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An Open Label Extension (OLE) Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230)
Sponsor: Novartis Pharmaceuticals
Summary
This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).
Official title: A Single Arm, Open Label Extension (OLE), Multicenter Study to Evaluate Long-term Safety and Tolerability of Pelacarsen (TQJ230) in Patients With Cardiovascular Disease Who Have Successfully Completed the Apheresis Parent Study.
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2023-09-29
Completion Date
2028-08-24
Last Updated
2025-08-06
Healthy Volunteers
No
Conditions
Interventions
Pelacarsen
Pelacarsen 80mg s.c. monthly
Locations (9)
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cloppenburg, Germany
Novartis Investigative Site
Dresden, Germany
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
München, Germany
Novartis Investigative Site
Ulm, Germany
Novartis Investigative Site
Würzburg, Germany