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Chronic hepatitis B – Trials in Disease

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Ongoing Clinical Trials for Chronic Hepatitis B

There are currently 18 clinical trials underway across Europe studying new treatments and approaches for chronic hepatitis B. These trials are investigating various medications including antiviral therapies, therapeutic vaccines, and immune-enhancing treatments, aiming to improve disease management and potentially achieve functional cures for this long-term liver infection.

Clinical trial locations

Long-term Study on Treatment Response in Chronic Hepatitis B Patients Using Bepirovirsen

This trial focuses on evaluating the long-term durability of treatment response in individuals who have previously been treated with bepirovirsen, a medication designed to target the hepatitis B virus. The study monitors participants over an extended period to assess how well the effects of bepirovirsen last after treatment has ended.

Main inclusion criteria: Participants must have documented chronic hepatitis B infection lasting at least six months and must have previously participated in a bepirovirsen treatment study. They need to have achieved specific treatment responses in their previous study, including reductions in HBsAg and HBV DNA levels. Those on stable nucleos(t)ide analogue therapy must be willing to stop this treatment according to the study schedule. All participants must be capable of providing informed consent.

Main exclusion criteria: The trial excludes individuals with other serious liver diseases besides chronic hepatitis B, those who have had liver transplants, pregnant or breastfeeding women, and those with a history of alcohol or drug abuse. Participants who cannot commit to the study schedule or have medical conditions that could interfere with study results may also be excluded.

Study focus: The trial aims to understand the durability of treatment response by monitoring HBsAg and HBV DNA levels in participants’ blood. Researchers will track any signs of viral rebound and the need for additional medication. The study will provide valuable information on maintaining long-term response to bepirovirsen treatment.

Investigational drug: Bepirovirsen is administered as a subcutaneous injection and works by targeting viral RNA to reduce hepatitis B virus replication. Nucleos(t)ide therapy, another treatment used in the study, helps control the infection by interfering with the virus’s ability to replicate.

Study on the Safety and Effectiveness of VIR-2218, VIR-3434, and Peginterferon Alfa-2a for Patients with Chronic Hepatitis B

This study explores the safety and effectiveness of a combination treatment approach using VIR-2218, VIR-3434, and peginterferon alfa-2a. The trial aims to find a treatment regimen that could lead to a functional cure, meaning the virus becomes undetectable in the blood and liver function normalizes.

Main inclusion criteria: Participants must be between 18 and 65 years old with a body mass index between 18 and 35. They need confirmed chronic hepatitis B infection for at least six months, shown by positive HBsAg tests. Participants must be on continuous NRTI therapy for at least two months before the study, with HBV DNA levels below 100 IU/mL. Besides having chronic hepatitis B, participants must be in good health based on medical examinations and lab tests. Women must have negative pregnancy tests, and both men and women must use effective contraception methods.

Main exclusion criteria: The study excludes pregnant or breastfeeding women, individuals with serious health conditions that could interfere with the study, those with allergic reactions to the study medications, and people currently using certain interfering medications. Individuals with recent clinical trial participation, alcohol or drug abuse history, or compromised immune systems are also excluded.

Study focus: The trial evaluates how well these treatments work together in achieving a functional cure and measures their impact on HBsAg and HBV DNA levels. Participants will receive treatment for up to 48 weeks and be monitored for 24 weeks after treatment ends to assess long-term effects.

Investigational drugs: VIR-2218 and VIR-3434 are new medications being tested, while peginterferon alfa-2a is an established treatment that boosts the immune system to fight the virus. All medications are given as subcutaneous injections.

Study on the Safety and Efficacy of a Hepatitis B Vaccine with Hepatitis B Surface Antigen (rDNA), MVA-HBVAC, and Mosaic HBcoreAg for Adults with Chronic Hepatitis B

This trial tests a therapeutic vaccine called TherVacB, which uses a combination approach to help the immune system fight hepatitis B more effectively. The vaccine aims to boost the body’s natural defenses against the virus.

Main inclusion criteria: Participants must be able to provide informed consent and have confirmed chronic hepatitis B infection for at least six months, with positive HBsAg and negative anti-HBs. HBsAg levels must be between 100-2000 IU/mL, and participants must be on HBV nucleos(t)ide analog treatment for at least six months with viral loads below 100 IU/mL. Participants must be between 18 and 70 years old and in good health apart from chronic hepatitis B. Women must have negative pregnancy tests, and both men and women must use effective contraception. Body mass index should be between 18.5 and 32.0 kg/m².

Main exclusion criteria: The study does not specify detailed exclusion criteria in the provided data, but generally excludes those who do not meet the strict health and eligibility requirements outlined in the inclusion criteria.

Study focus: The vaccine is administered as intramuscular injections, and the study monitors safety, tolerability, and immune response. Researchers will assess changes in HBsAg levels and monitor for any adverse reactions within seven days after each vaccination.

Investigational drug: TherVacB is a therapeutic vaccine that primes the immune system with a protein component and then boosts it with a modified virus called MVA, aiming to enhance the body’s ability to recognize and fight the hepatitis B virus.

Study on the Safety and Immune-Enhancing Effects of Pomalidomide in Patients with Chronic Hepatitis B Infection

This trial investigates pomalidomide, a medication that may enhance immune system response against the hepatitis B virus. The study aims to determine if pomalidomide is safe and can improve the body’s natural defenses against the infection.

Main inclusion criteria: Participants must be between 18 and 70 years old with chronic hepatitis B infection documented for more than six months through positive HBsAg tests. They can be either HBeAg positive or negative and must not be currently receiving nucleoside analogue treatment. All participants must provide informed consent and agree to use effective contraception. Males must use contraception or have documented vasectomy or azoospermia.

Main exclusion criteria: The trial excludes individuals without hepatitis B virus infection, those outside the specified age range, pregnant or breastfeeding women, and individuals considered part of vulnerable populations.

Study focus: The study monitors safety by observing side effects and assesses various health aspects including viral levels, liver function, and immune cell activity. The goal is to understand how pomalidomide affects the body and its potential benefits for managing chronic hepatitis B.

Investigational drug: Pomalidomide is taken orally in capsule form and is classified as an immunomodulatory drug, meaning it can alter immune responses to help the body fight infections more effectively.

Study comparing ALG-000184 with tenofovir disoproxil in untreated adults with chronic hepatitis B virus infection

This study compares a new experimental medication, ALG-000184, with an established treatment, tenofovir disoproxil, in adults who have not previously received treatment for hepatitis B. The trial aims to determine how effective the new medication is compared to standard treatment.

Main inclusion criteria: Participants must be between 18 and 65 years old with a body mass index between 18.0 and 35.0. They need to have chronic hepatitis B infection with HBsAg levels of 100 IU/mL or higher and HBV DNA levels of 20,000 IU/mL or higher. Liver enzyme levels must be no more than eight times the upper normal limit. Participants must either have never received hepatitis B treatment or not taken any medications for at least six months.

Main exclusion criteria: The study excludes individuals with a history of liver cancer, previous liver transplants, co-infections with HIV, hepatitis C, or hepatitis D, pregnant or breastfeeding women, active substance abuse, significant heart or kidney conditions, recent clinical trial participation, known allergies to study medications, severe liver disease or cirrhosis, abnormal blood test results, and autoimmune diseases.

Study focus: The 48-week treatment period includes regular monitoring through blood tests to measure virus levels, liver function tests, physical examinations, and heart monitoring. The study aims to evaluate viral control and overall safety of ALG-000184 compared to tenofovir disoproxil.

Investigational drugs: ALG-000184 is an experimental medication being tested as a new potential therapy. Tenofovir disoproxil fumarate is an established antiviral medication that prevents the hepatitis B virus from multiplying, serving as the active control treatment.

Study of Tenofovir Alafenamide for Children and Teens with Chronic Hepatitis B

This trial studies tenofovir alafenamide in children and adolescents aged 2 to under 18 years with chronic hepatitis B. The study aims to understand how safe and effective this medication is in reducing virus levels in young patients.

Main inclusion criteria: Participants must be between 2 and 17 years old with appropriate weight requirements for their cohort. For those 12 to under 18 years, weight must be at least 35 kg. Participants need documented chronic hepatitis B infection for at least six months with specific HBV DNA and ALT levels. Kidney function must be adequate with creatinine clearance of at least 80 mL/min/1.73m². Both treatment-naive participants and those with previous treatment experience are eligible.

Main exclusion criteria: The study excludes participants not diagnosed with chronic hepatitis B, those younger than two or older than 18 years, those weighing less than required, participants unable to take medication as prescribed, those with other serious health conditions, pregnant or breastfeeding participants, and those with recent clinical trial participation or allergic reactions to the study medication.

Study focus: The trial evaluates safety and effectiveness over 48 weeks with extended monitoring up to 240 weeks. Regular blood tests measure virus levels and liver function, with bone mineral density and kidney function tests at specified intervals.

Investigational drug: Tenofovir alafenamide is taken once daily and works by reducing hepatitis B virus amounts in the body, helping the immune system fight the infection and improving liver function.

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

This trial evaluates BJT-778, a new treatment for individuals with chronic hepatitis B and hepatitis D infections. The study begins with healthy volunteers before moving to people with these infections to assess safety and effects.

Main inclusion criteria: Participants must be adults aged 18 to 70 years with a BMI between 18 and 40 kg/m². They need chronic hepatitis B infection documented for at least six months with plasma HBV DNA levels below 100 IU/mL. Participants must be currently taking certain hepatitis B medications for at least two months and willing to continue during the study. Specific HBsAg level criteria vary by study group. Women must be non-pregnant and non-lactating with effective contraception use. Men must be surgically sterile or use contraception and agree not to donate sperm.

Main exclusion criteria: The study excludes patients with chronic hepatitis B and D infections from certain study phases. No participants with these conditions are eligible for initial phases focused on healthy volunteers.

Study focus: The trial monitors how the body processes the drug and its impact on the viruses. Participants receive BJT-778 injections either intravenously or subcutaneously with regular health monitoring throughout the study.

Investigational drug: BJT-778 is administered as a solution for injection and is being tested in early stages to ensure safety and to understand how it works in fighting hepatitis B and D viruses.

Study of Bepirovirsen for Patients with Chronic Hepatitis B on Nucleos(t)ide Analogue Treatment

This trial evaluates bepirovirsen in achieving a functional cure for individuals already receiving nucleos(t)ide analogue therapy. The study involves a 24-week treatment period with initial higher doses designed to achieve the desired treatment effect.

Main inclusion criteria: Participants must have documented chronic hepatitis B infection for at least six months and be receiving stable nucleos(t)ide analogue therapy with no changes for at least six months. HBsAg concentration must be between 100 and 3000 IU/mL, and HBV DNA levels must be adequately suppressed below 90 IU/mL. ALT levels must be no more than twice the upper limit of normal. Participants must be willing to stop NA treatment according to the study protocol.

Main exclusion criteria: The study excludes patients not on NA treatment, those with baseline HBsAg levels higher than 3000 IU/mL, participants outside the specified age range, and those considered part of vulnerable populations.

Study focus: The goal is to achieve a functional cure, meaning the virus is controlled without ongoing medication need. Participants are monitored for 24 weeks after stopping treatment without rescue medication to assess treatment success.

Investigational drug: Bepirovirsen is given as a subcutaneous injection and targets the virus to reduce viral levels or eliminate it altogether. The medication aims to help the immune system better control the infection.

Study of tenofovir disoproxil versus placebo for children aged 2-12 years with chronic hepatitis B infection

This trial investigates the effectiveness of tenofovir disoproxil fumarate in reducing hepatitis B virus amounts in children aged 2 to under 12 years. The study compares this medication against placebo over approximately four years.

Main inclusion criteria: Participants must be between 2 and 12 years old weighing at least 10 kg with chronic hepatitis B infection documented for at least six months. They need hepatitis B virus levels of at least 100,000 copies per milliliter and liver enzyme levels at least 1.5 times higher than normal. Good kidney function is required with creatinine clearance of at least 80 mL/min/1.73m². Adequate blood counts are necessary including appropriate neutrophil and hemoglobin levels. Participants must not have previously taken tenofovir DF, and females must have negative pregnancy tests.

Main exclusion criteria: The study excludes those with previous tenofovir treatment or other hepatitis B medications within specified timeframes, children younger than two or older than 12, those with active liver disease from other causes, known allergies to study medication, severe kidney problems, recent clinical trial participation, serious medical conditions, inability to take oral medication, HIV co-infection, liver cancer or cirrhosis history, pregnant or breastfeeding females, and mental conditions affecting study participation.

Study focus: The 192-week treatment period includes monitoring virus levels, liver function, bone density, and overall health. The study measures how many children achieve very low virus levels and improvements in liver function.

Investigational drug: Tenofovir disoproxil fumarate is an antiviral medication that blocks an enzyme the hepatitis B virus needs to multiply, helping reduce virus amounts in the body and prevent liver damage.

Study on Bepirovirsen for Patients with Chronic Hepatitis B Receiving Nucleos(t)ide Analogue Treatment

This trial evaluates bepirovirsen effectiveness and safety in achieving functional cure for individuals already receiving nucleos(t)ide analogue treatment. The study includes a 24-week treatment period with loading doses to achieve desired effects.

Main inclusion criteria: Participants must have documented chronic hepatitis B infection for at least six months before screening and be currently receiving stable NA therapy with no changes for at least six months. HBV DNA levels must be adequately suppressed below 90 IU/mL, and HBsAg concentration must be between 100 and 3000 IU/mL. ALT levels must be no more than twice the upper limit of normal. Participants must be willing to stop NA treatment according to study protocol.

Main exclusion criteria: The study excludes individuals with hepatitis B not on NA treatment, those with baseline HBsAg levels greater than 3000 IU/mL, participants outside specified age range, and those considered part of vulnerable populations.

Study focus: The study aims to determine if bepirovirsen can achieve functional cure with the virus controlled without ongoing medication. The primary endpoint is maintaining functional cure for 24 weeks after stopping all chronic hepatitis B treatments without rescue medication.

Investigational drug: Bepirovirsen is administered as subcutaneous injection for 24 weeks with initial higher doses. It is designed to reduce viral levels in the body and is classified as an antisense oligonucleotide targeting viral RNA.

Study on Safety and Efficacy of Bepirovirsen and Drug Combination for Chronic Hepatitis B in Patients on Nucleos(t)ide Analogue Therapy

This trial studies a sequential treatment approach using GSK3228836 (an anti-sense oligonucleotide) followed by GSK3528869A (a targeted immunotherapy) for patients already receiving nucleos(t)ide analogue therapy. The study evaluates safety and effectiveness of this combination approach.

Main inclusion criteria: Participants must be 18 to 65 years old (19 to 65 in South Korea) and able to follow study requirements including completing diary cards and attending follow-up visits. They need documented chronic HBV infection for at least six months with stable NA therapy for at least six months before screening. Participants must be receiving treatment with NA that has high resistance barrier such as entecavir or tenofovir. ALT levels must be no more than twice the upper limit of normal, HBsAg concentration must exceed 100 IU/mL, and HBV DNA must be adequately suppressed below 90 IU/mL. Both men and women must use effective contraception.

Main exclusion criteria: The study excludes individuals without stable chronic hepatitis B condition while on NA therapy, those outside specified age range, people who are part of vulnerable populations, and those not meeting gender requirements.

Study focus: The initial phase involves GSK3228836 administration through subcutaneous injection, followed by GSK3528869A through intramuscular injection. Regular monitoring assesses side effects and overall health with final evaluation expected by February 2026.

Investigational drugs: GSK3228836 is an anti-sense oligonucleotide designed to reduce virus levels by interfering with viral replication. GSK3528869A is targeted immunotherapy aiming to boost immune response against hepatitis B virus. Both are used sequentially with existing nucleos(t)ide analogue therapy.

Summary

The 18 ongoing clinical trials for chronic hepatitis B represent a diverse range of treatment approaches across multiple European countries. The trials show notable concentration in Romania, which hosts 10 trials, followed by France, Italy, Spain, Germany, Bulgaria, and Poland, each hosting between 6-9 trials. Belgium, Greece, Hungary, Denmark, Netherlands, and Sweden each host between 1-3 trials.

Bepirovirsen stands out as the most frequently studied medication, appearing in seven separate trials. This investigational drug is being evaluated both as monotherapy and in combination with other treatments, with multiple trials focusing on patients already receiving nucleos(t)ide analogue therapy. Several trials aim to achieve what researchers call a “functional cure,” where the virus becomes controlled without ongoing medication.

The trials include studies targeting different age groups, from children as young as two years old to adults up to 75 years. Two trials specifically focus on pediatric populations, studying tenofovir-based treatments in children and adolescents.

Treatment approaches vary widely, including traditional antiviral medications, therapeutic vaccines, immune-enhancing drugs, and novel combination therapies. Some trials explore sequential treatment strategies, where one medication is given followed by another to potentially enhance effectiveness.

Most trials require participants to have documented chronic hepatitis B infection for at least six months and maintain specific viral load and liver enzyme levels. Many studies focus on patients already receiving standard nucleos(t)ide analogue therapy, investigating whether new treatments can improve outcomes beyond current standard care.

Ongoing Clinical Trials on Chronic hepatitis B

  • Study comparing ALG-000184 with tenofovir disoproxil in untreated adults with chronic hepatitis B virus infection

    Recruiting

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

  • A study to evaluate the safety and effectiveness of MRNA3771 and GRNA1599 in adults with chronic hepatitis B

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on the Safety and Efficacy of a Hepatitis B Vaccine with Hepatitis B Surface Antigen (rDNA), MVA-HBVAC, and Mosaic HBcoreAg for Adults with Chronic Hepatitis B

    Recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

  • Study of Tenofovir Alafenamide for Children and Teens with Chronic Hepatitis B

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Romania

  • Study of Bepirovirsen for Patients with Chronic Hepatitis B on Nucleos(t)ide Analogue Treatment

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Germany Greece Hungary Italy +3

  • Study of GSK3965193 and Bepirovirsen for People Living with Chronic Hepatitis B Infection and Healthy Participants

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    France Italy

  • Study on Stopping Tenofovir Alafenamide, Tenofovir Disoproxil, and Entecavir in Patients with Chronic Hepatitis B

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Study on the Safety and Effectiveness of Terbinafine for Patients with Chronic Hepatitis B

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on the Safety and Effectiveness of VIR-2218, VIR-3434, and Peginterferon Alfa-2a for Patients with Chronic Hepatitis B

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Romania

  • Study of tenofovir disoproxil versus placebo for children aged 2-12 years with chronic hepatitis B infection

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Romania

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