The Effect of Ezetimibe-Ursodiol Combination Therapy on Biomarkers of Liver Function and Sterol Balance in Subjects With NAFLD
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Reduction in Serum Alanine Transaminase (ALT)
研究概览
简要总结
The purpose of this research is to gather information on the combination Zetia® (Ezetimibe) and Urso Forte® with respect to sterol balance and their effects on biomarkers of liver function in subjects with nonalcoholic fatty liver disease (NAFLD).
详细描述
The study will be conducted as a prospective open label trial with pre- and post-treatment measures for all dependent variables. This trial will enroll subjects with a clinical diagnosis of nonalcoholic fatty liver disease (NAFLD) by magnetic resonance imaging (MRI), computed tomography (CT) or ultrasound, including those diagnosed with nonalcoholic steatohepatitis (NASH). Subjects will be consented, blood collected and a MRI conducted on the first visit. Patients will be advised on the proper use of the study drug and given the first three month's supply of the study drug to take home with them. For the remaining three months, study drug will be delivered by US mail along with return packaging for the prior three month's study medication in order to monitor compliance. Patients will be called routinely to encourage compliance, retention, and monitor side effects or adverse events. After six months of study drug administration, subjects will return for a follow-up visit. Blood will be drawn, an MRI will be obtained and a post-study questionnaire will be administered.
Duration of Patient Enrollment: 6 months Duration of Study: 18 months
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Steatosis
- •ALT >1.5 times normal
- •ALT/AST ratio >1.0
- •Normal Kidney Function
排除标准
- •Normal ALT within last 6 months
- •Advanced fibrosis based on 1) biopsy, if available (Stage 3 or 4 NAFLD), 2) imaging, or 3) lab (platelet count <150,000)
- •Daily alcohol use above 20 g/day for women and 30 g/day for men
- •Prescription use of ursodiol, ezetimibe, vitamin E, fish oils, thiazolidinediones, insulin, sulfonylureas, HMG-CoA reductase inhibitors
- •Weight loss greater than 15% in past 12 months
- •Pregnant or breastfeeding
- •Body Mass index greater than 50
- •Largest body circumference greater than 160 cm
- •Claustrophobia
- •Allergy to ezetimibe or ursodiol
研究组 & 干预措施
EZ-URSO Combination Therapy
Ursodiol (URSO Forte) 13-15 mg per kg (250-500 mg b.i.d. or t.i.d depending on body weight) combined with Ezetimibe (Zetia) 10 mg o.p.d.
干预措施: EZ-Urso combination therapy (Drug)
结局指标
主要结局
Reduction in Serum Alanine Transaminase (ALT)
时间窗: 6 months
Determine if Ezetimibe-Ursodiol combination therapy improves liver function tests (ALT)
次要结局
- Increase in Plasma Lathosterol(6 months)
- Reduction in Hepatic Fat Fraction(6 months)
研究者
Gregory Graf, PhD
PI
University of Kentucky