Long Term Safety Study of PRALUENT

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追踪信息

首次提交日期 ^ICMJE

September 6, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 3, 2018

预计研究开始日期 ^ICMJE

September 28, 2018

预计主要完成日期

November 24, 2023 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Incidence of adverse events (AEs) after first administration of study drug through the last dose of study drug plus 2 weeks[ Time Frame: Up to week 192 ]

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Calculated low-density lipoprotein cholesterol (LDL-C) values from baseline over time[ Time Frame: Up to week 192 ]
Percent change in LDL-C from baseline over time[ Time Frame: Up to week 192 ]
Total cholesterol (Total-C) values from baseline over time[ Time Frame: Up to week 192 ]
Non-high-density lipoprotein cholesterol (non-HDL-C) values from baseline over time[ Time Frame: Up to week 192 ]
High-density lipoprotein cholesterol (HDL-C) values from baseline over time[ Time Frame: Up to week 192 ]
Triglyceride (TG) values from baseline over time[ Time Frame: Up to week 192 ]
Percent change from baseline in Total-C over time[ Time Frame: Up to week 192 ]
Percent change from baseline in non-HDL-C over time[ Time Frame: Up to week 192 ]
Percent change from baseline in HDL-C over time[ Time Frame: Up to week 192 ]
Percent change from baseline in TGs over time[ Time Frame: Up to week 192 ]
Gonadal hormone values from baseline over time[ Time Frame: Up to week 192 ]
Gonadotropin values from baseline over time[ Time Frame: Up to week 192 ]
Percent change from baseline in gonadal hormones over time[ Time Frame: Up to week 192 ]
Percent change from baseline in gonadotropins over time[ Time Frame: Up to week 192 ]
Alanine transaminase values from baseline over time[ Time Frame: Up to week 192 ]
Aspartate transferase values from baseline over time[ Time Frame: Up to week 192 ]
Alkaline phosphatase values from baseline over time[ Time Frame: Up to week 192 ]
Total bilirubin values from baseline over time[ Time Frame: Up to week 192 ]
Percent change from baseline in alanine transaminase over time[ Time Frame: Up to week 192 ]
Percent change from baseline in aspartate transferase over time[ Time Frame: Up to week 192 ]
Percent change from baseline in alkaline phosphatase over time[ Time Frame: Up to week 192 ]
Percent change from baseline in total bilirubin over time[ Time Frame: Up to week 192 ]

描述性信息

简略标题 ^ICMJE

Long Term Safety Study of PRALUENT

正式标题 ^ICMJE

Long Term Safety Study of PRALUENT in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk and Previously Enrolled in the Neurocognitive Function Trial

简要概况

The primary objective of the study is to evaluate the long term safety of PRALUENT in participants with heterozygous familial hypercholesterolemia (heFH) or non-familial hypercholesterolemia (FH) patients at high or very high cardiovascular risk who completed the neurocognitive function study (R727-CL-1532: NCT02957682). The secondary objectives of the study are: - To evaluate the effect of PRALUENT on low-density lipoprotein cholesterol (LDL-C) - To evaluate the effect of PRALUENT on other lipid parameters - To evaluate the effect of PRALUENT on gonadal steroid hormones

详细说明

研究类型 ^ICMJE

Interventional

研究阶段

Phase 4

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Drug: Praluent
Subcutaneous (SC) administration

研究工具

Experimental: Open label

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

1600

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

November 24, 2023

预计主要完成日期

November 24, 2023 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Key Inclusion Criteria: Participants randomized into the neurocognitive function study (R727-CL-1532) who completed treatment and the end of study (EOS) visit with no premature or permanent discontinuation of study drug. Key Exclusion Criteria: 1. Significant protocol deviation in the parent study (neurocognitive function study, R727-CL-1532: NCT02957682) based on the investigator's or sponsor's judgment, such as noncompliance 2. Any participant who experienced an AE leading to permanent discontinuation from the neurocognitive function study, (R727-CL-1532: NCT02957682). 3. Any new condition or worsening of an existing condition which, in the opinion of the investigator or per the PRALUENT local label, would make the participant unsuitable for enrollment or could interfere with the participant participating in or completing the open-label extension (OLE) study 4. Known hypersensitivity to monoclonal antibody or any component of the drug product 5. Pregnant or breastfeeding women Note: Other inclusion/ exclusion criteria apply

性别

参与研究的性别:

All

年龄

最小年龄：40 Years ，最大年龄：85 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: Yes
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

，

研究赞助商 ^ICMJE

Regeneron Pharmaceuticals

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Clinical Trial Management Regeneron Pharmaceuticals

PRS 账户

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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