NL-OMON52186已完成2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Evinacumab in Patients with Severe Hypertriglyceridemia for the Prevention of Recurrent Acute Pancreatitis - R1500-HTG-20118 (ICON 0456/0418)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 8
研究概览
简要总结
Trial ended prematurely
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •A patient must meet the following criteria to be eligible for inclusion in the
- •1. Adults 18 to 80 years of age without FCS due to LPL loss of function
- •2. Documented history of 1 HTG-associated AP episode within 24 months of
- •screening (can be determined by study investigator; does not need to be
- •confirmed by independent adjudication committee).
- •3. Fasting serum TG value >880 mg/dL (10 mmol/L) on 2 occasions at least 2 days
- •apart determined during the screening period. Triglyceride measurement can be
- •repeated once for values >500 mg/dL (5.6 mmol/L) but <880 mg/dL (10 mmol/L)
- •Fasting serum TG value >500 mg/dL (5.6 mmol/L) determined during the screening
- •period in patients with a history of 2 or more HTGassociated AP episodes within
- •24 months of screening
- •Fasting serum TG value >500 mg/dL (5.6 mmol/L) determined during the screening
- •period and a documented fasted serum TG value >1000 mg/dL (11.3 mmol/L) and a
- •history of 1 or more HTG-associated AP episode(s) within 24 months of screening.
- •4. Stable dose of lipid-lowering therapy (>=8 weeks) and willingness to maintain
- •a stable regimen throughout the study
- •5. Body mass index >=18.0 and <=45.0 kg/m2
- •6. Compliance with a stable diet and exercise regimen at screening and
- •willingness to continue the diet through the end of the study
- •7. Willing and able to comply with clinic visits and study-related procedures
- •8. Provide informed consent signed by study patient or legally acceptable
- •representative
- •9. Able to understand and complete study-related questionnaires
排除标准
- •A patient who meets any of the following criteria will be excluded from the
- •1. Hospitalization for AP within 4 weeks of screening
- •2. Known genetic FCS defined as homozygous or compound heterozygous LoF
- •mutations in LPL, as documented by prior genotype result or determined from FCS
- •genotyping at screening (see Section 9.2.7).
- •3. Symptomatic gallstone disease within 6 months prior to screening. Incidental
- •and/or asymptomatic gallstones are permitted. Patients with symptomatic
- •gallstone disease in the past 6 months who have undergone cholecystectomy >3
- •months prior to screening are permitted.
- •4. Use of any medication or nutraceutical known to alter serum lipids which has
- •not been part of a stable therapeutic regimen for at least 8 weeks, and there
- •are no plans to change the regimen during the study
- •5. Presence of any clinically significant, uncontrolled endocrine disease known
- •to influence serum lipids, including but not limited to:
- •a. Newly diagnosed (within 3 months) diabetes by medical history, including
- •screening value glycosylated hemoglobin (HbA1c) >6.5% without a prior history
- •of diabetes
- •b. Diabetes with HbA1c >10.0%
- •c. Thyroid disease with thyroid-stimulating hormone (TSH) normal (LLN) or >1.5x ULN
- •d. Thyroid replacement therapy that has not been stable for at least 12 weeks
- •Note: For laboratory values, 1 repeat measurement is allowed. Other laboratory
- •values that meet the inclusion/exclusion criteria do not need to be repeated.
- •6. Use of estrogen or testosterone therapy unless the regimen has been stable
- •in the past 6 weeks and there are no plans to change the regimen during the
- •7. Any clinically significant abnormality identified at the time of screening
- •that, in the judgment of the investigator or any sub-investigator, would
- •preclude safe completion of the study or constrain endpoints assessment; eg,
- •major systemic diseases, patients with short life expectancy, or considered by
- •the investigator or any sub-investigator as inappropriate for this study for
- •any reason, including but not limited to:
- •a. Deemed unable to meet specific protocol requirements, such as scheduled
- •b. Deemed unable to tolerate injections, as per the patient or the investigator
- •c. Part of a vulnerable population such as the institutionalized
- •d. Presence of any other conditions (eg, geographic or social), either actual
- •or anticipated, that the investigator feels would restrict or limit the
- •patient*s participation for the duration of the study
- •8. Laboratory findings (for the reason that patients with these findings, who
- •have a higher likelihood of liver, muscle, or kidney adverse events regardless
- •of treatment assignment, are expected to be rare, they may not be evenly
- •distributed across treatment groups and thus may confound the analysis of
- •a. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 according to
- •4 variable Modification of Diet in Renal Disease study equation (MDRD,
- •calculated by central laboratory)
- •b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3x ULN at
- •c. Creatine phosphokinase (CPK) >3x ULN at screening
- •Note: For all laboratory values, 1 repeat measurement is allowed.
- •9. Systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg at
- •the screening
研究者
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