Early Phase 1 Wilson Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older (any gender)
• You have been diagnosed with Wilson's Disease according to specific medical guidelines, with a diagnosis confirmed at least one year before joining the study, and a particular protein in your blood (ceruloplasmin) is at a very low level
• Your Wilson's Disease has been confirmed by genetic testing showing changes in both copies of a specific gene called ATP7B
• You have been following a low-copper diet for at least six months before the study and are willing to continue doing so throughout the trial
• If you are able to have children, you agree to use reliable contraception from the start of the study until six months after your last dose
• You have been stable on your current Wilson's Disease treatment (such as D-penicillamine, trientine, zinc preparations, or similar medicines) for at least six months with no changes to your drugs or doses, and you are allowed to continue these treatments during the trial
• Your condition is considered well-controlled, meaning certain specific measurements of copper in your blood and urine, and a liver enzyme level, all fall within acceptable ranges (confirm with trial site for exact values)
• You are willing and able to follow the study instructions and complete all required steps
• You are joining voluntarily and have signed a consent form

Who may not be able to join:

• You have had an allergic reaction or cannot tolerate the study drug
• Your Wilson's Disease has caused serious neurological or psychiatric complications
• You have previously had a liver transplant
• You have another liver condition, such as hepatitis, alcoholic liver disease, cirrhosis, liver failure, or liver cancer, or your liver disease severity score is above a certain level (confirm with trial site)
• You have another condition that causes your red blood cells to break down or causes anaemia, such as sickle cell disease or a serious infection
• You have another condition affecting your nervous system, such as Parkinson's disease, epilepsy, certain movement disorders, or a history of schizophrenia or suicide attempts
• Certain blood test results at the time of screening are outside acceptable ranges, including low red blood cell levels, poor kidney function, abnormal liver markers, low platelet count, or low white blood cell count (confirm with trial site for exact values)
• You have had a gastrointestinal bleed (bleeding in the stomach or gut) in the six months before joining
• You have had moderate to severe depression, suicidal thoughts, or serious mental health episodes in the six months before joining
• You have an uncontrolled condition affecting your heart, kidneys, hormones, digestion, blood, or a current cancer diagnosis
• You have an active hepatitis B or C infection, or are HIV positive
• You are currently pregnant or breastfeeding
• You have taken part in another clinical trial in the past three months, or plan to join one during this study
• The trial team decides for any other reason that the study may not be appropriate for you (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.