A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants with PNH
Study identifier:ALXN2040-PNH-303
ClinicalTrials.gov identifier:NCT05389449
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
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
Medical condition
paroxysmal nocturnal hemoglobinuria
Phase
Phase 3
Healthy volunteers
No
Study drug
Danicopan
Sex
All
Actual Enrollment
80
Study type
Interventional
Age
n/a - n/a
Date
Study Start Date: 28 Oct 2022
Estimated Primary Completion Date: 31 Jan 2027
Estimated Study Completion Date: 31 Jan 2027
Study design
Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Jul 2024 by Alexion Pharmaceuticals, Inc.
Sponsors
Alexion Pharmaceuticals, Inc.
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Danicopan Participants will receive their last dose of danicopan from the parent study the night prior to Day 1 of this LTE study and will continue daily treatment with danicopan together with their background C5i therapy. | - |
