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
3期
已完成
NCT05305664
| 适应症 | Hyperlipoproteinemia |
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| 分期 | 3期 |
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| 申办方 | Novartis Pharmaceuticals |
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| 状态 | 已完成 |
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| 受试者人数 | 51 人 |
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| 干预（药物） | Pelacarsen (TQJ230) 80 mg s.c., Corresponding Placebo |
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| 开始日期 | 2022年8月19日 |
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| 完成日期 | 2025年1月28日 |
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| 结果公布日 | 2026年7月17日 |
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摘要
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.
Rate of Lipoprotein Apheresis Sessions Performed Over 52 Weeks Normalized to the Weekly Lipoprotein Apheresis Schedule
Up to Week 52 · Apheresis sessions received per week
| Pelacarsen (TQJ230) | 0.16 Apheresis sessions received per week |
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| Placebo | 0.93 Apheresis sessions received per week |
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| p-value | <0.0001 |
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| Odds Ratio (OR) | 0.006 (95% CI 0.003–0.013) |
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