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NCT02946463 · ClinicalTrials.gov registry record · Phase 3
ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 272
- Enrollment target
- 20
- Study locations
NCT02946463: Completed Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals.
NCT02946463 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH) that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 272 participants, above the 71-participant average among 5 other Paroxysmal Nocturnal Hemoglobinuria (PNH) trials with a reported enrollment target (283% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02946463, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH), has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 272 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
Primary Outcome
LDH is an indicator of intravascular hemolysis that occurs in participants with paroxysmal nocturnal hemoglobinuria (PNH). A decrease in LDH from above the upper limit of normal (ULN) to below the ULN indicates reduction (improvement) in hemolysis. Normalization of LDH levels (LDH-N) was LDH levels less than or equal to 1 x ULN, from Day 29 through Day 183. The ULN for LDH is 246 U/L.
Conditions Studied
Interventions
- BIOLOGICAL Ravulizumab
- BIOLOGICAL Eculizumab
Study Locations (20)
Other
- Research Site - Buenos Aires
- Research Site - Buenos Aires
- Research Site - Córdoba
- Research Site - Perth
- Research Site - Linz
- Research Site - Vienna
- Research Site - Brussels
- Research Site - Hasselt
- Research Site - Leuven
- Research Site - Rio de Janeiro
- Research Site - Salvador
- Research Site - São Paulo
- Research Site - São Paulo
- Research Site - Pilsen
- Research Site - Prague
California
- Research Site - Los Angeles
- Research Site - Whittier
Texas
- Research Site - Fort Worth
Alberta
- Research Site - Edmonton
Ontario
- Research Site - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 272 participants |
| Start Date | 2016-12-12 |
| Est. Completion | 2023-02-28 |
| Phase | Phase 3 |
What the finished NCT02946463 record still lists
NCT02946463 is an interventional study that assigns participants to a tested intervention. The registered 272 participants enrollment target is mid-sized for trials with a published cap, above the 71-participant average among 5 other Paroxysmal Nocturnal Hemoglobinuria (PNH) trials with a reported enrollment target (283% higher).
The record links to 1 condition, with Paroxysmal Nocturnal Hemoglobinuria (PNH) appearing as the primary indexed condition, and to 2 interventions - of which Ravulizumab is the first listed.
NCT02946463 names 20 study sites across 5 states, led by Other, California, Texas.
Frequently Asked Questions
What is clinical trial NCT02946463 about?
NCT02946463 is a clinical study titled "ALXN1210 (Ravulizumab) Versus Eculizumab in Complement Inhibitor Treatment-Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)". The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who had never been treated with a complement inhibitor (treatment-naïve).
What is the current status of trial NCT02946463?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 272 participants. The study started on 2016-12-12. Estimated completion is 2023-02-28.
What conditions does trial NCT02946463 study?
This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH).
What interventions are being tested in trial NCT02946463?
The interventions under investigation include: Ravulizumab (BIOLOGICAL), Eculizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02946463?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02946463 being conducted?
This trial has 20 study locations across California, Texas, Alberta, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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