NCT07517263招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 5,700
- 试验地点
- 892
研究概览
简要总结
This open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed the double-blind parent study (CTQJ230A12301).
详细描述
This study will evaluate long-term safety and tolerability of pelacarsen (TQJ230) 80 mg Once a month (QM) in participants with established cardiovascular disease and elevated Lp(a) who completed the parent study (CTQJ230A12301).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label study
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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, including, but not restricted to conditions outlined in Table 6-3 and Table 6-
- •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.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Pelacarsen (TQJ230)
Experimental
open-label pelacarsen 80mg
干预措施: Pelacarsen (TQJ230) (Drug)
研究者
研究点 (892)
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