Imdusiran for Chronic Hepatitis B
(i-LIVER Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called Imdusiran (also known as AB-729) to evaluate its effects in the liver of people with chronic hepatitis B. Researchers aim to determine if Imdusiran can effectively target the hepatitis B virus. Participants will receive injections of Imdusiran every 8 weeks and undergo two liver biopsies to assess its effects. Those who have had hepatitis B for at least 6 months and are already on antiviral medication might be suitable candidates for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial requires that you continue taking your current hepatitis B oral antiviral medications throughout the study.
Is there any evidence suggesting that Imdusiran (AB-729) is likely to be safe for humans?
Research shows that Imdusiran (AB-729) is generally safe and well-tolerated. Previous studies found that participants experienced few serious side effects. These studies tested both single and multiple doses, and the treatment still showed good safety results. Most participants did not have severe negative reactions. However, like any treatment, some mild side effects might occur. The studies also found that Imdusiran effectively reduced the hepatitis B virus, offering promise for those with chronic hepatitis B.12345
Why do researchers think this study treatment might be promising for hepatitis B?
Unlike the standard treatments for chronic Hepatitis B, which often include antiviral medications like entecavir and tenofovir, Imdusiran (AB-729) offers a new approach. This treatment works by targeting the virus's RNA, potentially reducing the virus's ability to replicate and cause liver damage. Researchers are excited about Imdusiran because it is administered via subcutaneous injections every eight weeks, which could offer a more convenient dosing schedule compared to daily oral medications. Additionally, its unique mechanism of action might provide a new avenue to reduce viral load and improve patient outcomes.
What evidence suggests that Imdusiran might be an effective treatment for chronic hepatitis B?
Research shows that Imdusiran (AB-729), the treatment under study in this trial, holds promise for treating chronic hepatitis B. Studies have found that up to 50% of patients using Imdusiran achieved a functional cure, meaning the virus became inactive in their bodies. Imdusiran targets and reduces a protein produced by the virus, helping to control the virus and boost the immune system. This treatment effectively lowers the virus's activity and the substances that trigger an immune response. Current evidence suggests that Imdusiran could be a strong option in the fight against chronic hepatitis B.12367
Are You a Good Fit for This Trial?
This trial is for adults over 18 with chronic hepatitis B who've been on HBV oral antiviral treatments for at least 6 months and have a certain level of hepatitis B surface antigen. They must be in good health, not pregnant, willing to continue their current treatment, and use contraception if applicable.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive subcutaneous injections of Imdusiran (AB-729), one injection every 8 weeks for a total of 4 doses, with liver biopsies conducted at the first dose and 8 weeks after the last dose
Follow-up
Participants are monitored for safety and effectiveness after treatment, with an optional third liver biopsy at the end of the study
What Are the Treatments Tested in This Trial?
Interventions
- Imdusiran (AB-729)
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Maryland, Baltimore
Lead Sponsor
Arbutus Biopharma Corporation
Industry Sponsor