NL-OMON48935已完成3 期
A placebo-controlled, double-blind, randomized trial to evaluate the effect of 300 mg of inclisiran sodium given as subcutaneous injections in subjects with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDL-C) - MDCO-PCS-17-03 (ORION-9)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 38
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Subjects may be included in the study if they meet all of the following
- •1. Male or female subjects *18 years of age.
- •2. History of HeFH with a diagnosis of HeFH by genetic testing; and/or a
- •documented history of untreated LDL-C of >190 mg/dL, and a family history of
- •FH, elevated cholesterol or early heart disease may indicate FH
- •3. Stable on a low-fat diet (eg, NCEP)
- •4. Serum LDL-C *2.6 mmol/L (*100 mg/dL) at screening
- •5. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
- •6. Calculated glomerular filtration rate >30 mL/min by estimated glomerular
- •filtration rate (eGFR) using standardized clinical methodology.
- •7. Subjects on statins should be receiving a maximally tolerated dose. Maximum
- •tolerated dose is defined as the maximum dose of statin that can be taken on a
- •regular basis without intolerable adverse events. Intolerance to any dose of
- •any statin must be documented as historical AEs attributed to the statin in
- •question in the source documentation and on the Medical History page of the
- •electronic case report form (eCRF)
- •8. Subjects not receiving statin must have documented evidence of intolerance
- •to all doses of at least two different statins
- •9. Subjects on lipid-lower therapies (such as a statin and/or ezetimibe) should
- •be on a stable dose for *30 days before screening with no planned medication or
- •dose change during study participation.
- •10. Subjects must be willing and able to give informed consent before
- •initiation of any study-related procedures and willing to comply with all
- •required study procedures.
排除标准
- •Subjects will be excluded from the study if any of the following exclusion
- •criteria apply prior to randomization:
- •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]
- •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. New York Heart Association (NYHA) class IV heart failure or last known left
- •ventricular ejection fraction <25%.
- •4. Cardiac arrhythmia within 3 months prior to randomization that is not
- •controlled by medication or via ablation.
- •5. Major adverse cardiovascular event within 3 months prior to randomization.
- •6. Uncontrolled severe hypertension: systolic blood pressure >180 mmHg or
- •diastolic blood pressure >110 mmHg prior to randomization despite
- •anti-hypertensive therapy.
- •7. 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 >2x ULN at screening confirmed by a repeat
- •abnormal measurement at least 1 week apart.
- •8. Severe concomitant noncardiovascular disease that carries the risk of
- •reducing life expectancy to less than 2 years.
- •9. History of malignancy that required surgery (excluding local and wide-local
- •excision), radiation therapy and/or systemic therapy during
- •the three years prior to randomization.
- •10. Females who are pregnant or nursing, or who are of childbearing potential
- •and unwilling to use at least two methods of highly effective
- •contraception (failure rate less than 1% per year) (eg, combined oral
- •contraceptives, barrier methods, approved contraceptive implant, longterm
- •injectable contraception, or 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 last
- •menstrual period) AND more than 55 years of age.
- •b. Postmenopausal women (as defined above) and less than 55 years of age with a
- •negative pregnancy test within 24 hours of randomization.
- •c. Women who are surgically sterilized at least 3 months prior to enrollment.
- •11. Males who are unwilling to use an acceptable method of birth control during
- •the entire study period (ie, condom with spermicide).
- •12. Known history of alcohol and/or drug abuse within the last 5 years.
- •13. Treatment with other investigational products or devices within 30 days or
- •five half-lives of the screening visit, whichever is longer.
- •14. Planned use of other investigational products or devices during the course
- •of the study.
- •15. 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
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