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NCT03406507 · ClinicalTrials.gov registry record · Phase 3

A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria

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

Completed
Registry status
Phase 3
Development phase
13
Enrollment target
9
Study locations

NCT03406507: Completed Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, sponsored by Alexion Pharmaceuticals.

NCT03406507 is a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 13 participants, below the 264-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (95% lower). The trial reports 9 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03406507, a Phase 3 study of Paroxysmal Nocturnal Hemoglobinuria, has completed, sponsored by Alexion Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
13 participants
Enrollment target
9
Study locations

Study Summary

The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).

Primary Outcome

Blood samples for determination of ravulizumab Cmax were collected before and after administration of study drug at designated time points. Results are reported in micrograms/milliliter (μg/mL).

Interventions

  • BIOLOGICAL Ravulizumab

Study Locations (9)

Other

  • Clinical Trial Site - Paris
  • Clinical Trial Site - Utrecht
  • Clinical Trial Site - Oslo
  • Clinical Trial Site - Moscow
  • Clinical Trial Site - Saint Petersburg
  • Clinical Trial Site - Leeds
  • Clinical Trial Site - London

Georgia

  • Clinical Trial Site - Atlanta

Wisconsin

  • Clinical Trial Site - Milwaukee

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2018-02-22
Est. Completion 2022-08-25
Phase Phase 3
Alexion Pharmaceuticals

162 total trials

What the finished NCT03406507 record still lists

NCT03406507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 264-participant average among 14 other Paroxysmal Nocturnal Hemoglobinuria trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Paroxysmal Nocturnal Hemoglobinuria appearing as the primary indexed condition, and to 1 intervention - of which Ravulizumab is the first listed.

NCT03406507 lists 9 locations in 3 states (Other, Georgia, Wisconsin).

Frequently Asked Questions

What is clinical trial NCT03406507 about?

NCT03406507 is a clinical study titled "A Study of Ravulizumab (ALXN1210) in Children and Adolescents With Paroxysmal Nocturnal Hemoglobinuria". The purpose of this study was to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, and efficacy of ravulizumab in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH).

What is the current status of trial NCT03406507?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 13 participants. The study started on 2018-02-22. Estimated completion is 2022-08-25.

What conditions does trial NCT03406507 study?

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

What interventions are being tested in trial NCT03406507?

The interventions under investigation include: Ravulizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT03406507?

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

Where is trial NCT03406507 being conducted?

This trial has 9 study locations across Georgia, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT03406507's enrollment target sits among peer trials

13 14th of 14 higher than 1 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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Source: ClinicalTrials.gov NCT03406507, the US trial registry maintained by the National Library of Medicine. NCT03406507 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.