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ACTIVE NOT RECRUITING
NCT04747613
PHASE3

Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Interventions

DRUG

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