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Bjt-778

A groundbreaking clinical trial is underway to assess the potential of BJT-778, a new drug developed for patients with chronic hepatitis B and D infections. This Phase 1/2a study aims to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of BJT-778 in both healthy volunteers and individuals with chronic hepatitis B, including those with chronic hepatitis D infection. The trial represents a significant step forward in the search for effective treatments for these persistent viral infections.

Table of Contents

What is BJT-778?

BJT-778 is a new investigational drug being developed by Bluejay Therapeutics, Inc. It is currently undergoing clinical trials to evaluate its safety, effectiveness, and how it works in the body for treating chronic hepatitis B and chronic hepatitis D infections[1]. BJT-778 is a protein-based medication that is given as a solution for injection[1].

Medical Conditions Treated

BJT-778 is being studied for the treatment of two main conditions:

  • Chronic Hepatitis B Infection: This is a long-lasting liver infection caused by the hepatitis B virus (HBV). It can lead to serious liver problems if left untreated[1].
  • Chronic Hepatitis D Infection: Also known as hepatitis delta, this is a severe form of viral hepatitis caused by the hepatitis D virus (HDV). It only occurs in people who are also infected with hepatitis B[1].

How BJT-778 Works

While the exact mechanism of action is not fully described in the provided information, BJT-778 is being studied for its antiviral activity against both hepatitis B and hepatitis D viruses. The drug aims to reduce the levels of these viruses in the body and improve liver health[1].

Clinical Trial Details

The clinical trial for BJT-778 is a Phase 1/2a study, which means it’s in the early stages of testing in humans. Here are some key points about the trial:

  • It’s a randomized, placebo-controlled study, which helps determine if the drug is effective compared to no treatment[1].
  • The study includes both healthy volunteers and patients with chronic hepatitis B, including some with chronic hepatitis D[1].
  • The main goal is to evaluate the safety and tolerability of BJT-778[1].
  • Secondary goals include studying how the drug moves through the body (pharmacokinetics), how the immune system responds to it (immunogenicity), and how well it works against the hepatitis B and D viruses[1].

Eligibility Criteria

The study has specific criteria for who can participate. Some key inclusion criteria are:

  • Adults aged 18-70 years[1]
  • Chronic hepatitis B infection for at least 6 months[1]
  • Currently on specific antiviral medications for hepatitis B[1]
  • For some groups, detectable levels of hepatitis D virus[1]

There are also several exclusion criteria, such as having cirrhosis, other liver diseases, or certain medical conditions that might interfere with the study[1].

Safety and Effectiveness

The primary focus of this study is to assess the safety of BJT-778. Researchers will be monitoring:

  • Side effects that occur during treatment[1]
  • Changes in laboratory test results[1]
  • The body’s immune response to the drug[1]

To measure effectiveness, the study will look at:

  • Reduction in hepatitis B surface antigen (HBsAg) levels[1]
  • Reduction in hepatitis D virus RNA levels[1]
  • Changes in liver enzyme levels (ALT)[1]

Administration

BJT-778 is given as a subcutaneous injection, which means it’s injected just under the skin[1]. The exact dosing schedule and duration of treatment will be determined as part of the clinical trial.

Aspect Details
Study Type Phase 1/2a, Randomized, Placebo-Controlled
Drug Name BJT-778
Administration Subcutaneous injection
Target Conditions Chronic Hepatitis B and D infections
Primary Objective Evaluate safety and tolerability
Secondary Objectives Assess pharmacokinetics, immunogenicity, antiviral activity against HBV and HDV, effect on ALT levels
Key Inclusion Criteria Adults 18-70 years, chronic HBV infection, specific HBsAg levels, on stable nucleos(t)ide analog treatment
Key Exclusion Criteria Cirrhosis, significant liver enzyme abnormalities, other liver diseases, recent malignancy
Primary Endpoint Incidence of treatment-emergent adverse events and significant lab abnormalities
Key Secondary Endpoints Pharmacokinetic parameters, antidrug antibody development, reductions in HBsAg and HDV RNA levels

FAQ

  • What is BJT-778? BJT-778 is a new drug being studied for the treatment of chronic hepatitis B and D infections. It is administered as a solution for injection subcutaneously.
  • What is the main goal of this clinical trial? The main objective of this trial is to evaluate the safety and tolerability of BJT-778 in healthy volunteers and patients with chronic hepatitis B and D infections.
  • Who can participate in this study? The study includes male and female adults aged 18-70 with chronic hepatitis B infection, including some with chronic hepatitis D infection. Participants must meet specific criteria, such as having certain levels of hepatitis B surface antigen (HBsAg) and being on stable nucleos(t)ide analog treatment.
  • What will the researchers measure during the trial? Researchers will assess the safety of BJT-778 by monitoring side effects and laboratory abnormalities. They will also study how the drug moves through the body (pharmacokinetics), its antiviral activity against hepatitis B and D viruses, and its effects on liver enzyme levels.
  • How long will participants need to use contraception after the study? Both male and female participants who are sexually active must use acceptable contraception methods during the study and for at least 12 weeks after the last dose of the study drug.

Ongoing Clinical Trials on Bjt-778

  • A study comparing brelovitug to bulevirtide for treating chronic hepatitis delta infection in patients currently receiving bulevirtide

    Recruiting

    4 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia France Germany Italy Romania +1

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

    Recruiting

    3 1 1 1
    Investigated drugs:
    Austria Czechia France Germany Italy Romania +2

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

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Hungary

  • Study on BJT-778 for Patients with Chronic Hepatitis Delta Infection

    Not recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria

  • Study on BJT-778 for Patients with Chronic Hepatitis B and D Infections

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Romania

Glossary

  • Chronic Hepatitis B: A long-lasting liver infection caused by the hepatitis B virus, which can lead to liver damage, cirrhosis, and liver cancer if left untreated.
  • Chronic Hepatitis D: A liver infection caused by the hepatitis D virus, which only occurs in people who also have hepatitis B. It can cause more severe liver disease than hepatitis B alone.
  • Pharmacokinetics (PK): The study of how a drug moves through the body, including how it's absorbed, distributed, metabolized, and eliminated.
  • Antiviral activity: The ability of a drug to reduce or stop the growth and spread of viruses in the body.
  • HBsAg: Hepatitis B surface antigen, a protein on the surface of the hepatitis B virus that can be detected in blood tests and indicates an active hepatitis B infection.
  • Nucleos(t)ide analogs: A class of antiviral drugs used to treat chronic hepatitis B by interfering with viral replication.
  • Alanine aminotransferase (ALT): An enzyme found mainly in the liver. Elevated levels in the blood can indicate liver damage or inflammation.
  • Cirrhosis: Severe scarring of the liver, often caused by long-term liver diseases like chronic hepatitis.
  • Immunogenicity: The ability of a substance to provoke an immune response in the body, which can be measured by the presence of antidrug antibodies.
  • Antidrug antibodies (ADAs): Antibodies produced by the immune system in response to a drug, which can potentially affect the drug's safety and effectiveness.

References

  1. http://clinicaltrials.eu/trial/study-on-bjt-778-for-patients-with-chronic-hepatitis-b-and-d-infections/