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Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease

NCT05047523 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-10-23

Study results available
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Summary

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).

Conditions

  • Wilson Disease

Interventions

DRUG

ALXN1840

Administered as an oral tablet.

DRUG

Standard of Care

Depending on the site/region, participants randomized to receive Standard of Care treatment will receive trientine, penicillamine, zinc, or a combination of these medicines, administered according to standard regimens.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Eugene S. Swenson, MD, PhD · Alexion Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-13
Primary Completion
2023-06-26
Completion
2023-06-26
FDA Drug
Yes

Countries

  • Australia
  • France
  • Germany
  • Japan
  • Poland
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05047523 on ClinicalTrials.gov