A Seamless, Adaptive, Phase 2b/3, Double-Blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR MD-02) for the Prevention of Esophageal Varices in NASH Cirrhosis.
This research study is looking into a new medicine, Belapectin, for people who have advanced liver scarring (cirrhosis) caused by non-alcoholic fatty liver disease (NAFLD). A common and serious problem with this condition is the development of swollen veins in the gullet (oesophagus) called varices, which can sometimes bleed. This study aims to find out if Belapectin can help prevent these varices from forming in the first place. Participants will receive either Belapectin or a dummy medicine (placebo) without knowing which one they are getting. Researchers will carefully monitor their health over 18 months to see if Belapectin is safe and effective in preventing varices and other liver problems. Both men and women aged 18 and over can take part.
At a glance
What is this study about?
This study is investigating a new medicine called Belapectin. It's designed for people who have a serious liver condition called cirrhosis, which is a type of scarring that happens when the liver is damaged over a long time. In this particular study, they are focusing on cirrhosis caused by something called non-alcoholic fatty liver disease (NAFLD), which is becoming more common.
One of the serious complications of cirrhosis is the development of swollen veins in the tube that carries food from your mouth to your stomach, called the oesophagus. These are known as oesophageal varices, and they can sometimes bleed, which is a medical emergency. The main goal of this study is to see if Belapectin can prevent these varices from forming in people with NAFLD cirrhosis.
Researchers will compare Belapectin to a placebo, which is a dummy medicine that looks just like Belapectin but contains no active drug. This helps them determine if any benefits seen are truly due to the medicine or something else. They will also be looking at other important health factors, like whether Belapectin can reduce the risk of other liver-related problems, such as internal bleeding, fluid build-up in the tummy, or the need for a liver transplant. The study will last for about 18 months, and participants will be carefully monitored throughout.
Key takeaways
- This study evaluates a new drug, Belapectin, for advanced liver scarring (cirrhosis) from NAFLD.
- The main aim is to prevent swollen veins (oesophageal varices) in the gullet.
- Participants will receive either Belapectin or a dummy medicine (placebo).
- The study lasts about 18 months, with regular health checks.
- It's for adults (18+) with NAFLD cirrhosis who meet certain health criteria.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult, 18 years old or older. The study is open to both men and women.
The main condition for taking part is having liver scarring (cirrhosis) that developed because of non-alcoholic fatty liver disease (NAFLD).
There will be other conditions to meet that a doctor involved in the study can explain to you. These might include things like your general health, other medications you're taking, or specific results from your blood tests or liver scans. If you're interested, the research team will check all these details with you to see if the study is a good fit.
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 18 years old or older?
- Do you have liver scarring (cirrhosis)?
- Is your liver scarring due to non-alcoholic fatty liver disease (NAFLD)?
- Are you able to attend regular clinic appointments for about 18 months?
What does participation involve?
If you decide to take part in this study, you'll be given either the new medicine, Belapectin, or a dummy medicine (placebo). Neither you nor your study doctor will know which you are receiving – this is to make sure the results are as fair as possible. The study will last for about 18 months (78 weeks).
During this time, you will have regular visits to the hospital or clinic. These visits will involve health checks, blood tests, and possibly scans or other procedures to monitor your liver health and vital signs. The study team will explain exactly what each visit will involve and how often they will be. You will also receive the study medicine at these visits or be told how to take it at home.
After the main treatment period, there will likely be follow-up appointments to check on your long-term health. The study team will provide you with all the necessary information and support throughout your participation.
Potential risks and benefits
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Common questions
What are oesophageal varices?
These are swollen veins in your gullet (the tube from your mouth to your stomach). They can become a problem if you have severe liver scarring (cirrhosis) and can sometimes bleed.
What is NAFLD cirrhosis?
NAFLD stands for non-alcoholic fatty liver disease. Cirrhosis is severe scarring of the liver. So, NAFLD cirrhosis means your liver scarring is due to fatty liver not caused by alcohol.
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the actual medicine but contains no active drug. It helps researchers see if the real medicine is truly making a difference.
How long will the study last if I join?
The main part of the study, where you receive the medicine, will last for about 18 months (78 weeks). There might be follow-up appointments after that.
Can I stop taking part if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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