Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease

Exclusion Criteria

• •Decompensated hepatic cirrhosis
• •MELD score \> 13
• •Modified Nazer score \> 7
• •Clinically significant gastrointestinal bleed within past 3 months
• •Alanine aminotransferase \> 2 X upper limit of normal (ULN) for participants treated for \> 28 days with WD therapy (Cohort 1)
• •Alanine aminotransferase \> 5 X ULN for treatment-naïve participants or participants who have been treated for ≤ 28 days (Cohort 2)
• •Marked neurological disease requiring either nasogastric feeding or intensive inpatient medical care
• •Hemoglobin \< 9 grams/deciliter
• •History of seizure activity within 6 months prior to informed consent
• •Pregnant (or women who are planning to become pregnant) or breastfeeding women
• •Active infection with hepatitis B virus (positive hepatitis B surface antigen) or C virus or seropositivity for human immunodeficiency virus (HIV)
• •Previous treatment with tetrathiomolybdate
• •Participants with end-stage renal disease on dialysis (chronic kidney disease stage 5) or creatinine clearance \< 30 milliliter/minute