Paroxysmal Nocturnal Hemoglobinuria (PNH)
Conditions
Interventions
Drug: Danicopan
Sponsors
Sugita Yuko
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participants Experiencing Treatment-emergent Adverse Events (TEAEs) And Serious TEAEs | — |
Secondary
| Measure | Time frame |
|---|---|
| Change In Hemoglobin Values | — |
Countries
Italy, Japan, United Kingdom, United States
Contacts
Public ContactYuko Sugita
Alexion Pharma GK
Outcome results
None listed