Status:
ACTIVE_NOT_RECRUITING
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 C5...
Detailed 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...
Eligibility Criteria
Inclusion
- Key
- All participants who completed their participation in an Alexion sponsored clinical study with danicopan as an add on to a C5i treatment.
- Patient is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- Documentation of vaccination for Neisseria meningitidis: All participants must be revaccinated as per national vaccination guidelines or local practice for vaccination use with complement inhibitors.
- Key
Exclusion
- Any medical condition (for example, cardiac, pulmonary, renal, oncologic, or psychiatric) that, in the opinion of the Investigator, might interfere with participation in the study, pose any added risk to the participant, or confound the assessment of the participant.
- Patient has been permanently discontinued from danicopan in the parent study for any reason other than enrollment into this LTE study.
- Female participants who are pregnant, breastfeeding, or intending to conceive during the course of the study.
Key Trial Info
Start Date :
October 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05389449
Start Date
October 28 2022
End Date
July 31 2026
Last Update
December 31 2025
Active Locations (45)
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1
Research Site
Los Angeles, California, United States, 90089
2
Research Site
Chicago, Illinois, United States, 60612
3
Research Site
Baltimore, Maryland, United States, 21231
4
Research Site
Kansas City, Missouri, United States, 64111