EUCTR2021-006069-39-DE进行中（未招募）1 期
A Randomized, Double-Blind, Parallel-Group Clinical Trial to Assess the Efficacy of Essentiale on Hepatic Steatosis Added to Standard of Care Versus Placebo Added to Standard of Care, in Non-Alcoholic Fatty Liver Disease (NAFLD) Associated with Type 2 Diabetes Mellitus (T2DM) and/or Hyperlipidemia and/or Obesity - Essentiale in NAFLD with T2DM and/or Hyperlipidemia and/or Obesity (EXCEL)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 190
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •- Is capable of understanding the written informed consent, provides signed written informed consent, is willing and able to complete the electronic diary (eDiary), and agrees to comply with protocol requirements.
- •- Is an adult male or female, 18 to 70 years (both inclusive) of age.
- •- Was diagnosed with NAFLD.
- •- Presents with steatosis score of S1–S3 (defined as CAP score >248 decibels per meter [dB/m], as measured by transient elastography).
- •- Presents with liver fibrosis score of F1–F3 (defined as LSM of 5-13 kilopascals [kPa], as measured by transient elastography)
- •- Has confirmed diagnosis of at least one of the following associated illnesses:
- •o T2DM and has been treated with diabetes medications (eg, metformin,
- •insulin) with stable doses for 3 months, as judged by the investigator,
- •before the patient enrollment visit, and is willing to continue their
- •medications during the trial.
- •o Hyperlipidemia (defined as presence of abnormally elevated levels of any
- •or all lipids or lipoproteins in the blood) and has been treated with
- •hyperlipidemia medications (eg, statins) with stable doses for 3 months, as judged by the investigator, before the patient enrollment visit, and is willing to continue their medications during the trial.
- •o Obesity (defined as body mass index [BMI] =30 kg/m2) *
- •*Body weight and height will be recorded for the calculation of BMI
- •(metric: BMI = weight (kg)/[height (m)]2).
- •- Is willing to follow lifestyle modification (diet and physical activity/exercise), as recommended by the investigator, and agrees to maintain these modifications during the trial period.
- •(Note: In order to encourage stable and sustainable lifestyle modification among patients during the conduct of this trial, sites will be encouraged to apply site - and disease-specific SOC or apply 2016 European Association for the Study of the Liver [EASL] guidelines (EASL et al 2016). In either case, SOC refers to lifestyle modification, whose common denominator across trial sites potentially could be summarized as a measure to decrease body fat and weight.)
- •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 135
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 55
排除标准
- •Patients meeting any of the following criteria (at the patient enrollment visit) will be excluded from the trial:
- •- Has other causes of liver disease or abnormal laboratory results (AST =4 × upper limit of normal [ULN], ALT =4 × ULN, bilirubin =2 × ULN), or cirrhosis within 3 months before the patient enrollment visit.
- •- Has current viral hepatitis.
- •- Has been diagnosed with type 1 diabetes mellitus (T1DM).
- •- Has an HbA1c >10.0% within 3 months before the patient enrollment visit.
- •- Has severe heart disease (eg, heart failure), according to New York Heart Association (NYHA) Functional Classification (Class II–IV; The Criteria Committee of the New York Heart Association 1994) or severe renal impairment, as defined by estimated glomerular filtration rate of <15 mL/min/1.73 m2.
- •- Has current or known history of drug abuse within 6 months before the patient enrollment visit.
- •- Has current or known history of alcohol consumption >20 g per day in women or >30 g per day in men.
- •- Is enrolled in another clinical trial or has taken other investigational drug(s) within
- •1 month before the patient enrollment visit.
- •- Is not suitable for participation, whatever the reason, as judged by the investigator,
- •including medical or clinical conditions, or potentially is at risk of noncompliance to trial procedures.
- •- Has hypersensitivity to Essentiale or its components or any of its excipients that, in
- •the opinion of the investigator, contraindicates participation in the trial.
研究者
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