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Clinical Trial for Patients with Chronic Hepatitis D: Comparing Brelovitug and Bulevirtide Treatments

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What is this trial about?

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

This clinical trial is studying the treatment of Chronic Hepatitis D Infection (CHD), a viral liver disease that occurs in people already infected with hepatitis B virus. The study compares two medications: brelovitug (BJT-778) and bulevirtide (BLV). Both drugs are designed to treat this infection by preventing the virus from entering liver cells. The purpose of the study is to evaluate how effective brelovitug is compared to bulevirtide in treating chronic hepatitis D infection over a 48-week period.

During the study, participants will receive either brelovitug or bulevirtide. Participants will continue taking their current hepatitis B medication (either tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or entecavir) throughout the trial. The researchers will monitor participants' HDV RNA (the genetic material of the hepatitis D virus in the blood) and ALT levels (a liver enzyme that, when elevated, indicates liver damage). The study will also track changes in liver stiffness (a measure of liver scarring) and assess participants' quality of life and fatigue levels during treatment.

The study will last 96 weeks (approximately 2 years), with the main comparison between the two treatments occurring at the 48-week mark. Researchers will evaluate whether the treatments can make the virus undetectable in the blood and normalize liver enzyme levels, indicating improved liver function. They will also monitor for any side effects or adverse events throughout the study period.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Starting the Trial

    You will begin the trial after qualifying for participation based on criteria including being at least 18 years old, having chronic hepatitis D infection (confirmed by a positive anti-HDV antibody test or HDV RNA at least 6 months before starting), having HDV RNA levels above 500 IU/mL, and elevated liver enzymes (ALT above normal limits).

    You will need to be taking or willing to take one of these hepatitis B medications: tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or entecavir (ETV). You must continue taking this medication throughout the study.

  2. Step 2

    Randomization and Treatment Assignment

    You will be randomly assigned to receive either brelovitug (BJT-778) or bulevirtide (BLV). Both are solutions for injection used to treat chronic hepatitis D infection.

    The study is open-label, which means both you and your healthcare providers will know which medication you are receiving.

  3. Step 3

    Treatment Period (Weeks 0-48)

    You will receive your assigned medication (brelovitug or bulevirtide) via injection for 48 weeks.

    Throughout this period, you will need to continue taking your hepatitis B medication (TDF, TAF, or ETV) as prescribed.

    You will attend regular clinic visits for blood tests to monitor your HDV RNA levels (amount of hepatitis D virus in your blood) and ALT levels (a liver enzyme that indicates liver health).

  4. Step 4

    Assessment at Week 24

    At Week 24, you will undergo several assessments including:

    Blood tests to check HDV RNA levels and liver function

    A liver stiffness test (using FibroScan, a non-invasive procedure similar to an ultrasound that measures liver stiffness)

    Calculation of APRI (AST-to-platelet ratio index, a blood test that helps assess liver fibrosis)

    If you have cirrhosis, additional tests to calculate your CTP score and MELD score (measures of liver function and disease severity)

    Quality of life questionnaires: CLDQ-HBV (Chronic Liver Disease Questionnaire) and FACIT-F (assessing fatigue levels)

  5. Step 5

    Primary Endpoint Assessment (Week 48)

    At Week 48, you will have a comprehensive evaluation to assess if you've achieved the main goal of the treatment: undetectable HDV RNA (virus levels below detection) and normalized ALT (liver enzyme levels returned to normal range).

    You will undergo the same tests performed at Week 24 (blood tests, liver stiffness measurement, APRI calculation, and quality of life questionnaires).

    If you have cirrhosis, your CTP and MELD scores will be calculated again to track changes in liver function.

  6. Step 6

    Extended Treatment Period (Weeks 48-96)

    The study continues for another 48 weeks (96 weeks total).

    If you were in the bulevirtide group (Arm 2), you may switch treatments at Week 48.

    You will continue to receive treatment and attend regular clinic visits for monitoring.

  7. Step 7

    Follow-up Assessments (Weeks 72 and 96)

    At Weeks 72 and 96, you will undergo assessments similar to those at Week 48 to determine if treatment benefits are maintained.

    The Week 96 visit will include the final comprehensive evaluation with all tests performed previously (blood tests, liver stiffness measurement, APRI calculation, and quality of life questionnaires).

    If you have cirrhosis, your CTP and MELD scores will be calculated one final time.

  8. Step 8

    Safety Monitoring Throughout the Trial

    Throughout the entire 96-week study period, you will be monitored for any treatment-emergent adverse events (side effects).

    Your serum total bile acid levels will be measured to monitor for potential side effects.

    An Independent Data Monitoring Committee will assess if there are any signs of clinical disease progression related to hepatitis D.

Who can join the trial?

6 criteria

  • Willing and able to provide written informed consent
  • At least 18 years of age at Screening
  • Have chronic hepatitis D infection, confirmed by a positive test for anti-HDV antibodies or HDV RNA at least 6 months before starting the study
  • Have HDV RNA levels greater than 500 IU/mL at Screening (this measures the amount of hepatitis D virus in your blood)
  • Have ALT levels higher than the upper limit of normal at Screening (ALT is a liver enzyme that can indicate liver damage when elevated)
  • Currently taking or willing to take antiviral medications (tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or entecavir) at the start of the study, and willing to continue this treatment throughout the study duration

Who cannot join the trial?

12 criteria

  • You have liver cirrhosis that is considered advanced (Child-Pugh class B or C). This means your liver disease has reached a stage where it's causing more significant health problems.
  • You have a liver tumor (hepatocellular carcinoma).
  • You have co-infection with HIV (human immunodeficiency virus).
  • You are currently experiencing a flare-up of your hepatitis or your liver disease is getting worse.
  • You have previously been treated with bulevirtide or lonafarnib.
  • You have certain abnormal blood test results that indicate liver or kidney problems.
  • You have uncontrolled high blood pressure.
  • You have a history of severe heart problems.
  • You have a history of cancer in the past 5 years (except for certain skin cancers).
  • You are pregnant or breastfeeding.
  • You have a history of drug or alcohol abuse within the past 12 months.
  • You are currently participating in another clinical trial.
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Investigated drugs

  • Brelovitug

    is an experimental medication being studied as a treatment for chronic hepatitis delta infection. It works by targeting the virus that causes hepatitis delta and may help reduce the amount of virus in the body, potentially improving liver health in infected individuals.

  • Bulevirtide

    is an approved medication for treating chronic hepatitis delta. It works by blocking the entry of the hepatitis delta virus into liver cells. By preventing the virus from infecting more cells, it may help reduce liver inflammation and damage in people with chronic hepatitis delta infection.

What is already known about the treatment

  • Brelovitug

    An investigational drug being studied for chronic hepatitis D infection, which is administered via injection. Brelovitug is currently in Phase 3 clinical trials (AZURE-2 study) where it's being compared to bulevirtide for treating chronic hepatitis delta infection. It likely works by blocking the hepatitis D virus from entering liver cells, preventing viral replication and reducing liver inflammation. Brelovitug belongs to the class of entry inhibitors that target specific receptors needed for the virus to infect cells.

  • Bulevirtide

    An approved medication for chronic hepatitis D infection that is administered as a subcutaneous injection, typically once daily. Bulevirtide (also known as Myrcludex B) is the first approved treatment specifically for hepatitis D, receiving conditional approval in Europe in 2020. It works by blocking the NTCP receptor on liver cells, which prevents the hepatitis D virus from entering and infecting these cells. Bulevirtide is classified as an entry inhibitor and represents an important therapeutic option for a difficult-to-treat viral infection that previously had limited treatment options.

Investigated diseases

Hepatitis D (Hepatitis Delta) – An inflammatory liver disease caused by the hepatitis delta virus (HDV), which can only infect individuals already infected with hepatitis B virus (HBV). It is considered the most severe form of viral hepatitis, leading to rapid progression of liver damage compared to hepatitis B alone. The disease can manifest as either acute or chronic infection, with chronic hepatitis D often progressing to liver fibrosis and cirrhosis over time. In chronic infection, the virus continuously replicates in the liver, causing persistent inflammation and progressive damage to liver cells. This ongoing damage can lead to increasing liver stiffness and declining liver function as measured by various clinical markers.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517167-23-00Protocol codeBJT-778-302Estimated enrolment172 patientsSponsorMirum Pharmaceuticals Inc.

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