Not recruitingRare disease

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

Verified siteRegistered drugNo 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 a disease called chronic hepatitis D virus infection, which affects the liver. The trial will test a new treatment called RBD1016, which is given as an injection under the skin. The purpose of the study is to evaluate how effective and safe RBD1016 is for people with this condition. Participants in the study will receive either the new treatment or a placebo, which is a solution that looks like the treatment but does not contain the active substance.

The study will take place over a period of time, during which participants will receive regular injections and attend follow-up visits. The trial will also include a medication called Vemlidy, which is a tablet taken by mouth and is already used to treat certain viral infections. Throughout the study, participants will be monitored for any changes in their health, including their liver function and the levels of the virus in their blood.

Participants will be asked to attend regular appointments to check their health and the effects of the treatment. The study aims to see if RBD1016 can reduce the amount of the virus in the body and improve liver health. The trial will also look at how the body processes the treatment and whether it causes any side effects. The results will help determine if RBD1016 could be a new option for treating chronic hepatitis D virus infection.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial Treatment Phase
Upon joining the trial, the participant will begin receiving RBD1016 through subcutaneous injections. This medication is administered to evaluate its effectiveness in reducing the levels of the hepatitis D virus in the body.
The injections are given at regular intervals as determined by the trial protocol. The exact frequency and dosage will be communicated during the trial.
Step 2
Oral Medication Phase
In addition to the injections, the participant will take Vemlidy 25 mg film-coated tablets orally. This medication is used to manage hepatitis B virus infection, which often co-occurs with hepatitis D.
The tablets are taken once daily, and the duration of this treatment will be specified during the trial.
Step 3
Monitoring and Evaluation
Throughout the trial, the participant's health and response to the treatment will be closely monitored. This includes regular blood tests to measure the levels of the virus and assess liver function.
The participant will also undergo physical examinations and provide information on any side effects experienced during the trial.
Step 4
End of Trial Assessment
At the end of the trial, which is expected to last until 2027, a final assessment will be conducted. This will include a comprehensive evaluation of the participant's health and the effectiveness of the treatment.
The primary goal is to determine the reduction in hepatitis D virus levels and any improvements in liver function.

Who can join the trial?

10 criteria

Willing and able to give written informed consent to participate in the trial.
Female participants who can have children must agree to avoid pregnancy by either not having heterosexual intercourse (if this is their usual lifestyle) or using a very effective birth control method. This should be done from at least 2 weeks before the first trial medication to 4 weeks after the last dose. Effective methods include certain hormonal contraceptives or devices placed inside the uterus.
Female participants who cannot have children are those who have had certain surgeries or are post-menopausal (no periods for 12 months). In some cases, a blood test may be needed to confirm menopause.
Male participants must agree to avoid fathering a child by either not having heterosexual intercourse (if this is their usual lifestyle) or using condoms from the first dose of the trial medication until 3 months after the last dose.
Participants must be between 18 and 65 years old.
Participants must have a body mass index (BMI) between 18 and 35. BMI is a measure of body fat based on height and weight.
Participants must have documented evidence of infection with the hepatitis D virus (HDV) in their medical history, shown by positive test results for HDV antibodies or HDV RNA at least 6 months before screening.
Participants must have documented evidence of infection with the hepatitis B virus (HBV) in their medical history, shown by positive test results for HBsAg or HBV DNA at least 6 months before screening.
Participants must not have liver cirrhosis, which is a severe liver condition. This is confirmed by a specific test called FibroScan® elastography, showing a result less than 10 kPa at screening.
Female participants who can have children must have a negative pregnancy test at screening and when confirming eligibility. If the initial urine test is positive, a blood test will be done to confirm.

Who cannot join the trial?

10 criteria

Participants with any other serious health condition that might interfere with the study.
Individuals who are pregnant or breastfeeding.
People who have participated in another clinical trial recently.
Anyone with a known allergy to the study medication.
Individuals with a history of substance abuse.
Participants who are unable to comply with the study procedures.
Anyone with a mental health condition that might affect their ability to participate.
Individuals with a history of liver transplant.
People with severe kidney disease.
Participants with uncontrolled diabetes.

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Verified sites

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Verified
Danderyds Sjukhus AB
Danderyd, Sweden
Verified
Karolinska University Hospital
Solna, Sweden

Trial locations

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Investigated drugs

RBD1016 is a medication being studied for its effectiveness in treating chronic hepatitis D virus infection. It is administered through subcutaneous injections, which means it is injected under the skin. The main goal of the trial is to see how well this medication can reduce the levels of the hepatitis D virus in the body.

What is already known about the treatment

RBD1016 – This medication is administered through subcutaneous injections, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness in treating chronic hepatitis D virus infection. The main therapeutic indication for RBD1016 is to reduce the levels of HDV RNA in patients, which is a marker of the virus's presence in the body. At the molecular level, RBD1016 works by targeting specific pathways involved in the replication of the hepatitis D virus, thereby inhibiting its ability to multiply. It is classified pharmacologically as an antiviral agent.

Investigated diseases

Chronic Hepatitis D Virus Infection – This is a long-term infection caused by the hepatitis D virus, which only occurs in individuals who are also infected with the hepatitis B virus. The disease primarily affects the liver, leading to inflammation and potential liver damage over time. It is characterized by the presence of the virus in the blood and can result in symptoms such as fatigue, jaundice, and abdominal pain. The progression of the disease can vary, with some individuals experiencing mild symptoms while others may develop more severe liver complications. The infection is typically spread through contact with infected blood or bodily fluids. Managing the condition often involves monitoring liver function and addressing any complications that arise.