Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants with Wilson Disease
Study identifier:WTX101-301
ClinicalTrials.gov identifier:NCT03403205
EudraCT identifier:2017-004135-36
CTIS identifier:N/A
Terminated/Withdrawn
Official Title
A Phase 3, Randomized, Rater-Blinded, Multi-Center Study to Evaluate the Efficacy and Safety of ALXN1840 Administered for 48 Weeks versus Standard of Care in Patients with Wilson Disease Aged 12 Years and Older, with an Extension Period of up to 60 Months
Medical condition
Wilson Disease
Phase
Phase 3
Healthy volunteers
No
Study drug
ALXN1840, SoC Therapy
Sex
All
Actual Enrollment
214
Study type
Interventional
Age
12 Years - n/a
Date
Study Start Date: 22 Feb 2018
Primary Completion Date: 30 Jun 2023
Study Completion Date: 30 Jun 2023
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jun 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: ALXN1840 ALXN1840 was administered orally for 48 weeks at doses ranging from 15 milligrams (mg) every other day (QOD) up to a titrated dose of 60 mg daily. Participants who completed the Primary Evaluation Period had the option to participate in the up to 60-month Extension Period. | Drug: ALXN1840 ALXN1840 administered orally in 15 mg tablets Other Name: Formerly named WTX101 Other Name: Tiomolibdic acid Other Name: Tiomolibdate choline Other Name: Bis-choline tetrathiomolybdate |
| Active Comparator: Standard of Care (SoC) Medication SoC medication was administered for 48 weeks. Participants who completed the Primary Evaluation Period had the option to participate in the up to 60-month Extension Period. | 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. |
Contacts
Investigators
Principal Investigator
Eugene S. Swenson
Alexion Pharmaceuticals, Inc.
