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Study on the Safety and Effects of RBD1016 Injection for Patients with Chronic Hepatitis B on Nucleoside Analogues Treatment

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 chronic hepatitis B, a long-term infection of the liver caused by the hepatitis B virus. The trial will evaluate a new treatment called RBD1016 Injection, which is a type of medication known as a siRNA oligonucleotide. This treatment is designed to be given as an injection under the skin and is being tested to see how safe and effective it is for people with chronic hepatitis B who are already receiving standard treatment with medications called nucleoside analogues.

The purpose of the study is to assess the safety and effectiveness of the RBD1016 Injection when used alongside existing treatments. Participants in the study will be randomly assigned to receive either the RBD1016 Injection or a placebo, which looks like the treatment but does not contain the active substance. The study will be conducted in a way that neither the participants nor the researchers know who is receiving the actual treatment or the placebo, ensuring unbiased results. The study will include a screening period to determine eligibility, a treatment period where the injections are given, and a follow-up period to monitor participants' health and response to the treatment.

Participants will be divided into three groups, each receiving different doses of the RBD1016 Injection. The study will monitor the participants for any side effects and measure how well the treatment works in reducing the levels of the virus in the body. The trial aims to provide valuable information on the potential benefits and risks of using RBD1016 Injection for treating chronic hepatitis B, contributing to the development of new treatment options for this condition.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Screening period
During the screening period, eligibility for the trial is assessed. This involves checking medical history and current health status. Tests may include blood tests and liver scans to ensure the liver stiffness measurement is less than 9 kPa or a liver biopsy showing a Metavir score of F0-F2.
Participants must be aged 18-65 years, have a body mass index (BMI) between 18-34 kg/m², and have a documented history of chronic hepatitis B infection. Females must not be pregnant or lactating and must use effective contraception. Males must agree to use contraception to ensure effective contraception for their partners.
Step 2
Treatment period
The treatment period involves receiving the study medication, RBD1016 injection, or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.
Participants are divided into three groups: one group receives 100 mg every 4 weeks, another group receives 200 mg every 4 weeks, and the last group receives 200 mg every 12 weeks. The treatment continues for a specified duration as part of the trial.
Step 3
Follow-up period
After the treatment period, there is a follow-up period to monitor health and any effects of the treatment. This period lasts up to 24 weeks.
During this time, regular check-ups and tests are conducted to assess the safety and effectiveness of the treatment. The primary focus is on monitoring any adverse events and changes in hepatitis B surface antigen levels.

Who can join the trial?

12 criteria

Willing and able to give written informed consent for trial participation.
Male or female participants aged 18-65 years.
Body mass index (BMI) within the range of 18-34 kilograms per square meter (kg/m²).
Documented history of chronic hepatitis B virus (HBV) infection, shown by positive HBsAg and/or HBV DNA tests for at least 6 months before screening.
HBeAg positive or negative at screening. (HBeAg is a protein from the hepatitis B virus.)
On a stable regimen (at least 12 months before screening) of any approved first-line oral nucleoside analogues (NAs). (These are medications used to treat hepatitis B.)
HBV DNA level less than 100 IU/mL at screening. (This measures the amount of hepatitis B virus in the blood.)
HBsAg level at least 50 IU/mL at screening. (HBsAg is a surface antigen of the hepatitis B virus.)
Serum/plasma alanine aminotransferase (ALT) less than or equal to 1.5 times the upper limit of normal (ULN). (ALT is an enzyme that helps diagnose liver health.)
Liver transient elastography (FibroScan) results within 12 months before screening or at screening showing that the liver stiffness measurement (LSM) level is less than 9 kPa; or with liver biopsy within 24 months before screening showing that the Metavir score is F0-F2. (These tests assess liver health and fibrosis.)
For females with child-bearing potential: must be non-pregnant and non-lactating; the participant is using a highly effective contraceptive method for at least one month before screening and agrees to use contraception during the trial period.
For males with child-bearing potential: the participant agrees to use contraception to ensure effective contraception for his sexual partner during the trial period.

Who cannot join the trial?

4 criteria

Patients who are not already receiving treatment with nucleoside analogues (NAs) cannot participate. Nucleoside analogues are a type of medication used to treat viral infections like hepatitis B.
Patients who are not diagnosed with chronic hepatitis B (CHB) cannot participate. Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus.
Patients who are not within the specified age range for the study cannot participate. The study includes specific age groups.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special protection in research settings.

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Verified sites

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Verified
CTC Clinical Trial Consultants AB
Uppsala, Sweden
Verified
Karolinska University Hospital
Solna, Sweden

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Investigated drugs

RBD1016 is an experimental medication being tested in this clinical trial. It is given as an injection and is being studied to see if it is safe and effective for people with chronic hepatitis B. The trial is looking at how well this medication works when used together with other treatments that people with hepatitis B might already be taking. The study is also checking how the body processes the medication and if it causes any immune reactions.

Rbd1016

What is already known about the treatment

RBD1016 – RBD1016 is administered as an injection and is currently being studied in a phase II clinical trial for its safety and effectiveness in treating chronic hepatitis B. This medication is being tested in combination with existing nucleoside analogues, which are standard treatments for this condition. The trial involves different dosing schedules to determine the best approach for patients. RBD1016 is part of ongoing research and is not yet widely available in medical practice.

Investigated diseases

Chronic hepatitis B – Chronic hepatitis B is a long-term infection of the liver caused by the hepatitis B virus. It begins with an acute phase, which may or may not present symptoms, and can progress to a chronic state if the virus remains in the body for more than six months. Over time, the virus can cause inflammation and damage to liver cells, leading to liver fibrosis or scarring. As the disease progresses, it can result in more severe liver damage, such as cirrhosis, where the liver becomes severely scarred and loses its ability to function properly. The disease can also lead to liver failure, where the liver can no longer perform its vital functions. Chronic hepatitis B can remain stable for many years, but it requires monitoring to manage potential complications.