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 Apheresis Parent Study.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Duration of drug exposure
研究概览
简要总结
This non-randomized, open-label extension study will provide post-trial access to pelacarsen (TQJ230) to participants in Germany with hyperlipoproteinemia(a) and established cardiovascular disease who have successfully completed the double-blind parent study (CTQJ230A12302).
详细描述
This study will allow to evaluate a long-term safety and tolerability of pelacarsen (TQJ230) 80 mg QM in patients. All consenting participants from the parent study who meet the eligibility criteria will be participating in this open label extension study. The maximum duration of this study is approximately 5 years.
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
- •Signed informed consent
- •Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement.
排除标准
- •Any medical condition(s) that may put the participant at risk in the investigator's opinion
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, unless they are using effective methods of contraception during dosing and for 16 weeks (= 5 times the terminal half-life) after stopping of study medication
研究组 & 干预措施
Pelacarsen (TQJ230)
open-label pelacarsen 80 mg
干预措施: Pelacarsen (Drug)
结局指标
主要结局
Duration of drug exposure
时间窗: 60 months
Duration of drug exposure will be collected
Incidence of Adverse events (AEs) or serious adverse events (SAEs), including changes in laboratory evaluations, vital signs qualifying and reported as AEs.
时间窗: 60 months
Evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have competed the parent study
次要结局
- Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5(60 months)
- Absolute change in Lp(a) compared to baseline of the parent study.(month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months))
- Percentage change in Lp(a) compared to baseline of the parent study.(month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE (up to 60 months))