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A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Rate of Weekly Lipoprotein Apheresis Sessions in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease in Germany
Sponsor: Novartis Pharmaceuticals
Summary
Phase III study to test the hypothesis that treatment with pelacarsen (TQJ230) 80 mg Q4W compared to placebo significantly reduces the rate of lipoprotein apheresis in patients with hyperlipoproteinemia (a) and established cardiovascular disease currently undergoing lipoprotein apheresis in Germany on a weekly schedule.
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Trial Assessing the Reduction of the Rate of Lipoprotein Apheresis After Treatment With Pelacarsen (TQJ230) Compared to Placebo in Patients With Hyperlipoproteinemia(a) and Established Cardiovascular Disease Undergoing Weekly Lipoprotein Apheresis in Germany
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
51
Start Date
2022-08-19
Completion Date
2025-01-28
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
Pelacarsen (TQJ230) 80 mg s.c.
Pelacarsen (TQJ230) 80 mg s.c. Q4W
Corresponding Placebo
Placebo to Pelacarsen
Locations (13)
Novartis Investigative Site
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Novartis Investigative Site
Munich, Bavaria, Germany
Novartis Investigative Site
Würzburg, Bavaria, Germany
Novartis Investigative Site
Frankfurt am Main, Hesse, Germany
Novartis Investigative Site
Göttingen, Lower Saxony, Germany
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany
Novartis Investigative Site
Geilenkirchen, North Rhine-Westphalia, Germany
Novartis Investigative Site
Dresden, Saxony, Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Cloppenburg, Germany
Novartis Investigative Site
Erlangen, Germany
Novartis Investigative Site
Mainz, Germany
Novartis Investigative Site
Ulm, Germany