Exploratory, Interventional, Open-label, Fixed-dose Study With Selincro® As-needed Use, in Alcohol Dependent Patients With Liver Impairment
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)
研究概览
简要总结
The purpose of this study is to explore the treatment effects of Selincro in alcohol dependent patients with liver impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has alcohol dependence, diagnosed at screening according to DSM-IV-TR™
- •The patient has had an average alcohol consumption at, at least, a high drinking risk level (that is >60 g of alcohol/day for men and >40 g of alcohol/day for women) in the 4 weeks preceding the Screening Visit and in the period between the Screening and Inclusion Visits (that is, in the Screening Period)
- •The patient has liver impairment defined by elevated liver stiffness and elevated liver enzymes at the Screening Visit (both criteria have to be fulfilled): liver stiffness (LS) as measured by Fibroscan >6 kPa, elevated transaminases (AST or ALT). Transaminase levels up to 5 times the upper limit of the reference range and γGT levels up to 10 times the upper limit of the reference range are allowed. At the discretion of the investigator, transaminase levels >5 times the upper limit of the reference range and γGT >10 times the upper limit of the reference range can be allowed if considered habitual for the patient, either confirmed by patient records or a repeat measurement during the Screening Period
- •The patient has a breath alcohol concentration (BrAC) <0.02% at the Screening Visit.
- •The patient provides a stable address and telephone number
- •The patient is a man or woman, aged ≥ 18 years
- •The patient has BMI≤30 kg/m2
排除标准
- •The patient has any psychiatric disorder or Axis I disorder (DSM-IV-TR™ criteria), established as the primary diagnosis, other than alcohol dependence assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview , that in any way will interfere with the ability of the patient to take part in the study
- •The patient has reported current use of, or has been tested positive for, drugs of abuse (opiates, methadone, cocaine, amphetamines [including ecstasy], barbiturates)
- •The patient has severe liver impairment classified with a Child-Pugh Score C
- •The patient has one or more clinical laboratory test values outside the reference range, based on the blood and urine samples taken at the Screening Visit, that are of potential risk to the patient's safety, or the patient has: Severe renal impairment (eGFR <30 mL/min per 1.73 m2), and/or Hypercholesterolemia with serum cholesterol levels > 300 mg/dL, (>7,758 mmol/L), and/or bilirubin > 3 mg/dL (50 μmol/L)
- •The patient has had <6 heavy drinking days (HDDs, defined by the European Medicines Agency as a day with an alcohol consumption >60 g for men or >40 g for women) in the 4 weeks preceding the Screening Visit
- •The patient has >5 consecutive abstinence days in the 4 weeks preceding the Screening Visit
- •The patient has a recent history of acute alcohol withdrawal syndrome (including hallucinations, seizures, or delirium tremens)
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
Selincro® (nalmefene) 18 mg, tablets
One tablet orally for 12 weeks on days when the patient perceives a risk of drinking alcohol, preferably 1-2 hours prior to the anticipated risk of drinking.
干预措施: nalmefene (Drug)
结局指标
主要结局
Change from baseline in the number of heavy drinking days per month (HDDs) (days/month)
时间窗: Baseline to months 1, 2 and 3
Change from baseline in the number of HDDs per week (days/week)
时间窗: Baseline to weeks 1 and 2
Change from baseline in total alcohol consumption (TAC) (g alcohol/day)
时间窗: Baseline to months 1, 2 and 3
Change from baseline in TAC (g alcohol/day)
时间窗: Baseline to weeks 1 and 2
Response Shift Drinking Risk Level (RSDRL)
时间窗: Baseline to month 3
Defined as a downward shift from baseline in drinking risk level (DRL); for patients with a very high DRL at baseline, a shift to medium DRL or lower; for patients with a high DRL at baseline, a shift to low DRL or below
Category shift in fibrosis stage
时间窗: Baseline to weeks 1,2 4, and 12
Change in transaminases and γ-glutamyl transferase (γGT)
时间窗: Baseline to weeks 1,2,4,8, and 12
Response Low Drinking Risk Level (RLDRL)
时间窗: Baseline to month 3
Defined as a downward shift from baseline in DRL to low DRL or below
Response defined as 0 to 4 HDDs (days/month)
时间窗: Month 3
Change in the Short-Form 36-Item Health Survey (SF-36)
时间窗: Baseline to week 12
Change in liver stiffness
时间窗: Baseline to weeks 1,2 4 and 12
Number of adverse events
时间窗: Screening to week 14
Change in bilirubin, albumin, and International Normalized Ratio (INR)
时间窗: Baseline to weeks 1,2,4,8, and 12
Response defined as ≥70% reduction in TAC
时间窗: Baseline to month 3
Clinical Global Impression, global improvement (CGI-I).
时间窗: Weeks 4 and 12
Change from baseline in Clinical Global Impression, Severity of illness (CGI-S)
时间窗: Baseline to weeks 4 and 12
次要结局
未报告次要终点