Long-term Safety and Tolerability of Iptacopan in Patients With Paroxysmal Nocturnal Hemoglobinuria
Condition(s) studied
Investigational drug(s) / intervention(s)
Iptacopan: Taken orally b.i.d. Dosage supplied: 200 mg Dosage form: hard gelatin capsule Route of administration: oral
Study 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
Eligibility
Primary outcome measure(s)
- Proportion of participants with adverse events — Up to 74 months
Safety evaluations including but not limited to adverse events/serious adverse events, safety laboratory parameters, vital signs, etc. through End of Study visit
Trial sites (60)
| Facility | City | Region | Status |
|---|---|---|---|
| City Of Hope National Med Center | Duarte | California | |
| City Of Hope | Duarte | California | |
| USC Norris Cancer Center | Los Angeles | California | |
| Univ Cali Irvine ALS Neuromuscular | Orange | California | |
| Univ of California Irvine (Chao Family Comprehensive Cancer Center) | Orange | California | |
| Lakes Research | Miami Lakes | Florida | |
| Augusta University Georgia | Augusta | Georgia | |
| Augusta University | Augusta | Georgia | |
| Montefiore Medical Center | The Bronx | New York | |
| Cleveland Clinic Foundation | Cleveland | Ohio | |
| Prisma Health Upstate | Greenville | South Carolina | |
| Novartis Investigative Site | Santo André | São Paulo | |
| Novartis Investigative Site | São Paulo | São Paulo | |
| Novartis Investigative Site | Beijing | China | |
| Novartis Investigative Site | Tianjin | China | |
| Novartis Investigative Site | Tianjin | China | |
| Novartis Investigative Site | Ostrava | Poruba | |
| Novartis Investigative Site | Brno | 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 | Dresden | Saxony | |
| Novartis Investigative Site | Aachen | 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 | |
| Novartis Investigative Site | Avellino | AV | |
| Novartis Investigative Site | Florence | FI | |
| Novartis Investigative Site | Milan | MI | |
| Novartis Investigative Site | Roma | RM | |
| Novartis Investigative Site | Torino | TO | |
| Novartis Investigative Site | Bassano del Grappa | VI | |
| Novartis Investigative Site | Nagoya | Aichi-ken | |
| Novartis Investigative Site | Isehara | Kanagawa | |
| Novartis Investigative Site | Suwa | Nagano | |
| Novartis Investigative Site | Suita | Osaka |
+ 20 more sites — see the full list on the official registry below.
More Novartis Pharmaceuticals trials in South Korea
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04747613 on ClinicalTrials.gov ↗ ← All trials in South Korea