NCT01754714已完成3 期
Open-label, Randomized, Parallel-Group, Exploratory Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Non-treated Matched Healthy Volunteers as Control Group
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 108
- 试验地点
- 32
- 主要终点
- Methionine Elimination Half-life Measured in Blood.
研究概览
简要总结
Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1000 mg SAMe (S-adenosyl-L-methionine)
Experimental
干预措施: SAMe 1000 mg (Drug)
1500 mg SAMe
Experimental
干预措施: SAMe 1500 mg (Drug)
2000 mg SAMe
Experimental
干预措施: SAMe 2000 mg (Drug)
结局指标
主要结局
Methionine Elimination Half-life Measured in Blood.
时间窗: 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
次要结局
- Metabolic Panel (Metabolic Laboratory Parameters)(change from baseline at 6 weeks)
- The Metabolic Clearance Rate Measured in the Blood.(0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*)
- 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test(0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*)
- Methionine Volume of Distribution at Week 7 (L)(0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*)
- Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve(0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*)
- Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.(0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*)
- Hepatic Panel (Liver Laboratory Parameters)(change from baseline at 6 weeks)
- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)(change from baseline at 6 weeks)
- Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)(change from baseline at 6 weeks)
研究者
研究点 (32)
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