A Registry Study of Treatment With Bulevirtide in Participants With Chronic Hepatitis D Infection
This study is gathering information on people living with a long-lasting liver condition called chronic hepatitis D infection who are being treated with a medicine called HEPCLUDEX. Researchers want to see if this treatment helps prevent serious liver problems like the liver not working properly, liver cancer, or needing a liver transplant, over a period of about three years (144 weeks). They will also be tracking how many people develop scarring of the liver (cirrhosis) and any side effects or serious issues that might occur. This is a real-world study, meaning it's looking at how the treatment works in regular use, rather than in a highly controlled environment.
At a glance
What is this study about?
This study is about a medicine called HEPCLUDEX for people who have a long-term liver infection called chronic hepatitis D. Hepatitis D is a type of virus that can cause serious damage to your liver over time. This particular study is like keeping a careful watch on patients who are already receiving HEPCLUDEX.
The main goal is to understand how well HEPCLUDEX helps prevent serious liver problems in people using it over a period of about three years. These serious problems can include things like the liver struggling to work properly (which might show up as swelling, yellow skin, or confusion), liver cancer, needing a new liver through a transplant, or liver-related death. By collecting this information, doctors can better understand how the medicine is helping people in their daily lives.
The study will also look at other important things. For example, for people who don't have severe liver scarring (cirrhosis) at the start, the study will check how many might develop it during treatment. It will also track any unwanted effects of the medicine, from mild discomforts to more serious issues, and see if people stop taking the medicine because of these effects. This helps build a full picture of the medicine's safety and how well people tolerate it.
Key takeaways
- This study is observing how HEPCLUDEX works for chronic hepatitis D over three years.
- It aims to understand if the treatment prevents serious long-term liver complications.
- It also tracks if patients develop liver scarring or experience side effects.
- This is a 'real-world' study, collecting data from routine patient care.
- Participation will not involve extra appointments or tests beyond your usual medical care.
Who may be eligible?
This study is open to adults aged 18 and over, with no upper age limit. Both men and women can take part.
The main requirement is that you have a long-lasting hepatitis D infection and your doctor has decided that treatment with HEPCLUDEX is suitable for you. This study is generally for people who are already being treated with HEPCLUDEX, rather than people starting it for the first time as part of a trial.
Your doctor will be able to tell you if you meet all the specific criteria for joining this study.
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.
- Am I 18 years old or older?
- Do I have a long-term (chronic) hepatitis D infection?
- Is my doctor treating me with HEPCLUDEX?
- Am I willing for information from my regular appointments to be used for research?
What does participation involve?
If you participate in this study, it basically means your doctors will be carefully recording information about your health and your treatment with HEPCLUDEX over a period of about 144 weeks, which is roughly three years. This isn't a study where you are given a new or experimental drug; it's about watching how HEPCLUDEX, a medicine your doctor has already decided is right for you, works in the real world.
There won't be extra visits or assessments specifically for the study beyond what your doctor would normally recommend for your hepatitis D treatment. Your regular check-ups, blood tests, and scans will provide the information needed for the study. The study team will simply be collecting and analysing this information to better understand the long-term effects of HEPCLUDEX.
Potential risks and benefits
Locations (7)
- —UnverifiedFrance
- —UnverifiedAustria
- —UnverifiedGermany
- —UnverifiedRomania
- —UnverifiedBelgium
- —UnverifiedSpain
- —UnverifiedNetherlands
Common questions
What is chronic hepatitis D?
Chronic hepatitis D is a long-term liver infection caused by the hepatitis D virus. It can lead to serious liver damage if not treated.
What is HEPCLUDEX?
HEPCLUDEX is a medicine used to treat chronic hepatitis D infection. Your doctor can give you more details about how it works.
Will I get extra tests or appointments if I join?
No, this study typically uses information from your standard medical care, so you won't usually have extra visits or tests just for the study.
Why is this study important?
This study helps doctors learn more about how HEPCLUDEX affects patients with chronic hepatitis D over a long time, especially in preventing serious liver problems.
Can I leave the study at any time?
Yes, you are completely free to leave the study at any point without it affecting your ongoing 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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