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A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official title:
A Long-term Extension (LTE) Study to Characterize the Safety and Efficacy of Danicopan as an Add-on Therapy to a Complement Component 5 Inhibitor (C5i) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Previously Treated With Danicopan in an Alexion-sponsored Clinical Study

Clinical Trial Summary

This is a single-arm long-term extension study that will enroll participants with PNH who have completed participation in Alexion-sponsored clinical studies with danicopan as an add on therapy to a C5i.

Clinical Trial Description

The total duration of the study will be up to 3 years. Eligible participants must complete all study assessments on the parent protocol before starting this study. All participants entering this study will receive danicopan as an add-on to a background C5i therapy. The only allowed C5i therapies are eculizumab and ravulizumab. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05389449
Study type Interventional
Source Alexion Pharmaceuticals, Inc.
Contact
Status Active, not recruiting
Phase Phase 3
Start date October 28, 2022
Completion date January 31, 2027
View Details
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