Early Access Program for ALXN1840 in Patients With Wilson Disease
Wilson Disease
About this trial
This is an expanded access trial for Wilson Disease focused on measuring Wilson Disease, ALXN1840
Eligibility Criteria
Inclusion Criteria: ≥ 3 years of age or older at the time of providing informed consent/assent and expressed desire to continue treatment with ALXN1840. Confirmed diagnosis of WD. Has completed one of the following ALXN1840 clinical studies: ALXN1840-WD-205 WTX101-301 ALXN1840-WD-302 Other ALXN1840 studies In the Treating Physician's medical opinion, the potential benefits of treatment with ALXN1840 outweigh the potential risks for the participant. Participant or legal representative provided informed consent/assent to be treated with ALXN1840 through this EAP. Female participants of childbearing potential and male participants must follow protocol-specified-contraception guidance. Exclusion Criteria: Eligible for and able to participate in an Alexion-sponsored study of ALXN1840. Unwilling or unable to comply with the Treating Physician's treatment plan related to this EAP for any reason. Has decompensated hepatic cirrhosis. Model for End-Stage Liver Disease (MELD) score > 13. Modified Nazer Score > 7. End-stage renal disease on dialysis (chronic kidney disease stage 5 [CKD 5]) or creatinine clearance < 30 mL/min. Known hypersensitivity to ALXN1840, ALXN1840 excipients, or any of the ingredients contained in ALXN1840. Women who are nursing or pregnant (or women who are planning to become pregnant during treatment with ALXN1840).