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NCT04422431 · ClinicalTrials.gov registry record · Phase 2
Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT04422431: Completed Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT04422431 is a Phase 2 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04422431, a Phase 2 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The main objective of the study is to evaluate the change in liver copper (Cu) concentration following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD) who have been previously treated for at least 1 year with standard of care (that is, trientine, penicillamine, or zinc). In the Treatment Period, efficacy and safety of ALXN1840 will be assessed at Week 48.
Primary Outcome
Liver biopsy samples were taken for the assessment of liver Cu concentration. Multiple imputation was used to impute missing data at Week 48 due to any reason based on Baseline values.
Interventions
- DRUG Bis-Choline Tetrathiomolybdate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2020-12-02 |
| Est. Completion | 2023-05-17 |
| Phase | Phase 2 |
What the finished NCT04422431 record still lists
NCT04422431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Bis-Choline Tetrathiomolybdate is the first listed.
NCT04422431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04422431 about?
NCT04422431 is a clinical study titled "Copper Concentration & Histopathologic Changes in Liver Biopsy in Participants With Wilson Disease Treated With ALXN1840". The main objective of the study is to evaluate the change in liver copper (Cu) concentration following 48 weeks of treatment with ALXN1840 in adult participants with Wilson Disease (WD) who have been previously treated for at least 1 year with standard of care (that is, trientine, penicillamine, or ...
What is the current status of trial NCT04422431?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2020-12-02. Estimated completion is 2023-05-17.
What interventions are being tested in trial NCT04422431?
The interventions under investigation include: Bis-Choline Tetrathiomolybdate (DRUG).
Who is sponsoring clinical trial NCT04422431?
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 NCT04422431's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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