2025-521678-32-00招募中3 期
ADVANCE: A Phase III Multi-Centre, Randomised, Double-Blind, Double-Dummy Clinical Trial Comparing Essentiale® Liquid vs. Capsules for MASLD/MASH, Alcoholic Liver Disease, and Chronic Viral Hepatitis B
Opella Healthcare Group S.A.S.27 个研究点 分布在 3 个国家目标入组 466 人开始时间: 2025年9月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 466
- 试验地点
- 27
- 主要终点
- Changes in overall symptoms evaluation using the GOS score
研究概览
简要总结
Demonstrate clinical non-inferiority of Essentiale® EPL liquid 1800 mg on top of SoC compared to Essentiale® EPL oral capsule on top of SoC
研究设计
- 分配方式
- Randomized
- 主要目的
- Study
- 盲法
- Double (Subject, Investigator, Monitor, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Adult participants (18 to 70 years, inclusive)
- •Participants with symptoms (energy loss (asthenia), feeling depressed, abdominal pain/discomfort, fatigue, sleeping disorder, appetite loss and nausea) assessed by Global Overall Symptom (GOS) score either 3 or higher at baseline visit and at least one of the following chronic liver diseases based on physician diagnosis available at the baseline visit (which can be based on existing patient medical records/history): a) Metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH) b). Alcoholic liver disease (ALD) c). Chronic Viral Hepatitis B (HBV)
- •Participants receiving standard care for the pre-existing liver disease
- •Participants are willing not to consume alcohol and undergo alcohol withdrawal programme if they have a history of alcoholism, and are willing to implement diet control and exercise programme if required
- •Signed Informed Consent Form
- •Expressed willingness to comply with all trial procedures and availability for the duration of the trial
- •Ability to take oral therapy and be willing to adhere to the different interventions of this trial
- •Woman of childbearing potential (WOCBP) must agree to use at least one highly effective contraceptive method (hormonal contraceptives, IUD/IUS, or bilateral tubal occlusion) throughout the study and for 30 days after the last dose of trial intervention. Barrier methods (e.g., condoms) are acceptable only when combined with a highly effective method.
- •Male participants with partners of childbearing potential must use condoms in addition to their partner’s use of a highly effective contraceptive method during the study and for 30 days after the last dose.
排除标准
- •Hepatic cirrhosis within 3 months before the screening visit
- •Has been using Essentiale (or any similar EPL product) within 1 month before the participant enrolment visit
- •Use of OTC medicinal products and dietary supplements known to affect liver function, including milk thistle (silymarin), and other herbal or natural products with potential hepatoprotective effects, within 30 days prior to screening and throughout the study period
- •Is not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or potentially is at risk of non-compliance to trial procedures.
- •Drugs and/or alcohol abuse
- •Female participant of childbearing potential (WOCBP) without a negative pregnancy test result
- •Participants who are pregnant, lactating, or unable/unwilling to adhere to the required contraceptive measures
- •Hypersensitivity to Essentiale®, the IMP, their components or any of their excipients that, in the opinion of the Investigator, contraindicates participation in the trial.
- •Severe heart disease (e.g., heart failure), according to New York Heart Association 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
- •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 participant screening visit
- •Diagnosed with any of the following: a) Diagnosed with type 1 diabetes mellitus b) Gastroesophageal reflux disease c) Autoimmune hepatitis d) Fulminant hepatitis e) Diagnosis of cancer f) Parenteral nutrition
- •Is enrolled in another clinical trial or has taken other investigational drug(s) within 1 month before the participant enrolment visit
结局指标
主要结局
Changes in overall symptoms evaluation using the GOS score
Changes in overall symptoms evaluation using the GOS score
次要结局
- Changes in key individual symptoms using the GOS scale
- Change in CLDQ global score
- Incidence and severity of TEAEs
研究者
Science Hub
Scientific
Opella Healthcare Group S.A.S.
研究点 (27)
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