Beta Glucosylceramide for Treatment of Non Alcoholic Steatohepatitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol
研究概览
简要总结
Oral administration of betaglucosylceramide was shown effective in reducing inflammation in animal models and was found safe in humans.
详细描述
Patients with NASH to receive the treatment versus placebo for 40 weeks followed by a liver biopsy.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy proven NASH
排除标准
- •Other therapies
研究组 & 干预措施
Placebo
Normal saline administered orally daily as a placebo
干预措施: Placebo (Drug)
Beta Glucosylceramide
Beta glucosylceramide administered orally daily
干预措施: Beta Glucosylceramide (Drug)
结局指标
主要结局
Number of Participants With a Decrease of 2 Points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) Analysis is Per Protocol
时间窗: Total score from baseline compared with week 40.
Number of Participants who had a decrease of 2 points in the Non-Alcoholic Fatty Liver Disease Activity Score (NAS) from baseline at 40 weeks per protocol analysis. The score is performed on the liver biopsy before and after treatment. The total score is used with a range from 4-16. A decrease in the total score by 2 points or more is considered an improvement, while an increase in the total score by 2 points or more is considered deterioration. No use of subscales for the data analysis was made. Allparticipants in both arms who showed a decrease of 2 points or more in the Non-Alcoholic Fatty Liver Disease Activity Score are conisdered as responders. Only values quantifying data that were actually measured and analyzed are included.
次要结局
未报告次要终点