A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5… (NCT05389449) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH
United States80 participantsStarted 2022-10-28
Plain-language 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.
Who can participate
SexALL
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Key Inclusion Criteria:
* 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 Criteria:
* 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.
What they're measuring
1
Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs