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NCT03748823 · ClinicalTrials.gov registry record · Phase 3

Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab

A Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Alexion Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
139
Enrollment target
20
Study locations

NCT03748823 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 139 participants, below the 255-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (45% lower). The trial reports 20 study locations across 3 states.

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The verdict

NCT03748823, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, has completed, sponsored by Alexion Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
139 participants
Enrollment target
20
Study locations

Study Summary

The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 3 months prior to study entry.

Conditions Studied

Paroxysmal Nocturnal Hemoglobinuria

Interventions

  • BIOLOGICAL Ravulizumab
  • COMBINATION_PRODUCT Ravulizumab OBDS

Study Locations (20)

Other

  • Research Site - Liverpool
  • Research Site - Parkville
  • Research Site - Vienna
  • Research Site - Antwerp
  • Research Site - Brussels
  • Research Site - Hasselt
  • Research Site - Leuven
  • Research Site - Botucatu
  • Research Site - Ribeirão Preto
  • Research Site - Rio de de Janeiro
  • Research Site - Salvador
  • Research Site - São Paulo
  • Research Site - São Paulo
  • Research Site - Helsinki
  • Research Site - Amiens
  • Research Site - Brest
  • Research Site - Lille
  • Research Site - Montpellier

California

  • Research Site - Los Angeles

Ontario

  • Research Site - Toronto

Trial Details

FieldValue
Enrollment Target 139 participants
Start Date 2019-02-19
Est. Completion 2023-08-31
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 NCT03748823

The ClinicalTrials.gov registry entry for NCT03748823 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 139 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 255-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (45% lower). 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 appearing as the primary indexed condition, and to 2 interventions - of which Ravulizumab is the first listed.

NCT03748823 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Other, California, Ontario.

Frequently Asked Questions

What is clinical trial NCT03748823 about?

NCT03748823 is a clinical study titled "Ravulizumab Subcutaneous (SC) Versus Ravulizumab Intravenous (IV) in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Eculizumab". The primary objective of this study is to evaluate pharmacokinetics (PK) of ravulizumab administered subcutaneously via an on-body delivery system (OBDS) compared with intravenously administered ravulizumab in adult participants with PNH who are clinically stable on eculizumab for at least 3 months ...

What is the current status of trial NCT03748823?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 139 participants. The study started on 2019-02-19. Estimated completion is 2023-08-31.

What conditions does trial NCT03748823 study?

This clinical trial studies the following conditions: Paroxysmal Nocturnal Hemoglobinuria.

What interventions are being tested in trial NCT03748823?

The interventions under investigation include: Ravulizumab (BIOLOGICAL), Ravulizumab OBDS (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT03748823?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03748823 being conducted?

This trial has 20 study locations across California, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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