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Clinical trial of ALXN1840 compared to treatment as usual in participants with Wilson's disease.
THIS STUDY IS BEING CONDUCTED TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS (PK) AND PHARMACODYNAMICS (PD) OF ALXN1840 COMPARED TO TREATMENT AS USUAL (TAU) IN PEDIATRIC PARTICIPANTS WITH WILSON'S DISEASE (WD) AGED 3 TO <18 YEARS AT INCLUSION. PARTICIPANTS MAY NOT HAVE RECEIVED ANY PRIOR TREATMENT OR HAVE BEEN UNDERGOING ANY APPROVED USUAL TREATMENT FOR WD (PENICILLAMINE, TRIENTINE, ZINC).
Technical Summary
- MULTICENTER, RANDOMIZED, CONTROLLED, OPEN-LABEL, EVALUATOR-BLINDED, MULTICENTER STUDY TO ASSESS THE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ALXN1840 COMPARED TO TREATMENT AS USUAL IN PEDIATRIC PARTICIPANTS WITH WILSON'S DISEASE
- Code EudraCT: 2021-001015-82
- Protocol number: ALXN1840-WD-302
- Promoter: Alexion Pharmaceuticals, Inc.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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