jRCT2031260071尚未招募不适用
A single arm, multicenter, open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants who completed the parent Lp(a)HORIZON trial (CTQJ230A12301E1)
未提供0 个研究点目标入组 100 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 100age old under(—)
- 性别
- All
入选标准
- •Participants who have provided informed consent prior to initiation of any study-specific activities/procedures.
- •Participants who have completed the parent study EOS visit while still on assigned investigational product.
排除标准
- •Participants who for any reason permanently discontinued or have interrupted the investigational product for continuous 6 months at EOS during the parent study.
- •Participants who have a history or evidence of any clinically significant disorder, condition, or disease that in the opinion of the investigator or Novartis physician (if consulted), would put the participant at risk or interfere with the study participation.
- •Participants are receiving another investigational drug or device before the open-label treatment period.
- •Participants have a known sensitivity to the study drug and are deemed as unsuited for the study by the Investigator at Screening visit.
研究者
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A single arm, open label extension (OLE), multicenter study to evaluate long-term safety and tolerability of pelacarsen (TQJ230) in patients with cardiovascular disease who have successfully completed the Frontiers Apheresis parent studyCTIS2023-503611-16-00ovartis Pharma AG60
