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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called Pomalidomide in people with chronic hepatitis B virus (HBV) infection. Hepatitis B is a liver infection caused by the hepatitis B virus, which can become a long-term condition if the virus remains in the body for more than six months. The purpose of the study is to determine the safety of Pomalidomide in individuals with this chronic infection and to explore its potential to enhance the immune system's response to the virus.

Participants in the study will receive Pomalidomide in the form of a capsule taken orally. The study will monitor the safety of the medication by observing any side effects that may occur during the treatment. Additionally, the study will assess various aspects of the participants' health, such as the levels of the virus in the blood, liver function, and the activity of certain immune cells. These assessments will help researchers understand how Pomalidomide affects the body and its potential benefits for people with chronic hepatitis B.

The study is expected to take place over several years, with an estimated completion date in 2026. Participants will be closely monitored throughout the study to ensure their safety and to gather important data on the effects of Pomalidomide. This research aims to provide valuable insights into new treatment options for individuals living with chronic hepatitis B.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study's purpose and procedures.
You will need to confirm that you meet the eligibility criteria, such as being between 18 and 70 years old and having chronic hepatitis B virus (HBV) infection for more than six months.
Step 2
Initial screening
During the initial screening, a series of tests will be conducted to ensure you meet all the study requirements. This includes checking your HBV status and other health parameters.
If you are a female of child-bearing potential, a pregnancy test will be conducted to confirm eligibility.
Step 3
Medication administration
You will be given a medication called pomalidomide, which comes in the form of a capsule. This medication is taken orally.
The dosage, frequency, and duration of administration will be explained to you by the study team. It is important to follow the instructions carefully.
Step 4
Regular monitoring
Throughout the study, regular monitoring will be conducted to assess your health and the effects of the medication. This includes blood tests to measure levels of HBV DNA and other markers.
You will be monitored for any side effects or adverse events related to the medication. It is important to report any changes in your health to the study team.
Step 5
Follow-up visits
You will have scheduled follow-up visits with the study team. These visits are important to track your progress and make any necessary adjustments to your treatment.
During these visits, additional tests may be conducted to evaluate your response to the medication and overall health.
Step 6
End of study
At the end of the study, a final assessment will be conducted to evaluate the overall effects of the medication on your health.
You will receive information about any further steps or recommendations based on the study's findings.

Who can join the trial?

8 criteria

Must have evidence of chronic Hepatitis B virus (HBV) infection, which means testing positive for the Hepatitis B surface antigen (HBsAg) for more than 6 months.
Must be between the ages of 18 and 70 years old.
Can be either HBeAg positive or negative at the time of screening. HBeAg is a protein associated with the Hepatitis B virus.
Must not be currently receiving treatment with nucleoside analogues, which are a type of medication used to treat viral infections.
Must be able and willing to provide informed consent, meaning you understand the study and agree to participate.
If female, must either be of non-child-bearing potential (such as post-menopausal or having had surgery to prevent pregnancy) or, if of child-bearing potential, must have a negative pregnancy test and agree to use effective contraception methods during the study and for at least 2 weeks after.
All participants must agree not to try to become pregnant or impregnate someone else during the study. This includes not donating sperm or eggs.
If male and sexually active with a female partner, must agree to use effective contraception methods or have anatomical sterility (such as a vasectomy) during the study and for at least 4 weeks after stopping the study drug.

Who cannot join the trial?

4 criteria

People who do not have a Hepatitis B virus infection cannot participate.
Individuals who are not within the specified age range cannot participate. The study is open to certain age groups only.
Participants must be either male or female, as the study includes both genders.
Individuals who are considered part of a vulnerable population cannot participate. This means people who might need special protection or care.

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Region Midtjylland
Responsive
Aarhus, Denmark

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Investigated drugs

Pomalidomide is a medication being studied for its potential benefits in people with chronic hepatitis B virus (HBV) infection. It is known to have effects on the immune system, which means it might help the body fight infections more effectively. In this clinical trial, researchers are looking at how safe pomalidomide is for people with chronic HBV and whether it can enhance the immune response against the virus. The goal is to see if this medication can be a helpful addition to the treatment options for people living with chronic hepatitis B.

Pomalidomide

What is already known about the treatment

Pomalidomide – Pomalidomide is taken orally in the form of a capsule. It is currently being studied for its safety and potential to boost the immune system in people with chronic hepatitis B virus infection. The main therapeutic use being explored is for hepatitis B, a liver infection caused by the hepatitis B virus. At the molecular level, pomalidomide works by modulating the immune system, which may help the body fight infections more effectively. It is classified as an immunomodulatory drug, meaning it can alter the immune response.

Investigated diseases

Hepatitis B virus infection – Hepatitis B virus infection is a liver infection caused by the hepatitis B virus (HBV). It can be acute, lasting a few weeks, or chronic, persisting for a lifetime. The virus attacks liver cells, leading to inflammation and potential liver damage. In chronic cases, the infection can progress over time, causing liver fibrosis or cirrhosis. The immune system's response to the virus can vary, influencing the severity and progression of the disease. Symptoms may include jaundice, fatigue, abdominal pain, and dark urine, but some individuals may remain asymptomatic.