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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 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.

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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).

Conditions Studied

Paroxysmal Nocturnal Hemoglobinuria (PNH)

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

FieldValue
Enrollment Target 272 participants
Start Date 2016-12-12
Est. Completion 2023-02-28
Phase Phase 3

Sponsor

Alexion Pharmaceuticals

162 total trials

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What the Registry Record Tells You About NCT02946463

The ClinicalTrials.gov registry entry for NCT02946463 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 272 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 71-participant average among 5 other Paroxysmal Nocturnal Hemoglobinuria (PNH) trials with a reported enrollment target (283% 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.

NCT02946463 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.