Status:
COMPLETED
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Hyperlipoproteinemia(a)
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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 hyperlipoproteinem...
Detailed Description
Lipoprotein apheresis to date is the only approved therapeutic option for cardiovascular (CV) risk reduction in patients with severely elevated Lp(a) levels in Germany. Lipoprotein apheresis is an exp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05305664
Start Date
August 19 2022
End Date
January 28 2025
Last Update
February 14 2025
Active Locations (13)
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1
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany, 42010
2
Novartis Investigative Site
Geilenkirchen, North Rhine-Westphalia, Germany, 52511
3
Novartis Investigative Site
Berlin, Germany, 13353
4
Novartis Investigative Site
Cloppenburg, Germany, 49661