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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
Sponsor: Alexion Pharmaceuticals, Inc.
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2022-10-28
Completion Date
2026-07-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Danicopan
Oral tablet
Locations (45)
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Los Angeles, California, United States
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Chicago, Illinois, United States
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Baltimore, Maryland, United States
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Kansas City, Missouri, United States
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Long Island City, New York, United States
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Cleveland, Ohio, United States
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Dallas, Texas, United States
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Porto Alegre, Brazil
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Rio de Janeiro, Brazil
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Toronto, Ontario, Canada
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Brno, Czechia
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Lille, France
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Paris, France
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Pessac, France
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Pierre-Bénite, France
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Athens, Greece
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Thessaloniki, Greece
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Haifa, Israel
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Jerusalem, Israel
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Avellino, Italy
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Bassano del Grappa, Italy
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Florence, Italy
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Milan, Italy
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Reggio Calabria, Italy
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Roma, Italy
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Bunkyō City, Japan
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Kyoto, Japan
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Osaka, Japan
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Shibuya-ku, Japan
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Tsukuba, Japan
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Kota Kinabalu, Malaysia
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Kuching, Malaysia
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Miri, Malaysia
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Gdansk, Poland
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Seoul, South Korea
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Seoul, South Korea
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Suwon, South Korea
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Badalona, Spain
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Barcelona, Spain
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Majadahonda, Spain
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Seville, Spain
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Bangkok, Thailand
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Airdrie, United Kingdom
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Leeds, United Kingdom
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London, United Kingdom