2023-503611-16-00进行中（未招募）3 期
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 study
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Adverse events (AEs) or serious adverse events (SAEs), laboratory evaluations, vital signs and duration of drug exposure
研究概览
简要总结
To evaluate long-term safety and tolerability of pelacarsen (TQJ230) in participants with elevated Lp(a) and established cardiovascular disease who have completed the parent study
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent must be obtained prior to participation in the OLE study and before any study’s assessment is performed
- •Participant has successfully completed the parent study and is considered safe to participate by Investigator's clinical judgement [In case of a premature study treatment permanent discontinuation from the parent study for medical/safety reasons prior to week 52, participant is not considered as having successfully completed the parent study]
排除标准
- •Any medical condition(s) that may put the participant at risk in the investigator’s opinion, or that the investigator deems unsuitable for the study
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly-effective methods of contraception during dosing and for 16 weeks (= 5 times the terminal half-life) after stopping of study medication. Such highly-effective contraception methods include: • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) total hysterectomy or bilateral tubal ligation at least six weeks before taking investigational drug. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment • Male sterilization (at least 6 months prior to screening). For female participants on the study, the vasectomized male partner should be the sole partner for that participant. • Use of oral, (estrogen and progesterone), injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking the investigational drug. Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms). Women are considered not of child-bearing potential if they are post-menopausal or have had surgical bilateral oophorectomy (with or without hysterectomy), total hysterectomy or bilateral tubal ligation at least six weeks prior to enrollment on study. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of childbearing potential
结局指标
主要结局
Adverse events (AEs) or serious adverse events (SAEs), laboratory evaluations, vital signs and duration of drug exposure
Adverse events (AEs) or serious adverse events (SAEs), laboratory evaluations, vital signs and duration of drug exposure
次要结局
- Number of lipoprotein apheresis sessions performed yearly for year 1, 2, 3, 4 and 5
- Absolute and percentage change in Lp(a) on month 1, month 3, month 6, month 9, month 12, then every 6 months during OLE compared to baseline of the parent study
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (9)
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