CSL_Ferroclear_HH_Kappus - Clinical Trial
What is the Purpose of this Study?
In this study, people will take capsules that contain either the study drug, called vamifeport, or a placebo, which looks the same but has no medicine. The study lasts about fourteen months and has around fifteen in person visits. At these visits, people will have blood tests, heart tests called ECGs, MRI scans, and questionnaires.
If someone gets vamifeport, they will take it twice a day in one of two dose groups. One group takes 90 milligrams twice a day, which is one capsule in the morning and one in the evening. The other group takes 270 milligrams twice a day, which is three capsules in the morning and three in the evening. If someone gets a placebo, they will also take either one capsule twice a day or three capsules twice a day, depending on their group.
Hereditary hemochromatosis
Who Can Participate in the Study?
People can join this study if they are 18 years or older and have hereditary hemochromatosis confirmed in their medical history. They must have too much iron in their body, shown by high TSAT levels on two tests, high ferritin levels within a certain range on two tests, and an MRI that shows their liver has too much iron. They must have a body mass index between 18.5 and 32. They also must understand the study and be able to follow all the study requirements.
What is Involved?
This study is being done to find out if a pill called vamifeport is safe and helps people who have hereditary hemochromatosis. This condition causes the body to absorb too much iron. The study will compare vamifeport to a placebo, which looks like the medicine but has no drug in it, to see which works better.
Study Details
