Tobevibart + Elebsiran for Hepatitis
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of two treatments, tobevibart and elebsiran, to determine their effectiveness in treating chronic hepatitis delta, a liver infection. Researchers aim to assess how well these drugs work together and their safety for long-term use. Participants will either begin treatment immediately or after a delay, allowing for a comparison of immediate and delayed effects. Individuals with chronic hepatitis delta for at least six months who are already on a specific type of hepatitis B medication may be suitable for this study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Do I need to stop my current medications to join the trial?
The trial does not specify if you need to stop taking your current medications. However, you must be on NRTI therapy for HBV or have low HBV DNA levels to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of tobevibart and elebsiran is generally well-tolerated. In an earlier study, 66% of people with chronic hepatitis delta experienced positive results with this treatment. Importantly, no major safety issues emerged after 12 weeks of treatment, suggesting the treatment is safe for most people. While every treatment can have side effects, the available data on tobevibart and elebsiran indicates a good safety record.123
Why do researchers think this study treatment might be promising?
Researchers are excited about Tobevibart + Elebsiran for treating hepatitis because they offer a novel approach compared to current standard treatments like antiviral medications and interferons. Most treatments for hepatitis work by directly inhibiting viral replication, but Tobevibart + Elebsiran target different pathways. Tobevibart is designed to modulate the immune response, potentially offering better control over the virus, while Elebsiran works to enhance this effect further. This combination could provide a more comprehensive and long-lasting solution for patients, potentially improving outcomes and reducing the chance of relapse.
What evidence suggests that this trial's treatments could be effective for chronic hepatitis delta?
Studies have shown that the combination of tobevibart and elebsiran holds promise for treating chronic hepatitis delta. In one study, 66% of participants had no detectable hepatitis delta virus in their blood after receiving the treatment, indicating the virus was no longer present. Tobevibart effectively targets various viruses, while elebsiran significantly reduces virus production. Together, these drugs appear to suppress the virus effectively, offering hope for those with this condition. Participants in this trial will receive the combination of tobevibart and elebsiran, as both treatment arms include this combination.12456
Are You a Good Fit for This Trial?
This trial is for individuals with chronic hepatitis delta virus (HDV) infection. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and may be required to have a confirmed diagnosis of HDV.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Observational
Participants are observed before starting treatment
Treatment
Participants receive tobevibart + elebsiran for 240 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Elebsiran
- Tobevibart
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vir Biotechnology, Inc.
Lead Sponsor