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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

NCT05305664

CompletedPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: Hyperlipoproteinemia(a)

Interventions: Pelacarsen (TQJ230) 80 mg s.c., Corresponding Placebo

Countries: Germany

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients currently undergoing lipoprotein apheresis for isolated Lp(a) on a weekly schedule in Germany for ≥ 12 months prior to screening with at least 40 sessions within the past 52 weeks prior to randomization
* Lipoprotein(a) (Lp(a))\> 60 mg/dL at screening
* Spontaneous prior myocardial infarction (MI): ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
* Ischemic stroke: ≥ 3 months from screening visit to ≤ 10 years prior to the screening visit, and/or
* Clinically significant symptomatic peripheral artery disease (PAD)
* Clinically significant symptomatic coronary artery disease (PAD)

Exclusion Criteria:

* Uncontrolled hypertension
* Heart failure New York Heart Association (NYHA) class IV
* History of malignancy of any organ system
* History of hemorrhagic stroke or other major bleeding
* Platelet count \<140,000 per mm3 at screening
* Active liver disease or hepatic dysfunction
* Significant kidney disease
* Pregnant or nursing women

Locations (13)

Villingen-Schwenningen, Baden-Wurttemberg, Germany
Munich, Bavaria, Germany
Würzburg, Bavaria, Germany
Frankfurt am Main, Hesse, Germany
Göttingen, Lower Saxony, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Geilenkirchen, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Berlin, Germany
Cloppenburg, Germany
Erlangen, Germany
Mainz, Germany
Ulm, Germany