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COMPLETED
NCT05305664
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Pelacarsen (TQJ230) 80 mg s.c.

Pelacarsen (TQJ230) 80 mg s.c. Q4W

DRUG

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