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.
Status: Active_not_recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• Signed informed consent
• Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement.
Locations
Other Locations
Germany
Novartis Investigative Site
Berlin
Novartis Investigative Site
Cloppenburg
Novartis Investigative Site
Dresden
Novartis Investigative Site
Erlangen
Novartis Investigative Site
Frankfurt Am Main
Novartis Investigative Site
Mainz
Novartis Investigative Site
München
Novartis Investigative Site
Ulm
Novartis Investigative Site
Würzburg
Time Frame
Start Date: 2023-09-29
Completion Date: 2028-08-24
Participants
Target number of participants: 41
Treatments
Experimental: Pelacarsen (TQJ230)
open-label pelacarsen 80 mg
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals