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NCT05389449 · ClinicalTrials.gov registry record · Phase 3
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH
A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Alexion Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 80
- Enrollment target
- 20
- Study locations
NCT05389449: Active Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Alexion Pharmaceuticals.
NCT05389449 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that is active but no longer recruiting, run by Alexion Pharmaceuticals. The registered enrollment target is 80 participants, below the 259-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05389449, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, is active but no longer recruiting, sponsored by Alexion Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 80 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.
Conditions Studied
Interventions
- DRUG Danicopan
Study Locations (20)
Other
- Research Site - Porto Alegre
- Research Site - Rio de Janeiro
- Research Site - Brno
- Research Site - Lille
- Research Site - Paris
- Research Site - Pessac
- Research Site - Pierre-Bénite
- Research Site - Athens
- Research Site - Thessaloniki
- Research Site - Haifa
- Research Site - Jerusalem
- Research Site - Avellino
California
- Research Site - Los Angeles
Illinois
- Research Site - Chicago
Maryland
- Research Site - Baltimore
Missouri
- Research Site - Kansas City
New York
- Research Site - Long Island City
Ohio
- Research Site - Cleveland
Texas
- Research Site - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2022-10-28 |
| Est. Completion | 2026-07-31 |
| Phase | Phase 3 |
What the registry record for NCT05389449 still lists
NCT05389449 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 259-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Paroxysmal Nocturnal Hemoglobinuria appearing as the primary indexed condition, and to 1 intervention - of which Danicopan is the first listed.
NCT05389449 names 20 study sites across 9 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05389449 about?
NCT05389449 is a clinical study titled "A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH". This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.
What is the current status of trial NCT05389449?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 80 participants. The study started on 2022-10-28. Estimated completion is 2026-07-31.
What conditions does trial NCT05389449 study?
This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria.
What interventions are being tested in trial NCT05389449?
The interventions under investigation include: Danicopan (DRUG).
Who is sponsoring clinical trial NCT05389449?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05389449 being conducted?
This trial has 20 study locations across California, Illinois, Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Paroxysmal Nocturnal Hemoglobinuria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05389449's enrollment target sits among peer trials
80 8th of 14 higher than 7 of 14 other Paroxysmal Nocturnal Hemoglobinuria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Nocturnal Hemoglobinuria 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
-
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment
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-
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-
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Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
COMPLETED · Phase 3
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