EUCTR2017-003092-55-GB进行中（未招募）1 期
A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C (ORION-8) - Orion 8
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,700
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Subjects may be included if they meet all of the following inclusion criteria prior to entry into this study:
- •1.Completion of a previously qualifying Phase III lipid-lowering ORION feeder study [MDCO-PCS-17-03 (ORION-9), MDCO-PCS-17-04 (ORION-10) MDCO-PCS-17-08 (ORION-11), or MDCO-PCS 17-02 (ORION-5)], meaning the subject received the last dose of study drug and completed the final study visit per applicable protocol.
- •2.On current lipid-lowering therapies (such as a statin and/or ezetimibe) from previous study with no planned medication or dose change during study participation.
- •3.Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •Subjects will be excluded from the study if any of the following exclusion criteria apply immediately prior to entry into the study:
- •1.Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the subject at significant risk (according to investigator’s [or delegate’s] judgment) if he/she participates in the clinical study.
- •2.An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.
- •3.Severe concomitant noncardiovascular disease that carries the risk of reducing life expectancy to less than 3 years.
- •4.Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), >3x the upper limit of normal (ULN), or total bilirubin (TBIL) elevation >2x ULN at last recorded visit in the feeder study prior to study entry visit.
- •5.Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least one method of acceptable effective contraception (eg, oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device) for the entire duration of the study. Exemptions from this criterion:
- •a.Women >2 years postmenopausal (defined as 1 year or longer since their last menstrual period) AND more than 55 years of age
- •b.Postmenopausal women (as defined above) and less than 55 years old with a negative pregnancy test within 24 hours of enrollment
- •c.Women who are surgically sterilized at least 3 months prior to enrollment
- •6.Planned use of other investigational medicinal products other than inclisiran or devices during the course of the study.
- •7.Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:
- •a.Subjects who are unable to communicate or to cooperate with the investigator
- •b.Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency)
- •c.Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (eg, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study)
- •d.Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study
- •e.Persons directly involved in the conduct of the study
研究者
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