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
Фаза 3
Завершено
NCT05305664
| Заболевание | Hyperlipoproteinemia |
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| Фаза | Фаза 3 |
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| Спонсор | Novartis Pharmaceuticals |
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| Статус | Завершено |
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| Участники | 51 участн. |
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| Вмешательство | Pelacarsen (TQJ230) 80 mg s.c., Corresponding Placebo |
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| Дата начала | 19.08.2022 |
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| Дата завершения | 28.01.2025 |
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| Публикация результатов | 17.07.2026 |
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Кратко
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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