Ongoing Clinical Trials for Hepatitis B
Currently, there are 5 clinical trials investigating new treatments for Hepatitis B. These studies are testing various medications designed to help control the virus and improve liver health. Some trials focus on people who also have HIV or Hepatitis D co-infections, while others examine treatments for those who haven’t responded well to existing therapies. The trials are being conducted across several European countries.
Clinical trial locations
- Austria
- Bulgaria
- France
- Study on Bepirovirsen for Patients with HIV and Chronic Hepatitis B on Antiretroviral Treatment
- Study on the Effectiveness and Safety of JNJ-73763989 and Tenofovir Alafenamide in Patients with Hepatitis B and D Co-infection
- Study on the Effects of VIR-2218 and VIR-3434 for Patients with Chronic Hepatitis D Infection
- Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection
- Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment
- Germany
- Study on the Effects of VIR-2218 and VIR-3434 for Patients with Chronic Hepatitis D Infection
- Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection
- Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment
- Italy
- Study on Bepirovirsen for Patients with HIV and Chronic Hepatitis B on Antiretroviral Treatment
- Study on the Effectiveness and Safety of JNJ-73763989 and Tenofovir Alafenamide in Patients with Hepatitis B and D Co-infection
- Study on the Effects of VIR-2218 and VIR-3434 for Patients with Chronic Hepatitis D Infection
- Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment
- Netherlands
- Romania
- Study on the Effects of VIR-2218 and VIR-3434 for Patients with Chronic Hepatitis D Infection
- Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection
- Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment
- Spain
- Sweden
Study on Bepirovirsen for Patients with HIV and Chronic Hepatitis B on Antiretroviral Treatment
This trial is examining a medication called Bepirovirsen for people living with both HIV and chronic Hepatitis B infection. The study compares Bepirovirsen to a placebo to assess its effectiveness and safety.
Main inclusion criteria: Participants must have documented chronic Hepatitis B and HIV infections for at least 12 months. They need to be on stable antiretroviral treatment containing specific medications such as Tenofovir disoproxil or Tenofovir alafenamide plus Lamivudine or Emtricitabine for more than 12 months. HIV RNA levels must be undetectable, and HBV DNA levels must be adequately suppressed. The CD4 count must be 350 cells per cubic millimeter or higher, and liver enzyme levels should be no more than twice the upper normal limit.
Main exclusion criteria: People without both HIV and Hepatitis B infections cannot participate. Participants must be on active antiretroviral treatment and have baseline HBV surface antigen levels of 3000 IU/mL or less. Those outside the specified age range or who do not meet gender criteria are excluded.
Focus of the trial: The study aims to determine if Bepirovirsen can achieve undetectable levels of Hepatitis B surface antigen and HBV DNA 36 weeks after completing 24 weeks of treatment. Participants will continue their regular HIV treatment while receiving the study medication through injections. This is a double-blind study, meaning neither participants nor researchers know who receives the active medication.
Investigational drug: Bepirovirsen is given as a solution for injection and targets the Hepatitis B virus at the molecular level to reduce its presence in the body.
Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection
This trial evaluates a combination treatment using Tobevibart and Elebsiran for people with chronic Hepatitis D Virus infection. Both medications are given as injections under the skin.
Main inclusion criteria: Participants must be adults aged 18 to 70 years with a positive test for Hepatitis D Virus for at least 6 months and a certain level of the virus in the blood at the study start. They must have liver disease that is either not severe or is stable. A specific liver enzyme level is required, along with a Body Mass Index between 18 and 40. Participants must be on certain Hepatitis B medications for at least 12 weeks or have very low HBV levels in the blood.
Main exclusion criteria: People without chronic Hepatitis D Virus infection or those outside the specified age range cannot participate. Vulnerable populations are also excluded.
Focus of the trial: The study compares immediate treatment versus delayed treatment to assess the effectiveness and safety of the combination therapy. Participants will have regular check-ups to monitor virus levels and liver health over several years. The goal is to reduce the amount of virus in the body and improve liver function.
Investigational drugs: Tobevibart is a monoclonal antibody designed to target specific parts of the virus, while Elebsiran interferes with the virus’s ability to replicate.
Study on Tobevibart and Elebsiran for Patients with Chronic Hepatitis D Virus Infection Not Responding to Bulevirtide Treatment
This study investigates the combination of Tobevibart and Elebsiran specifically for people with chronic Hepatitis D who have previously been treated with Bulevirtide but have not achieved the desired results.
Main inclusion criteria: Adults aged 18 to 70 years must have HDV RNA levels of at least 500 IU/mL at the study start. They must have been receiving Bulevirtide 2 mg as a daily subcutaneous injection for at least 24 weeks before the study begins. Participants should have either non-cirrhotic or compensated cirrhotic liver disease and a Body Mass Index between 18 and 40. They must also be on specific Hepatitis B medications for at least 12 weeks or have very low HBV DNA levels.
Main exclusion criteria: People with other types of hepatitis infections, those outside the specified age range, pregnant or breastfeeding individuals, those with known allergies to study medications, and those with recent substance abuse history cannot participate.
Focus of the trial: The study aims to evaluate whether the combination therapy can better control the virus in people who still have it in their system despite previous treatment. Regular monitoring includes blood tests to measure virus levels and liver function. The goal is to achieve a state where the virus is no longer actively affecting the body and to improve liver health.
Investigational drugs: Tobevibart and Elebsiran are both administered through injections and work by targeting different aspects of the virus to prevent it from multiplying and causing damage.
Study on the Effectiveness and Safety of JNJ-73763989 and Tenofovir Alafenamide in Patients with Hepatitis B and D Co-infection
This trial focuses on treating people co-infected with both Hepatitis B and Hepatitis D viruses using a combination of JNJ-73763989 and a nucleos(t)ide analog medication.
Main inclusion criteria: Participants can be male or female, aged 18 to 65 years. They must be medically stable based on physical examination, medical history, vital signs, and heart tests. Participants must have chronic Hepatitis B infection confirmed by a positive HBsAg test and chronic Hepatitis D infection confirmed by positive HDV antibodies or HDV RNA. Specific virus level requirements vary between different parts of the study.
Main exclusion criteria: People with different types of liver infections other than Hepatitis B and D, those outside the specified age range, and vulnerable populations cannot participate.
Focus of the trial: The study evaluates the effectiveness and safety of the combination treatment by monitoring changes in virus levels and liver health. Participants will receive either the new treatment or a placebo in a double-blind setting. Regular check-ups and tests will track progress throughout the study period. The aim is to see if the combination can reduce the Hepatitis D virus amount and improve liver health.
Investigational drugs: JNJ-73763989 is given as a subcutaneous injection combined with an oral nucleos(t)ide analog. JNJ-73763989 targets and reduces viral protein production, inhibiting virus replication.
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 and VIR-3434, for people with chronic Hepatitis D Virus infection. Both medications are administered through injections under the skin.
Main inclusion criteria: Participants must be at least 18 years old and younger than 70 years at screening. They must have chronic HBV infection confirmed by positive virus markers on two occasions at least 6 months apart and have been on approved Hepatitis B medication for at least 12 weeks before the study. Specific blood levels of HBsAg, HDV antibodies, and HDV RNA are required. Liver enzyme levels must be above normal but less than five times the normal limit. Body Mass Index must be between 18 and 40. Women of childbearing potential must have negative pregnancy tests and agree to use effective contraception, while male participants must also agree to contraception methods.
Main exclusion criteria: People with serious health conditions that might interfere with the study, pregnant or breastfeeding individuals, those with allergic reactions to similar medications, current participants in other trials, those with substance abuse history, or those who received recent HDV treatments cannot participate.
Focus of the trial: The study aims to assess how effective and safe these treatments are in reducing virus levels and improving liver function. Participants will have regular check-ups at various time points up to week 192 to track changes in their health and monitor for side effects.
Investigational drugs: VIR-2218 contains elebsiran, a nucleic acid that targets and degrades viral RNA to inhibit virus replication. VIR-3434 contains tobevibart, a monoclonal antibody that binds to viral particles, preventing them from entering liver cells. Both are antiviral agents designed to help control chronic HDV infection.
Summary
These five clinical trials represent important research efforts to develop better treatments for Hepatitis B and related co-infections. A notable observation is that three of the five trials focus specifically on chronic Hepatitis D co-infection, highlighting the significant unmet medical need for this patient population. France appears most frequently as a trial location, hosting all five studies, followed by Italy, Germany, and Romania. Several trials are investigating combination therapies using Tobevibart and Elebsiran, suggesting these medications are a major focus of current research. Additionally, one trial specifically targets people living with both HIV and Hepatitis B, recognizing the unique challenges of managing multiple viral infections simultaneously. All studies emphasize careful monitoring of liver health and virus levels throughout treatment, reflecting the importance of tracking both safety and effectiveness over time.
