A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)
This study is called 'FERROCLEAR' and is for adults aged 18 and over who have a specific type of hereditary hemochromatosis. This condition causes the body to absorb too much iron, which can then build up in organs like the liver. The study is testing a new medicine called Vamifeport to see how well it works at lowering these high iron levels in the liver. Researchers will also be checking if the medicine is safe. Some participants will receive Vamifeport, while others will receive a dummy pill (placebo) to fairly compare the new medicine's effects. Everyone involved, including the study doctors, won't know who is getting which.
At a glance
What is this study about?
This study is looking at a new medicine called Vamifeport for adults who have a condition known as hereditary hemochromatosis, specifically the type linked to the HFE gene. If you have this condition, your body absorbs too much iron from your food. Over time, this extra iron can build up in important organs like your liver, heart, and pancreas, which can cause health problems.
The main goal of this study is to see if Vamifeport can help lower the amount of iron stored in the liver. We will measure this using a special type of MRI scan. The study will also carefully check for any side effects to make sure the medicine is safe. Everyone taking part will either receive Vamifeport or a dummy pill (called a placebo) that looks exactly like Vamifeport. Neither you nor your study doctor will know which one you are receiving – this helps us get the most accurate results.
This kind of study, called a Phase 2 trial, is an important step in developing new medicines. It helps us understand if a new treatment is effective and safe enough to move on to larger studies. Your participation could help us learn more about treating this condition in the future.
Key takeaways
- This study is for adults with a specific type of hereditary hemochromatosis (HFE-related).
- It's testing a new medicine called Vamifeport to see if it lowers iron in the liver.
- Participation involves regular clinic visits, blood tests, and MRI scans.
- Some participants will get the study medicine, while others will get a dummy pill (placebo).
- You will be closely monitored for any health changes or side effects.
- Your involvement could help advance treatment for this condition.
Who may be eligible?
To be part of this study, you must be an adult, at least 18 years old. The study is open to both men and women.
The most important thing is that you must have hereditary hemochromatosis linked to the HFE gene. This is a specific type of iron overload condition.
There might be other health requirements or specific things about your condition that the study doctors will need to check to make sure the study medicine is right and safe for you. Your doctor will be able to tell you all the details to see if you can 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 18 years old or older?
- Do you have hereditary hemochromatosis?
- Has your doctor told you that your hemochromatosis is 'HFE-related'?
- Are you comfortable with regular clinic visits and various medical tests, including MRI scans?
What does participation involve?
If you decide to join this study, you will have regular visits to the clinic. During these visits, doctors and nurses will perform various tests and checks, including blood tests and physical examinations. You will also have special MRI scans to measure the iron levels in your liver at different times throughout the study. You will be given either the study medicine, Vamifeport, or a placebo (dummy pill) to take regularly as instructed. The study team will monitor you closely to see how you are responding to the treatment and to check for any side effects. After you finish taking the study medicine, there will be follow-up appointments to ensure your health is stable. The total duration of your participation in the study will be explained in detail by the study team.
Potential risks and benefits
Locations (11)
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- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedCzechia
- —UnverifiedNetherlands
Common questions
What is hereditary hemochromatosis?
It's a condition where your body absorbs and stores too much iron, which can build up in organs and cause problems.
What is a 'placebo'?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active drug. It helps compare the new medicine's effects fairly.
Will I know if I'm getting the real medicine or the placebo?
Neither you, nor your study doctor, will know which treatment you are receiving until after the study is over. This is called 'double-blind'.
What is an MRI scan for my liver?
It's a special scan that uses strong magnets and radio waves to create detailed pictures inside your body, including measuring iron in your liver.
Can I leave the study if I change my mind?
Yes, you have the right to leave the study at any time, for any reason, without it affecting your future 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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