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

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. According to ClinicalTrials.gov, the official US trial registry.

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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
Alexion Pharmaceuticals

162 total trials

What the finished NCT03748823 record still lists

NCT03748823 is an interventional study that assigns participants to a tested intervention. The registered 139 participants enrollment target is mid-sized for trials with a published cap, below the 255-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (45% lower).

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 names 20 study sites across 3 states, led by 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.

Learn More About Clinical Trials

Similar trials for Paroxysmal Nocturnal Hemoglobinuria

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03748823's enrollment target sits among peer trials

139 6th of 14 higher than 9 of 14 other Paroxysmal Nocturnal Hemoglobinuria trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Paroxysmal Nocturnal Hemoglobinuria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03748823, the US trial registry maintained by the National Library of Medicine. NCT03748823 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.