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A Multicenter, Randomized, Controlled, Open-label, Rater-blinded Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease
This study is being conducted to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics of ALXN1840 versus standard of care in pediatric participants with Wilson disease (WD).
Participants who complete the 48 weeks of treatment in Period 1 will have the option to receive ALXN1840 for 24 weeks in Period 2 (open-label extension). Safety will be monitored throughout the study.
Age
3 - 17 years
Sex
ALL
Healthy Volunteers
No
Research Site
Parkville, Australia
Research Site
South Brisbane, Australia
Research Site
Lille, France
Research Site
Toulouse, France
Research Site
Hanover, Germany
Research Site
Tübingen, Germany
Research Site
Kumamoto, Japan
Research Site
Kurume-shi, Japan
Research Site
Meguro-ku, Japan
Research Site
Sapporo, Japan
Start Date
September 13, 2021
Primary Completion Date
June 26, 2023
Completion Date
June 26, 2023
Last Updated
October 23, 2024
40
ACTUAL participants
ALXN1840
DRUG
Standard of Care
DRUG
Lead Sponsor
Alexion Pharmaceuticals, Inc.
NCT06573723
NCT07046507
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06762509