NCT01950884Unknown4 期
A Randomised Controlled Trial of Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH
研究概览
简要总结
- NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver disease in Western countries (hepatic manifestation of insulin resistance);
- NAFLD represents a cardiovascular risk factor;
- Lifestyle modification(weight loss)is the effective medical treatment recommended for NASH (Non-alcoholic Steatohepatitis);
- Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.
详细描述
to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •1.Patients older 18 years
- •2.Histological diagnosis of possible or definite NASH, according to Kleiner scorw, within 6 months before randomization -
排除标准
- •Average alcohol consumption > 20 g per day in women and > 30 g per day in men
- •other causes of chronic liver disease 3) History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention 4)Hepatic cirrhosis with Child-Pugh score of B or C, and/or concomitant HCC 5)Recent(within 6 months) or concomitant use of agents known to cause hepatic steatosis 7)Recent(within 6 months)change in dose/regimen or first treatment with vitamin E, C, betaine, s-adenosylmethionine, ursodeoxycholate, sylimarin, fibrate, statin, pentoxyfilline, angiotensin II inhibitors, orlistat, sibutramine 8)Ongoing or recent therapy (within 6 months) with vitamin D or with medications known to affect vitamin D3 metabolism 9)Any additional condition that might interfere with optimal partecipation in the study, according to Investigators opinion; 10)Be pregnant or breastfeeding.
研究组 & 干预措施
Ezetimibe
Experimental
Ezetimibe tablets plus lifestyle
干预措施: Ezetimibe (Drug)
Ezetimibe
Experimental
Ezetimibe tablets plus lifestyle
干预措施: Lifestyle (Behavioral)
lifestyle
Active Comparator
lifestyle
干预措施: Lifestyle (Behavioral)
结局指标
主要结局
HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH
时间窗: 52 WEEKS
1. either improvement in NAS by at least 2 points spread across at least 2 of the NAS components or post-treatment NAS of 3 points or less; 2. at least 1 point improvement in the score for ballooning degeneration; 3. no worsening of the fibrosis score.
次要结局
- Changes in individual components of NAS score(6 weeks, 24 weeks, 52 weeks)
研究者
Maurizio R. Averna
MD
University of Palermo
研究点 (1)
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