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

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06449001
Study type Interventional
Source Alexion Pharmaceuticals, Inc.
Contact Alexion Pharmaceuticals, Inc. (Sponsor)
Phone 1-855-752-2356
Email clinicaltrials@alexion.com
Status Not yet recruiting
Phase Phase 3
Start date August 23, 2024
Completion date January 28, 2028
View Details
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