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Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria
Sponsor: Novartis Pharmaceuticals
Summary
This study is an open-label, single arm, multicenter, roll-over extension study to characterize long-term safety, tolerability and efficacy of iptacopan and to provide access to iptacopan to patients with PNH who have completed Novartis-sponsored Phase 2 or 3 studies with iptacopan
Official title: An Open Label, Multicenter Roll-over Extension Program (REP) to Characterize the Long-term Safety and Tolerability of Iptacopan (LNP023) in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Completed PNH Phase 2 and Phase3 Studies With Iptacopan
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
208
Start Date
2021-07-27
Completion Date
2027-10-19
Last Updated
2025-03-19
Healthy Volunteers
No
Conditions
Interventions
Iptacopan
Taken orally b.i.d. Dosage supplied: 200 mg Dosage form: hard gelatin capsule Route of administration: oral
Locations (57)
City Of Hope
Duarte, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
Univ of California Irvine (Chao Family Comprehensive Cancer Center)
Orange, California, United States
Lakes Research
Miami Lakes, Florida, United States
Augusta University
Augusta, Georgia, United States
Montefiore Medical Center
The Bronx, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Prisma Health Upstate
Greenville, South Carolina, United States
Novartis Investigative Site
Santo André, São Paulo, Brazil
Novartis Investigative Site
São Paulo, São Paulo, Brazil
Novartis Investigative Site
Beijing, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Tianjin, China
Novartis Investigative Site
Ostrava, Poruba, Czechia
Novartis Investigative Site
Brno-Bohunice, Czechia
Novartis Investigative Site
Lille, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Nice, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Toulouse, France
Novartis Investigative Site
Aachen, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Essen, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Riesa, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Ascoli Piceno, AP, Italy
Novartis Investigative Site
Avellino, AV, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Milan, MI, Italy
Novartis Investigative Site
Roma, RM, Italy
Novartis Investigative Site
Torino, TO, Italy
Novartis Investigative Site
Bassano del Grappa, Vicenza, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Fukushima, Fukushima, Japan
Novartis Investigative Site
Kanazawa, Ishikawa-ken, Japan
Novartis Investigative Site
Isehara, Kanagawa, Japan
Novartis Investigative Site
Suwa, Nagano, Japan
Novartis Investigative Site
Suita, Osaka, Japan
Novartis Investigative Site
Shinjuku Ku, Tokyo, Japan
Novartis Investigative Site
Kyoto, Japan
Novartis Investigative Site
Niigata, Japan
Novartis Investigative Site
Vilnius, Lithuania
Novartis Investigative Site
Kota Kinabalu, Sabah, Malaysia
Novartis Investigative Site
Kuching, Sarawak, Malaysia
Novartis Investigative Site
Nijmegen, Netherlands
Novartis Investigative Site
Singapore, Singapore
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Seoul, South Korea
Novartis Investigative Site
Donostia / San Sebastian, Basque Country, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Santiago de Compostela, Galicia, Spain
Novartis Investigative Site
Hualien City, Taiwan
Novartis Investigative Site
Taipei, Taiwan
Novartis Investigative Site
Istanbul, Turkey (Türkiye)
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom
Novartis Investigative Site
London, United Kingdom