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NCT03056040 · ClinicalTrials.gov registry record · Phase 3
ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab
A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 202
- Enrollment target
- 20
- Study locations
NCT03056040: Completed Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH), sponsored by Alexion Pharmaceuticals.
NCT03056040 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH) that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 202 participants, above the 85-participant average among 5 other Paroxysmal Nocturnal Hemoglobinuria (PNH) trials with a reported enrollment target (138% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03056040, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria (PNH), has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 202 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 were clinically stable after having been treated with eculizumab for at least 6 months.
Primary Outcome
Lactate dehydrogenase (LDH) is an indicator of intravascular hemolysis that occurs in participants with paroxysmal nocturnal hemoglobinuria. A decrease in LDH indicates reduction (improvement) in hemolysis. Baseline was defined as the average of all available on-study assessments prior to the first study drug infusion. The percent change in LDH was analyzed using a mixed-effect model for repeated measures (MMRM) with the fixed, categorical effects of treatment, study visit, and study visit by tr
Conditions Studied
Interventions
- BIOLOGICAL Ravulizumab
- BIOLOGICAL Eculizumab
Study Locations (20)
Other
- Research Site - Canberra
- Research Site - Kogarah
- Research Site - Liverpool
- Research Site - Melbourne
- Research Site - Woolloongabba
- Research Site - Amiens
- Research Site - La Tronche
- Research Site - Marseille
- Research Site - Nice
- Research Site - Paris
- Research Site - Pierre-Bénite
- Research Site - Saint-Priest-en-Jarez
California
- Research Site - Duarte
- Research Site - Los Angeles
Ontario
- Research Site - Toronto
- Research Site - Toronto
Maryland
- Research Site - Baltimore
Michigan
- Research Site - Detroit
New York
- Research Site - The Bronx
Quebec
- Research Site - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 202 participants |
| Start Date | 2017-05-17 |
| Est. Completion | 2022-02-21 |
| Phase | Phase 3 |
What the finished NCT03056040 record still lists
NCT03056040 is an interventional study that assigns participants to a tested intervention. The registered 202 participants enrollment target is mid-sized for trials with a published cap, above the 85-participant average among 5 other Paroxysmal Nocturnal Hemoglobinuria (PNH) trials with a reported enrollment target (138% 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.
NCT03056040 names 20 study sites across 7 states, led by Other, California, Ontario.
Frequently Asked Questions
What is clinical trial NCT03056040 about?
NCT03056040 is a clinical study titled "ALXN1210 Versus Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab". The primary purpose of this study was to assess the noninferiority of ravulizumab compared to eculizumab in adult participants with PNH who were clinically stable after having been treated with eculizumab for at least 6 months.
What is the current status of trial NCT03056040?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2017-05-17. Estimated completion is 2022-02-21.
What conditions does trial NCT03056040 study?
This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH).
What interventions are being tested in trial NCT03056040?
The interventions under investigation include: Ravulizumab (BIOLOGICAL), Eculizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03056040?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03056040 being conducted?
This trial has 20 study locations across California, Maryland, Michigan, New York, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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