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NCT03459443 · ClinicalTrials.gov registry record · Phase 2
A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT03459443: Clinical Trial Phase 2 study, sponsored by Alexion Pharmaceuticals.
NCT03459443 is a Phase 2 study that was terminated before completion, run by Alexion Pharmaceuticals. The registered enrollment target is 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03459443, a Phase 2 study, was terminated before completion, sponsored by Alexion Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 22 participants
- Enrollment target
Study Summary
The primary purpose of this study was to evaluate the efficacy of 12 months of oral ACH-0144471 (also known as danicopan and ALXN2040) in participants with C3G or IC-MPGN based on histologic scoring and proteinuria.
Primary Outcome
The composite biopsy score was based on a score incorporating changes in the activity index, glomerular C3c staining, and glomerular macrophage infiltration at the end of the initial 12 months of treatment. The composite renal biopsy index scoring system ranged from 0 to 21, with higher scores indicating worse outcomes.
Interventions
- DRUG Danicopan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2021-03-29 |
| Phase | Phase 2 |
Why NCT03459443 stopped before completion
NCT03459443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 1 intervention - of which Danicopan is the first listed.
NCT03459443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03459443 about?
NCT03459443 is a clinical study titled "A Proof of Concept Study for a 12 Month Treatment in Patients With C3G or IC-MPGN Treated With ACH-0144471". The primary purpose of this study was to evaluate the efficacy of 12 months of oral ACH-0144471 (also known as danicopan and ALXN2040) in participants with C3G or IC-MPGN based on histologic scoring and proteinuria.
What is the current status of trial NCT03459443?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2018-06-20. Estimated completion is 2021-03-29.
What interventions are being tested in trial NCT03459443?
The interventions under investigation include: Danicopan (DRUG).
Who is sponsoring clinical trial NCT03459443?
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 NCT03459443's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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