This research study is looking to enroll approximately 84 adults aged 18 and older who have been diagnosed with hereditary hemochromatosis– a genetic disorder where the body accumulates too much dietary iron.
In this study, researchers will assess what effect an investigational oral drug (now referred to as the study drug) may have on a key indicator of iron overload in adults with hereditary hemochromatosis called Liver Iron Concentration (LIC).
About HFE Related Hereditary Hemochromatosis and the FERROCLEAR study
Hereditary hemochromatosis is a genetic disorder (meaning it is inherited and is part of your genes) where the body accumulates too much dietary iron. Known as “iron overload,” this can lead to serious health issues such as liver disease, heart problems, diabetes and arthritis because excessive iron can damage the organ tissues.
Symptoms can include weight loss, feeling tired, joint or stomach pain, loss of sex drive, and/or memory fog.
Hereditary hemochromatosis is a genetic disorder (meaning it is inherited and is part of your genes) where the body accumulates too much dietary iron. Known as “iron overload,” this can lead to serious health issues such as liver disease, heart problems, diabetes and arthritis because excessive iron can damage the organ tissues.
Symptoms can include weight loss, feeling tired, joint or stomach pain, loss of sex drive, and/or memory fog.
Current treatments include frequent blood draws (phlebotomy), the use of drugs to remove heavy metals from the body (iron chelators), and erythrocytapheresis
(a medical procedure to remove red blood cells before returning the blood back to the body).
In contrast, the study drug is thought to work in two ways: By blocking iron absorption in the intestines AND by acting like a natural substance called hepcidin, which helps distribute iron more effectively to different organs.
Current treatments include frequent blood draws (phlebotomy), the use of
drugs to remove heavy
metals from the body
(iron chelators), and erythrocytapheresis (a medical procedure to remove red blood cells before returning the blood back to the body).
In contrast, the study drug is thought to work in two ways: By blocking iron absorption in the intestines AND by acting like a natural substance called hepcidin, which helps distribute iron more effectively to different organs.
In the FERROCLEAR study, researchers want to
determine if the study drug can reduce liver iron overload when compared to placebo (a ‘dummy’ drug that looks like the study drug but has no therapeutic effect).
They also want to assess how safe and well-tolerated
the study drug is.
If you enroll, you will have a 67% chance of receiving
the study drug versus placebo. Regardless, you will
take a study drug twice/day for about 12 months.
Total participation in the study (including screening
and follow-up) will last about 14 months. You may
withdraw from the study at any time and for any reason.
Act now to see if you may qualify for this study.
In the FERROCLEAR study, researchers want to
determine if the study drug can reduce liver iron overload when compared to placebo (a ‘dummy’ drug that looks like the study drug but has no therapeutic effect). They also want to assess how safe and
well-tolerated the
study drug is.
If you enroll, you will have
a 67% chance of receiving
the study drug versus placebo. Regardless,
you will take a capsule twice/day for about
12 months.
Total participation in the study (including screening
and follow-up) will last about 14 months. You may
withdraw from the study at any time and for any reason.
AcurianHealth helps connect people with research studies. Since 1998, AcurianHealth has referred over 1 million study candidates to 800 research studies all over the world.
*In a research study, the participants may receive investigational study drug or may receive an inactive substance, or placebo, depending on the study design. Participants receive study-related care from a doctor/research team for the duration of the study. For studies that offer compensation, reasonable payments will be made for participation. The length of the study may vary.