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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 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.

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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.

Conditions Studied

Paroxysmal Nocturnal Hemoglobinuria (PNH)

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

FieldValue
Enrollment Target 202 participants
Start Date 2017-05-17
Est. Completion 2022-02-21
Phase Phase 3

Sponsor

Alexion Pharmaceuticals

162 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03056040

The ClinicalTrials.gov registry entry for NCT03056040 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 85-participant average among 5 other Paroxysmal Nocturnal Hemoglobinuria (PNH) trials with a reported enrollment target (138% higher). The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 7 distinct geographic areas - top geographies include 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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