A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
Researchers are running a new study to see if a combination of two medicines, tobevibart and elebsiran, can help people with a long-term liver infection called hepatitis D. This is a "Phase 3" study, which means it's one of the final stages of testing before a medicine might be made widely available. The study will openly compare the new treatment with people starting treatment at a later date. They want to find out if these medicines are effective and safe for treating chronic hepatitis D. It's being carried out in many different medical centres.
At a glance
What is this study about?
This research is looking into a new way to treat chronic hepatitis D, a long-lasting liver infection. Hepatitis D often occurs in people who also have hepatitis B. The study is particularly interested in combining two new drugs, called tobevibart and elebsiran, to see if they can work better together.
This is a really important step (called a "Phase 3" study) to understand if these new treatments are helpful and safe for people with chronic hepatitis D. Scientists need to gather a lot of information to make sure new medicines are the best they can be.
The study will involve different groups of people. Some will receive the new combination treatment, while others will start their treatment at a later time. This comparison helps researchers clearly see the effects of the new drugs. The goal is to find effective new ways to manage this complex liver condition.
Key takeaways
- Tests new combination treatment for chronic hepatitis D.
- Compares new treatment to delayed treatment.
- Focuses on safety and effectiveness.
- Open to adults aged 18-70 with specific liver health criteria.
- Requires regular clinic visits and health checks.
Who may be eligible?
To join this study, you need to be an adult between 18 and 70 years old. You must have chronic (long-term) hepatitis D infection, which means you've had it for at least 6 months. If you're already taking medicine for hepatitis B, you need to have been on it for at least 12 weeks, or your hepatitis B virus levels must be very low.
Your liver health is also considered. Your liver enzyme levels (called ALT) should be slightly raised but not too high. You can join if you have no scarring of the liver (non-cirrhotic) or if you have some scarring but your liver is still working well (compensated cirrhosis).
There are also some reasons why you might not be able to join. For example, if you have other serious health problems, certain liver diseases not related to hepatitis B or D, or if you've had severe allergic reactions to medicines in the past. People with a history of certain immune problems or recent alcohol/drug abuse would also not be able to take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 70 years old?
- Have you had chronic hepatitis D for at least 6 months?
- Is your hepatitis B infection controlled (if you have it)?
- Are your liver enzyme levels (ALT) slightly raised, but not too high?
- Do you have no severe scarring of the liver, or scarring but your liver is working well?
What does participation involve?
If you decide to take part in this study, you'll be assigned to either receive the new combination treatment (tobevibart and elebsiran) or to start treatment later. Because it's an "open-label" study, both you and the study team will know which group you are in. You will have regular visits to the clinic where doctors and nurses will check your health, take blood tests, and assess how the treatment is affecting you. You'll also receive the study medication during these visits or be given it to take home. The study will carefully monitor your progress and any side effects. The total duration of your participation, including follow-up appointments after treatment, will be explained in detail by the study team.
Potential risks and benefits
Locations (39)
- Investigative SiteVerified postcodeChandler, United States
- Investigative SiteVerified postcodeLos Angeles, United States
- Investigative SiteVerified postcodeRedwood City, United States
- Investigative SiteVerified postcodeSan Francisco, United States
- Investigative SiteVerified postcodeDeLand, United States
- Investigative SiteVerified postcodeChicago, United States
- Investigative SiteVerified postcodeBaltimore, United States
- Investigative SiteVerified postcodeHillsborough, United States
- Investigative SiteVerified postcodeNew York, United States
- Investigative SiteVerified postcodeNew York, United States
- Investigative SiteVerified postcodeNew York, United States
- Investigative SiteVerified postcodeMurray, United States
Common questions
What is chronic hepatitis D?
It's a long-lasting liver infection caused by the hepatitis delta virus, which only affects people who also have hepatitis B.
What are tobevibart and elebsiran?
These are two new medicines being tested together to see if they can help treat chronic hepatitis D.
What does 'Phase 3' mean for this study?
This means it's a large and important step in testing these medicines. It looks at how well they work and if they are safe, often comparing them to existing treatments or a delayed start to treatment.
Will I know if I'm getting the new treatment?
Yes, this is an 'open-label' study, meaning you and the study team will know if you are receiving the active treatment or are in the delayed treatment group.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and this will not affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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