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

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

ClinicalTrials.gov Identifier: NCT05305664

Novartis Reference Number: CTQJ230A12302

Last Update: Sep 22, 2022

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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.

Condition 
Hyperlipoproteinemia(a)
Phase 
Phase 3
Overall status 
Recruiting
Start date 
Aug 19, 2022
Completion date 
Sep 11, 2024
Gender 
All
Age(s)
18 Years - 80 Years (Adult, Older Adult)

Interventions

Drug
Pelacarsen (TQJ230) 80 mg s.c.
Pelacarsen (TQJ230) 80 mg s.c. Q4W
Drug
Corresponding Placebo
Placebo to Pelacarsen

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)

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

Study Locations

Germany
Novartis Investigative Site
Recruiting
Dresden, 01307
-
Germany
Novartis Investigative Site
Recruiting
Gottingen, 37075
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Recruiting
Muenchen, 81377
-
Germany
Novartis Investigative Site
Recruiting
Villingen-Schwenningen, D78052
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]