RecruitingPhase 3NCT06449001

Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With PNH Who Have Clinically Significant Extravascular Hemolysis

A Phase 3 Open-Label Study of Danicopan as Add-on Treatment to Ravulizumab or Eculizumab in Pediatric Participants With Paroxysmal Nocturnal Hemoglobinuria Who Have Clinically Significant Extravascular Hemolysis


Sponsor

Alexion Pharmaceuticals, Inc.

Enrollment

6 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to evaluate efficacy of danicopan as add-on treatment to ravulizumab or eculizumab as assessed by hemoglobin (Hgb) change from Baseline at Week 12 in pediatric participants with paroxysmal nocturnal hemoglobinuria (PNH) and clinically significant extravascular hemolysis (CS-EVH).


Eligibility

Min Age: 12 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Danicopan for people with extravascular hemolysis, pnh, and other related conditions. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 12 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDanicopan

Participants will receive danicopan on a weight-based dosing regimen.


Locations(4)

Research Site

Saskatoon, Saskatchewan, Canada

Research Site

Paris, France

Research Site

Leeds, United Kingdom

Research Site

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06449001


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