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NCT03403205 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease
A Phase 3 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 214
- Enrollment target
NCT03403205: Clinical Trial Phase 3 study, sponsored by Alexion Pharmaceuticals.
NCT03403205 is a Phase 3 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 214 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03403205, a Phase 3 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 214 participants
- Enrollment target
Study 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.
Primary Outcome
dNCC is the directly quantified copper not bound to ceruloplasmin, obtained by inductively coupled plasma mass spectrometry after immunocapture and removal of ceruloplasmin. Baseline was defined as last non-missing value on or before first study drug administration. Least square (LS) mean and standard error (SE) was calculated using analysis of covariance (ANCOVA).
Interventions
- DRUG ALXN1840
- DRUG SoC Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 214 participants |
| Start Date | 2018-02-22 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
Why NCT03403205 stopped before completion
NCT03403205 is an interventional study that assigns participants to a tested intervention. The registered 214 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower).
The record links to 0 conditions, and to 2 interventions - of which ALXN1840 is the first listed.
NCT03403205 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03403205 about?
NCT03403205 is a clinical study titled "Efficacy and Safety of ALXN1840 Administered for 48 Weeks Versus Standard of Care in Participants With Wilson Disease". 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 optio...
What is the current status of trial NCT03403205?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 214 participants. The study started on 2018-02-22. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03403205?
The interventions under investigation include: ALXN1840 (DRUG), SoC Therapy (DRUG).
Who is sponsoring clinical trial NCT03403205?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03403205's enrollment target sits among peer trials
214 1335th of 2000 higher than 666 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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