or become undetectable, and whether liver enzyme levels return to normal. Liver enzyme is a substance in the blood that shows how well the liver is working, and when it is high, it can mean the liver is inflamed or damaged.

The study will also look at the safety of the treatment by checking for any unwanted effects and how many people need to stop treatment because of these effects. Other measurements will include checking liver stiffness, which shows how much scarring has occurred in the liver, and various scores that help doctors understand how well the liver is functioning. These checks will happen at different times during the study, including at weeks 24, 48, and 96 of treatment. The study is expected to last until early 2028.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline and Treatment Assignment

    At the start of the trial, your current health status will be assessed and recorded as your baseline. This includes measuring your HDV RNA (the amount of hepatitis delta virus in your blood) and your ALT levels (a liver enzyme that indicates liver inflammation).

    You will be randomly assigned to one of two groups: either you will begin receiving brelovitug treatment immediately, or you will be assigned to a delayed treatment group where you will start treatment at a later time.

    You will continue taking your current hepatitis B medication (tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or entecavir) throughout the entire study at the same dose you are currently taking.

  2. Step 2

    Treatment with BJT-778 (Brelovitug)

    If you are assigned to immediate treatment, you will receive BJT-778 (also called brelovitug), which is given as an injection under the skin (subcutaneous injection).

    The medication is provided as a solution for injection.

    The specific dosage, frequency, and exact schedule of injections will be determined by the study protocol.

    If you are assigned to the delayed treatment group, you will begin receiving brelovitug after Week 12.

  3. Step 3

    Week 12 Assessment

    At Week 12, your response to treatment will be evaluated if you are in the immediate treatment group.

    If you are in the delayed treatment group, assessments will be performed at Week 12, and you will then begin receiving brelovitug treatment.

    Your HDV RNA levels and ALT levels will be measured to assess how the infection and liver inflammation are responding.

  4. Step 4

    Week 24 Assessment

    At Week 24, a comprehensive evaluation will be conducted to determine treatment effectiveness.

    The assessment will measure whether you have achieved a virologic response, which means your HDV RNA has decreased by at least 100-fold from baseline or has become undetectable.

    Your ALT normalization will also be checked, meaning your ALT levels have decreased to normal or below the upper limit of normal.

    Additional measurements will include liver stiffness (measured by a non-invasive test called transient elastography), APRI score (a calculation using liver enzyme and platelet levels to assess liver damage), and if you have cirrhosis, your CTP score (Child-Turcotte-Pugh score) and MELD score (Model for End-Stage Liver Disease score) will be evaluated to assess liver function.

  5. Step 5

    Week 48 Assessment

    At Week 48, similar assessments to those performed at Week 24 will be repeated.

    Your HDV RNA levels will be measured to determine virologic response.

    Your liver stiffness, APRI score, and if applicable, your CTP score and MELD score will be assessed to monitor changes in liver health.

    Any signs of disease progression will be evaluated.

  6. Step 6

    Week 96 Assessment and Treatment Completion

    At Week 96, final assessments will be conducted.

    All measurements from previous assessments will be repeated, including HDV RNA levels, liver stiffness, APRI score, and if you have cirrhosis, CTP score and MELD score.

    The overall progression of your liver disease from the start of the trial will be evaluated.

    This marks the completion of the treatment phase of the trial.

  7. Step 7

    Safety Monitoring Throughout the Trial

    Throughout the entire trial, any side effects or adverse events you experience will be recorded and assessed for severity.

    Your healthcare team will monitor whether any side effects are related to the treatment.

    If you experience side effects that require stopping the treatment permanently, this will be documented.

    Safety monitoring is continuous from the start of treatment through Week 96 and beyond.

Who can join the trial?

7 criteria

  • You must be willing and able to provide written informed consent, which means you agree to participate in the study after understanding all the details
  • You must be at least 18 years of age or older at the time of screening
  • You must have chronic HDV infection, which is a long-term liver infection caused by the hepatitis delta virus. This must be confirmed by either a positive anti-HDV antibody test (a blood test showing your body has been exposed to the virus) or HDV RNA (the genetic material of the virus) present for at least 6 months before starting the study. If you do not have previous test results, you can qualify if you have HDV RNA in your blood and signs of fibrosis (scarring of the liver) shown by liver stiffness of at least 7 kPa measured by a special test
  • Your blood test must show HDV RNA levels greater than 500 IU/mL at the screening visit
  • Your ALT (a liver enzyme that shows liver inflammation) must be higher than the upper limit of normal at screening
  • You must be currently taking or willing to take one of these medications: tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or entecavir (medicines used to control hepatitis B virus) at the start of the study, and you must agree to continue taking the same medication throughout the entire study
  • If you live in a country where HDV treatment is approved and available, you must have documented reasons for being unwilling or unable to receive that treatment

Who cannot join the trial?

1 criterion

  • The study information provided does not include specific reasons why patients cannot participate in this trial. The exclusion criteria, which are conditions or factors that would prevent someone from joining the study, have not been listed in the available data.
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Investigated drugs

  • Brelovitug

    is an investigational medication being studied for the treatment of chronic hepatitis delta infection. This is an experimental drug that aims to help patients with this liver condition by targeting the virus that causes the disease.

  • Delayed treatment

    refers to a comparison group in this study where participants will receive treatment at a later time point. This approach helps researchers understand how effective the medication is by comparing outcomes between those who receive treatment right away and those who start treatment later.

What is already known about the treatment

Brelovitug – Brelovitug is an investigational medication currently being studied in clinical trials for the treatment of chronic hepatitis delta infection, which is a serious liver disease caused by the hepatitis delta virus. This medication is administered as part of a phase 3 clinical trial to evaluate its effectiveness compared to delayed treatment approaches. While the exact mechanism of action at the molecular level is still under investigation, brelovitug is designed to target specific pathways involved in hepatitis delta virus infection to help reduce viral activity and improve liver health. The medication belongs to a class of antiviral therapeutic agents being developed to address this difficult-to-treat form of chronic hepatitis.

Investigated diseases

Chronic Hepatitis Delta – Chronic Hepatitis Delta is a long-term liver infection caused by the hepatitis D virus, which can only occur in people who are already infected with hepatitis B virus. The virus attacks liver cells and causes ongoing inflammation of the liver tissue. Over time, this continuous inflammation damages the liver and can lead to scarring of the liver tissue, a process called fibrosis. As the disease progresses, the amount of scar tissue increases and the liver's ability to function properly decreases. The infection is characterized by elevated levels of certain liver enzymes in the blood, particularly alanine aminotransferase (ALT) and aspartate aminotransferase (AST), which indicate liver cell damage. The virus can be detected in the blood through specific tests that measure hepatitis D virus RNA levels.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522105-38-00Protocol codeBJT-778-304Estimated enrolment120 patientsSponsorMirum Pharmaceuticals Inc.

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