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

NCT05389449

Active Not RecruitingPhase 3

Sponsor: Alexion Pharmaceuticals, Inc.

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Interventions: Danicopan

Countries: United States, Brazil, Canada, Czechia, France, Greece, Israel, Italy

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.

Eligibility overview

Sex: ALL

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (45)
  • Los Angeles, California, United States
  • Chicago, Illinois, United States
  • Baltimore, Maryland, United States
  • Kansas City, Missouri, United States
  • Long Island City, New York, United States
  • Cleveland, Ohio, United States
  • Dallas, Texas, United States
  • Porto Alegre, Brazil
  • Rio de Janeiro, Brazil
  • Toronto, Ontario, Canada
  • Brno, Czechia
  • Lille, France
  • Paris, France
  • Pessac, France
  • Pierre-Bénite, France
  • Athens, Greece
  • Thessaloniki, Greece
  • Haifa, Israel
  • Jerusalem, Israel
  • Avellino, Italy
  • Bassano del Grappa, Italy
  • Florence, Italy
  • Milan, Italy
  • Reggio Calabria, Italy
  • Roma, Italy
  • Bunkyō City, Japan
  • Kyoto, Japan
  • Osaka, Japan
  • Shibuya-ku, Japan
  • Tsukuba, Japan
  • + 15 more on CT.gov