Bepirovirsen treatment for chronic hepatitis B

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    What is this study about?

    This study investigates the effectiveness and safety of a new treatment, bepirovirsen, for chronic Hepatitis B in patients already taking specific antiviral drugs. Participants will be divided into groups, receiving either bepirovirsen or a placebo, followed by their usual antiviral medication. The study consists of four stages, including initial treatment, continued antiviral therapy, a phase where some may stop their antiviral drugs, and a final follow-up. The goal is to see if bepirovirsen can improve Hepatitis B outcomes compared to standard treatment alone. The study will take place over approximately 104 weeks, with eligibility criteria ensuring participants have chronic Hepatitis B and are on stable antiviral therapy.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Clichy Cedex , France

      Milano , Italy

      Bytom , Poland

      Barcelona , Spain

      Barcelona , Spain

      Madrid , Spain

      You can join this study in:

      Spain: Barcelona, Madrid.

      Poland: Bytom.


      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The clinical trial you are referring to involves several key steps for participating patients. Here is an outlined summary of these steps:

      1. Screening Phase: Before any treatment begins, patients will go through a screening process which can take up to 60 days.
      2. Double-blind Treatment Phase: For the first 24 weeks, patients will receive either bepirovirsen or a placebo without knowing which one they are receiving.
      3. Nucleos(t)ide Analogue (NA) Treatment Phase: Following the double-blind treatment, there will be a 24-week period where patients will receive NA treatment.
      4. NA Cessation Stage: After the NA treatment phase, patients may either stop the NA treatment or continue it for another 24 weeks depending on individual circumstances.
      5. Follow-Up Phase: There will be a durability of response and follow-up period for 24 weeks for participants who stopped NA treatment at Week 48.

      This comprehensive approach is designed to evaluate the efficacy of bepirovirsen compared to placebo in achieving hepatitis B surface antigen (HBsAg) suppression. The total duration of the study can be up to approximately 104 weeks at maximum for each participant.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      Based on the eligibility criteria in the clinical trial information, to join this study you need to have:

      • Documented chronic Hepatitis B virus (HBV) infection for at least 6 months prior to screening

      The key exclusion criteria related to diseases that would prevent you from joining the study include:

      • Clinically significant abnormalities in medical history, aside from chronic HBV infection (e.g. moderate to severe liver disease other than chronic HBV)
      • Co-infection with:
        • Current Hepatitis C infection or cured less than 12 months ago
        • HIV (human immunodeficiency virus)
        • Hepatitis D virus
      • Liver cirrhosis (diagnosed, suspected, or evidence of cirrhosis)
      • Diagnosed or suspected liver cancer (hepatocellular carcinoma)
      • History of certain cancers within the past 5 years
      • History or presence of vasculitis or autoimmune conditions
      • History of extrahepatic disorders possibly related to HBV immune conditions (e.g. kidney disorders, uncontrolled hypertension)

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      Based on the eligibility criteria, here are the key conditions you must meet to join this study:

      Inclusion Criteria:

      1. Documented chronic Hepatitis B virus (HBV) infection for at least 6 months prior to screening
        • Chronic HBV is a long-term infection of the liver by the hepatitis B virus
      2. Currently receiving stable nucleos(t)ide analogue (NA) therapy for at least 6 months with no planned changes
        • NAs are antiviral medications used to treat chronic HBV
      3. HBV surface antigen (HBsAg) level between 100 IU/mL and 3000 IU/mL
        • HBsAg is a protein on the surface of HBV and an indicator of active infection
      4. Suppressed HBV DNA level, defined as less than 90 IU/mL
        • HBV DNA is the genetic material of HBV, lower levels indicate treatment effectiveness
      5. Alanine aminotransferase (ALT) less than or equal to 2 times the upper limit of normal
        • ALT is a liver enzyme, elevated levels can indicate liver inflammation or damage
      6. Willingness and ability to cease NA treatment according to the study protocol

      The study has additional exclusion criteria related to other medical conditions and medications that are not listed here. Overall, the key requirements are having stable chronic HBV infection and meeting certain laboratory criteria.

      What Reasons Could Exclude Me from the Study?

      Below is a list of conditions that would exclude you from taking part in the study, along with explanations for the medical terms:

      1. Clinically significant abnormalities: Any serious health issues, except for chronic HBV infection, that are present in your medical history or during physical examination. This includes:
        1. Moderate to severe liver diseases other than chronic HBV.
        2. Acute coronary syndrome (a range of conditions associated with sudden, reduced blood flow to the heart) within 6 months of screening.
        3. Major surgery within 3 months of screening.
        4. Significant or unstable cardiac (heart) disease.
        5. Uncontrolled diabetes (when blood sugar levels are not properly managed).
        6. Bleeding diathesis or coagulopathy (disorders that affect the normal ability of blood to clot).
      2. Co-infection: If you have another infection at the same time as chronic hepatitis B, including:
        1. Hepatitis C infection currently or if cured, less than 12 months at the time of screening.
        2. Human immunodeficiency virus (HIV).
        3. Hepatitis D virus.
      3. History of or suspected liver cirrhosis: A condition where the liver is scarred and damaged, which can affect liver function.
      4. Diagnosed or suspected hepatocellular carcinoma: A type of liver cancer.
      5. History of malignancy within the past 5 years: Any cancer, except for specific types that are cured by surgery, such as certain skin cancers.
      6. History of vasculitis: Inflammation of blood vessels, or symptoms suggesting vasculitis, such as rash or skin ulcers.
      7. Autoimmune condition: Diseases where the body’s immune system attacks its own tissues, such as systemic lupus erythematosus or rheumatoid arthritis.
      8. Extrahepatic disorders related to HBV immune conditions: Conditions like nephrotic syndrome (kidney disorder) or types of glomerulonephritis (kidney inflammation), which may be associated with HBV.
      9. History of alcohol or drug abuse/dependence: Past or present serious misuse of alcohol or drugs.
      10. Immunosuppressing drugs: Medications like prednisone that lower the body’s ability to fight infections.
      11. Interferon therapy: Treatments containing interferon (a protein that modulates the response of the immune system) within 12 months prior to screening.
      12. Anti-coagulation therapies or anti-platelet agents: Medications that affect blood clotting, unless they can be safely discontinued for the study’s duration.
      13. Prior treatment with oligonucleotide or siRNA: Receiving these types of genetic or molecular therapies within 12 months before the first dosing day.
      14. Prior treatment with bepirovirsen: If you have already been treated with the investigational drug used in this study.

      These criteria are in place to ensure the safety of participants and the integrity of the study results.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. Bepirovirsen (active substance not explicitly provided): Bepirovirsen is an antisense oligonucleotide-based therapy, which suggests that it functions by binding to the RNA of the hepatitis B virus (HBV) and blocking its ability to replicate. This drug will be administered to participants in the experimental arm group.
      2. Placebo (no active substance): The placebo used in the study is presumably an inert substance designed to match the appearance and administration of Bepirovirsen, without containing any active therapeutic components. This is provided to participants in the comparator arm group.

      It is worth noting that while the specific active substance of Bepirovirsen is not provided in the text, the description of it as an oligonucleotide therapy points to its mechanism of action being targeted at the genetic material of the hepatitis B virus. Since a placebo does not contain an active substance, it does not require further description in terms of pharmacological action.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      Based on the information provided in the clinical trial description, the active substances participating in this trial are:

      1. Bepirovirsen: This appears to be an investigational drug being evaluated in the trial. As an experimental treatment, it is likely not well-established in medical literature yet, pending the results of trials like this one to demonstrate its efficacy and safety.
      2. Nucleos(t)ide analogues (NAs): These are a class of antiviral drugs used to treat hepatitis B. NAs are established treatments for chronic hepatitis B and are well-known in the medical literature. In this trial, participants will continue taking their current stable NA therapy.

      In summary, the trial involves one investigational drug (bepirovirsen) that is likely not yet well-described in medical literature, and an established class of hepatitis B drugs (NAs) that are known treatments covered extensively in the literature.


      Study ID

      CT-EU-00038050

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago

      Study phase

      Phase
      III

      Medicinal Product