A Study to Assess the Safety, Pharmacokinetics, and Efficacy of ABI-6250 in Participants With Chronic Hepatitis D Virus Infection
This research study is testing a new medicine called ABI-6250 for people who have long-lasting (chronic) hepatitis D virus infection. Hepatitis D is a liver condition that can cause serious health problems. The main goals of this study are to find out if ABI-6250 is safe for patients, how much of the medicine stays in the body and for how long (this is called pharmacokinetics), and if it helps to improve the hepatitis D infection. This is a Phase 2 trial, which means it’s an earlier stage of testing for a new medicine. We are looking for volunteers aged 18 to 70 years old to take part. This study aims to find better ways to treat chronic hepatitis D, as current treatments can be limited.
At a glance
What is this study about?
This study is all about a new medicine, called ABI-6250, for people living with a long-term liver condition called chronic hepatitis D virus (HDV) infection. Hepatitis D is a serious type of liver inflammation caused by a virus. It often occurs in people who also have hepatitis B, and over time, it can lead to severe liver damage.
The main reasons for doing this study are to carefully check if ABI-6250 is safe for people to use, how the body handles the medicine (for example, how quickly it's absorbed and removed), and most importantly, if it can effectively treat the hepatitis D infection. This is an important step because doctors are always looking for better and safer ways to help patients manage and treat chronic hepatitis D.
By understanding more about ABI-6250, researchers hope to develop new and more effective treatments that could improve the health and quality of life for people affected by this challenging condition. This study is considered a 'Phase 2' trial, which means it's an earlier stage of research where we are still learning a lot about the new medicine.
Key takeaways
- This study is testing a new medicine (ABI-6250) for chronic hepatitis D infection.
- It's a Phase 2 trial, focusing on safety and how well the medicine works.
- You must be 18-70 years old and in generally good health, apart from your HDV.
- You cannot have other current serious infections (like HIV or Hepatitis C).
- Participation involves taking the medicine and attending clinic visits for tests.
- You can stop taking part at any time without affecting your normal care.
Who may be eligible?
To join this study, you need to be an adult between 18 and 70 years old. You must have chronic hepatitis D infection, but otherwise, you should be in generally good health. This means a doctor will check your overall health through medical history, a physical exam, and some basic tests.
There are also some reasons why you might not be able to join. For example, if you currently have other serious infections like acute hepatitis A, hepatitis C, or HIV, you wouldn't be able to take part. Also, if you've had a bad allergic reaction to medicines or food in the past, or if you've been treated for hepatitis D in the last six months, this study might not be suitable for you.
It's also important that you haven't taken part in another drug or device study (for conditions other than hepatitis D) too recently. The medical team will carefully review all these points with you to make sure the study is right for your specific health situation.
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?
- Do you have chronic hepatitis D infection?
- Are you generally in good health, apart from your HDV?
- Do you weigh between 18 and 35 on the BMI scale?
- Do you NOT currently have acute hepatitis A, hepatitis C, or HIV?
- Have you NOT been treated for hepatitis D in the last 6 months?
What does participation involve?
If you decide to take part in this study, you will be given the new medicine, ABI-6250. This is the main part of the treatment being tested. The study will involve several visits to the clinic over a period of time. During these visits, the study team will carry out various checks and assessments to see how you are doing and how the medicine is affecting your body.
These checks will likely include things like blood tests, physical examinations, and possibly other tests to monitor your liver health and the hepatitis D virus. The team will carefully explain the full schedule of visits, tests, and how long you'll be in the study, including any follow-up appointments after you stop taking the medicine. All your appointments and any necessary tests will be carefully planned and explained to you.
Potential risks and benefits
Locations (22)
- AP-HP - Beaujon HospitalVerified postcodeClichy, France
- Hôpital Henri-MondorVerified postcodeCréteil, France
- CHU Lyon - Hôpital Croix-RousseVerified postcodeLyon, France
- LLC NeolabVerified postcodeTbilisi, Georgia
- Universitätsklinikum Hamburg-EppendorfVerified postcodeHamburg, Germany
- Medizinische Hochschule HannoverVerified postcodeHanover, Germany
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoVerified postcodeMilan, Italy
- Azienda Ospedaliera UniversitariaVerified postcodeNaples, Italy
- Clinical Republican HospitalVerified postcodeChisinau, Moldova
- New Zealand Clinical ResearchVerified postcodeAuckland, New Zealand
- Aga Khan University HospitalVerified postcodeKarachi, Pakistan
- Dr. Ziauddin HospitalVerified postcodeKarachi, Pakistan
Common questions
What is chronic hepatitis D?
It's a long-lasting liver infection caused by the hepatitis D virus. It can lead to serious liver problems, especially in people who also have hepatitis B.
What is ABI-6250?
ABI-6250 is a new medicine being tested to treat chronic hepatitis D infection. It's not yet approved for general use.
What does 'Phase 2 trial' mean?
Phase 2 means it's an earlier stage of testing for a new medicine. Researchers are looking closely at its safety and how well it works in a small group of people.
Will I get paid for taking part?
The study information does not mention payment. You would need to ask the study team about any expenses or compensation.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason. Your decision 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.
Interested in taking part?
Discussion
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