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Clinical Trials for Hepatitis D

This article provides an overview of 11 ongoing clinical trials for Hepatitis D, a serious viral liver infection that occurs in people already infected with hepatitis B. These studies are evaluating new investigational treatments including brelovitug, bulevirtide, tobevibart, and elebsiran across multiple countries in Europe. The trials aim to assess how well these medications can reduce virus levels in the blood and improve liver health in people with chronic hepatitis D infection.

Clinical trial locations

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

This trial is comparing two medications for treating chronic hepatitis D infection: brelovitug (BJT-778) and bulevirtide. Both drugs work by preventing the virus from entering liver cells.

Main inclusion criteria: Participants must be at least 18 years old with confirmed chronic hepatitis D infection lasting at least 6 months. They need HDV RNA levels above 500 IU/mL and elevated liver enzyme levels. Participants must be taking or willing to take one of three hepatitis B medications: tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or entecavir, and continue this throughout the study.

Main exclusion criteria: People with advanced liver cirrhosis, liver tumors, HIV co-infection, or active hepatitis flare-ups cannot participate. Those who have previously been treated with bulevirtide or lonafarnib are excluded. Pregnant or breastfeeding women, people with uncontrolled high blood pressure, severe heart problems, recent cancer history, or recent drug or alcohol abuse are also excluded.

Study focus: The trial evaluates how effective brelovitug is compared to bulevirtide over a 48-week period. Researchers will monitor HDV RNA levels and liver enzyme levels to assess if the treatments can make the virus undetectable and normalize liver function. The study also tracks liver stiffness and quality of life. The entire study lasts 96 weeks, with the main comparison at week 48.

Investigational drugs: Brelovitug is an experimental medication being studied to reduce virus levels and potentially improve liver health. Bulevirtide is an approved medication that blocks the virus from entering liver cells, helping reduce liver inflammation and damage.

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

This study evaluates BJT-778, an investigational medication given as a subcutaneous injection, compared to a delayed treatment approach.

Main inclusion criteria: Participants must be at least 18 years old with confirmed chronic hepatitis delta infection for at least 6 months. HDV RNA levels must be greater than 500 IU/mL and liver enzyme (ALT) levels must be above normal at screening. Participants need to be taking or willing to start one of three medications: tenofovir disoproxil fumarate, tenofovir alafenamide fumarate, or entecavir, and continue throughout the trial.

Main exclusion criteria: The trial excludes people with other types of hepatitis infections, those outside the specified age range, vulnerable populations, and those unable to follow study procedures or attend required visits. People with other medical conditions that might interfere with study results are also excluded.

Study focus: The trial assesses the effectiveness of BJT-778 in managing the infection over time. Researchers will monitor changes in virus levels and liver function, with assessments at weeks 24, 48, and 96. The goal is to provide information on whether BJT-778 can be an effective treatment option.

Investigational drugs: BJT-778 (also known as brelovitug) is administered as a subcutaneous injection. It is being evaluated to see if it can help manage chronic hepatitis delta infection by reducing viral load and improving liver health.

Study on the Effects and Safety of Bulevirtide, Peginterferon Alfa-2a, and Entecavir in Patients with Chronic Hepatitis D

This trial evaluates bulevirtide treatment for chronic hepatitis D, with some participants receiving a placebo for comparison.

Main inclusion criteria: Participants must be over 18 years old with a diagnosis of chronic HBV/HDV co-infection and compensated liver disease. They must need treatment with bulevirtide or already be receiving it. Female participants must either be postmenopausal, surgically sterile, abstain from heterosexual intercourse, or use highly effective contraception. Male participants must also use effective contraception. All participants must provide written informed consent.

Main exclusion criteria: The specific exclusion criteria listed only mention that patients with hepatitis D cannot participate, which appears to be an error in the source data as the trial is specifically for hepatitis D patients.

Study focus: The study tracks virus levels in the blood and monitors liver health and overall well-being over time. Regular check-ups and tests ensure participant safety and gather data on the treatment’s impact. Follow-up visits continue at 3, 6, 9, and 12 months after treatment ends.

Investigational drugs: Bulevirtide is administered as a subcutaneous injection that blocks the hepatitis D virus from entering liver cells, helping reduce the amount of virus in the body.

Study on the Effects of Tobevibart and Elebsiran Compared to Bulevirtide for Patients with Chronic Hepatitis D Virus Infection

This trial compares a combination therapy of tobevibart and elebsiran against bulevirtide for treating chronic hepatitis D virus infection.

Main inclusion criteria: Participants must be adults aged 18 to 70 years with a positive HDV test for at least 6 months and specific virus levels at study start. They must have noncirrhotic or compensated cirrhotic liver disease at baseline. Body Mass Index must be between 18 and 40. Participants need to be on specific hepatitis B medications for at least 12 weeks or have very low HBV levels in the blood.

Main exclusion criteria: People without chronic HDV infection, those outside the age range, vulnerable populations, people unable to follow study procedures, those with interfering medical conditions, pregnant or breastfeeding women, recent clinical trial participants, people with substance abuse history, and those with allergies to study medications are excluded.

Study focus: The study evaluates how well the combination of tobevibart and elebsiran works compared to bulevirtide in reducing virus amounts and assessing safety. Participants receive treatments through subcutaneous injections and are monitored regularly. At certain points, there may be a planned treatment interruption to evaluate sustained virologic response.

Investigational drugs: Tobevibart is a monoclonal antibody designed to target specific parts of the virus. Elebsiran is a nucleic acid-based treatment working at the genetic level to interfere with virus replication. Bulevirtide is a protein-based treatment already used for managing HDV infection.

Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection

This study evaluates a combination treatment using tobevibart and elebsiran for chronic hepatitis D virus infection, comparing immediate treatment to delayed treatment.

Main inclusion criteria: Adult men and women aged 18 to 70 years with a positive HDV test for at least 6 months and specific virus levels at study start. Participants must have noncirrhotic or compensated cirrhotic liver disease and specific liver enzyme levels. Body Mass Index must be between 18 and 40. Participants need to be on certain hepatitis B medications for at least 12 weeks or have very low HBV levels.

Main exclusion criteria: People without chronic HDV infection, those outside the specified age range, and vulnerable populations are excluded.

Study focus: The trial assesses effectiveness and safety of the combination therapy through subcutaneous injections. Participants have regular check-ups to monitor health and virus response. The study monitors whether treatments can reduce virus amounts and improve liver function over several years, with participants observed at different intervals up to week 192.

Investigational drugs: Tobevibart is a monoclonal antibody designed to target the virus and reduce its effects. Elebsiran aims to fight the virus and improve liver health. Both are used in combination to evaluate their effectiveness and safety.

Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment

This trial investigates a combination of tobevibart and elebsiran for people with chronic HDV infection who have not responded well to previous bulevirtide treatment.

Main inclusion criteria: Adults aged 18 to 70 years with HDV RNA levels of at least 500 IU/mL at study start. Participants must have been receiving bulevirtide 2 mg subcutaneous injection once daily for at least 24 weeks before starting the study. They must have noncirrhotic or compensated cirrhotic liver disease and a Body Mass Index between 18 and 40. Participants need to be on specific hepatitis B therapy for at least 12 weeks or have very low HBV DNA levels.

Main exclusion criteria: People with different hepatitis infections, those outside the age range, people unwilling or unable to follow procedures, those with interfering medical conditions, pregnant or breastfeeding women, recent clinical trial participants, people with substance abuse history, and those with known allergies to study medications are excluded.

Study focus: The trial evaluates whether the combination therapy can reduce virus levels in participants who have not achieved viral suppression with bulevirtide alone. Participants receive treatments through subcutaneous injections and are monitored regularly with comprehensive evaluations at weeks 24, 48, and 96. Treatment may be systematically interrupted around week 96 to evaluate sustained response.

Investigational drugs: Tobevibart helps control the virus in people previously treated with bulevirtide. Elebsiran is used alongside tobevibart to help achieve a state where the virus is no longer actively affecting the body, with the combination evaluated for better results in controlling infection and improving liver health.

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

This trial studies the effects of BJT-778 on individuals with chronic hepatitis B and hepatitis D infections, which are viral liver infections that can lead to serious liver damage.

Main inclusion criteria: Participants must be able to provide written informed consent and be adults between 18 and 70 years of age. Body Mass Index must be between 18 and 40 kg/m². They must have chronic hepatitis B virus infection for at least 6 months with specific viral levels. Participants need to be taking certain hepatitis B medications for at least 2 months and willing to continue during the study. Females must be nonpregnant and nonlactating and use acceptable contraception. Males must also use contraception and agree not to donate sperm for at least 12 weeks after the last dose.

Main exclusion criteria: The exclusion criteria listed appear contradictory, as they state patients with chronic hepatitis B and D infections cannot participate, yet the trial is specifically for these conditions.

Study focus: The study begins with healthy volunteers to assess initial safety, followed by participants with chronic infections. Researchers collect data on health changes, how the body processes the drug, and its impact on the viruses. The study runs until early 2025 to provide insights into treatment effectiveness and safety.

Investigational drugs: BJT-778 is administered as an injection (either intravenous or subcutaneous) and is being tested to assess its safety and well-tolerated nature in healthy volunteers and people with chronic hepatitis B and D infections.

Study on Bulevirtide Treatment for Patients with Chronic Hepatitis D

This trial observes the long-term effects of bulevirtide on the progression of liver disease in individuals with chronic hepatitis D.

Main inclusion criteria: Participants must be at least 18 years old and diagnosed with chronic hepatitis D infection for at least 6 months, confirmed by medical records. They must be able to understand and sign a written consent form and willing to follow the visit schedule and study requirements. Specific cohorts have additional documentation requirements regarding previous study participation, liver tests, and treatment plans.

Main exclusion criteria: People with other hepatitis infections besides chronic hepatitis D, those who have had liver transplants, people with severe liver disease complications such as liver cancer, current participants in other clinical trials, those with alcohol or drug abuse history in the past year, people with severe heart problems, pregnant or breastfeeding women, people with uncontrolled diabetes, those with autoimmune diseases, and people with severe allergic reactions to similar medications are excluded.

Study focus: The trial monitors participants for liver-related events such as liver failure, liver cancer, or need for liver transplant. It tracks the percentage developing cirrhosis and any serious side effects during treatment. Participants are observed for up to 144 weeks to gather comprehensive data on treatment impact.

Investigational drugs: Bulevirtide is administered as a 2 mg subcutaneous injection that blocks virus entry into liver cells, helping reduce virus amounts, slow liver disease progression, and decrease risk of liver-related complications.

Study on the Effectiveness and Safety of JNJ-73763989 and Tenofovir Alafenamide in Patients with Hepatitis B and D Co-infection

This trial studies the treatment of people co-infected with hepatitis B and hepatitis D viruses using a combination of JNJ-73763989 and a nucleos(t)ide analog.

Main inclusion criteria: Participants can be male or female aged 18 to 65 years (or legal age of consent if higher). They should be medically stable based on physical exam, medical history, vital signs, and heart test. They must have chronic hepatitis B infection confirmed by positive HBsAg test and chronic hepatitis D infection confirmed by positive HDV antibody or RNA test. Specific virus levels are required depending on which part of the study participants join.

Main exclusion criteria: People with different types of liver infection, those outside the specified age range, people not in the specified clinical trial group, and vulnerable populations are excluded.

Study focus: The study evaluates whether the combination treatment can reduce hepatitis D virus amounts and improve liver health. Participants are randomly assigned to receive either study medication or placebo through subcutaneous injection combined with oral medication. Regular follow-up visits monitor health status, medication adherence, and side effects, with efficacy measured by virus level decline and liver enzyme monitoring.

Investigational drugs: JNJ-3989 is an investigational medication being studied for its potential to reduce hepatitis D virus levels when used in combination with a nucleos(t)ide analog, which helps control the hepatitis B virus.

Study on the Effects of RBD1016 and Tenofovir Alafenamide for Patients with Chronic Hepatitis D Infection

This trial tests RBD1016, a new treatment given as a subcutaneous injection, for people with chronic hepatitis D virus infection.

Main inclusion criteria: Participants must be willing to provide written informed consent and be between 18 and 65 years old. Females of childbearing potential must use effective contraception and cannot be pregnant or breastfeeding. Males must also use contraception. Body mass index must be between 18 and 35. Participants need documented evidence of HDV and HBV infection for at least 6 months and must not have liver cirrhosis as confirmed by FibroScan test.

Main exclusion criteria: People with serious health conditions, pregnant or breastfeeding women, recent clinical trial participants, those with allergies to study medication, people with substance abuse history, those unable to comply with procedures, people with mental health conditions affecting participation, liver transplant recipients, people with severe kidney disease, and those with uncontrolled diabetes are excluded.

Study focus: The trial evaluates how effective and safe RBD1016 is, comparing it to placebo. Participants receive regular injections and attend follow-up visits. The study also includes Vemlidy tablets taken orally. Throughout the study lasting until 2027, participants are monitored for health changes, including liver function and virus levels, to see if RBD1016 can reduce virus amounts and improve liver health.

Investigational drugs: RBD1016 is administered through subcutaneous injections and is being studied for its effectiveness in reducing HDV RNA levels, which indicate virus presence in the body.

Study on the Effects of VIR-2218 and VIR-3434 for Patients with Chronic Hepatitis D Infection

This trial evaluates two investigational therapies, VIR-2218 (elebsiran) and VIR-3434 (tobevibart), for chronic hepatitis D virus infection.

Main inclusion criteria: Participants must be at least 18 years old (or age of legal consent) and younger than 70 years. They must have chronic HBV infection confirmed by positive tests on two occasions at least 6 months apart and be on approved hepatitis B therapy for at least 12 weeks. They need specific HBsAg levels and positive HDV antibody tests for at least 6 months with specific HDV RNA levels. Liver enzyme levels must be above normal but less than five times normal. Body Mass Index must be between 18 and 40. Female and male participants must use effective contraception and meet specific pregnancy-related criteria.

Main exclusion criteria: People with serious health conditions, pregnant or breastfeeding women, those with allergic reaction history to similar medications, current clinical trial participants, people with substance abuse affecting study ability, those who received recent HDV treatments, and people with conditions doctors believe would make participation unsafe are excluded.

Study focus: The trial assesses effectiveness and safety of the combination therapy through subcutaneous injections. Participants have regular check-ups monitoring virus levels and liver health at different time points including weeks 12, 24, 48, 72, 96, 144, and 192. The study evaluates whether treatments can reduce virus amounts and improve liver function, monitoring for adverse effects throughout.

Investigational drugs: VIR-2218 contains elebsiran, a nucleic acid designed to reduce viral levels and potentially improve liver health. VIR-3434 contains tobevibart, a monoclonal antibody that targets the virus to help control its spread and impact on the liver.

Summary

The 11 clinical trials for hepatitis D show significant research activity concentrated in several European countries, with Romania, France, Germany, and Italy hosting the most trials. This geographical distribution likely reflects areas where the infection is more prevalent and where research infrastructure for viral hepatitis is well established.

Several investigational drugs feature prominently across multiple trials. Bulevirtide, which is already approved in Europe, appears in several studies evaluating its effectiveness and comparing it to newer treatments. The combination of tobevibart and elebsiran is being tested in multiple trials, both as a first-line treatment and for patients who have not responded to bulevirtide. BJT-778 (brelovitug) is another medication appearing in multiple studies.

Most trials require participants to be between 18 and 70 years old with confirmed chronic hepatitis D infection lasting at least six months. A common requirement across studies is that participants must be taking or willing to take medications for hepatitis B, as the hepatitis D virus requires hepatitis B to replicate. Common exclusion criteria include advanced liver disease, pregnancy, other serious medical conditions, and recent substance abuse.

The trials are evaluating various outcomes including reduction in virus levels, improvement in liver enzyme levels, changes in liver stiffness, and prevention of disease progression. Study durations vary, with some lasting 48 weeks and others extending to 96 weeks or longer, reflecting the chronic nature of the infection and the need for long-term safety and effectiveness data.

Ongoing Clinical Trials on Hepatitis D

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

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria France Romania

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