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

NCT03403205 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2024-06-17

Study results available
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Summary

The study will evaluate the efficacy and safety of ALXN1840 (formerly called WTX101) administered for 48 weeks compared to standard of care (SoC) in Wilson Disease (WD) participants aged 12 and older in the Primary Evaluation Period. In addition, efficacy and safety will be evaluated during an optional 60-month Extension Period.

Conditions

  • Wilson Disease

Interventions

DRUG

ALXN1840

ALXN1840 administered orally in 15 mg tablets

DRUG

SoC Therapy

Depending on the site/region, participants randomized to receive SoC 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, M.D., Ph.D. · Alexion Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-22
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Japan
  • New Zealand
  • Poland
  • Russia
  • Serbia
  • Singapore
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

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 NCT03403205 on ClinicalTrials.gov