A Multicenter, Randomized, Double-blind, Placebo-controlled,Phase 2 Study to Evaluate the Efficacy, Safety of MG in Patients With Alcoholic Fatty Liver Disease and Alcoholic Hepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- To evaluate ALT normalization
研究概览
简要总结
The Purpose of A Multicenter, Randomized, Double-blind, Placebo-controlled to Evaluate the Efficacy, Safety and Pharmacokinetics of MG in Patients With alcoholic Fatty Liver Disease and Alcoholic Hepatitis.
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
- ••Patients over 18, under 70 years of age
- •The chronic alcohol intake patients
- •Current the heavy drinker over 3month, Day the average alcohol consumption Male>=60g, Female>=40mg y-GTP increase Male>=75, Female>=35
- •Over 1.5 ratio of AST to ALT
- •Patients who have chronoc alcohol disease
排除标准
- •Patients who have liver disease with the cause different with the alcohol except
- •Patients who have pyridoxine allergy or history
- •Patients who are judged by investigator that participation of the study is difficult due to disease as follow; hepatic cirrhosis, Wilson's disease, malignant tumor, serious metabolic disease, severe renal disease, severe pulmonary disease, severe cardiovascular disease, severe nervous disease/psychiatric disorder, muscle disease and etc
- •Patients taking other investigational product within 90 days prior to the participation in the study.
- •Patients who has been taken any medications that could affect the treatment : hypoglycemic agents, colchicine, penicillamine, corticosteroids, ursodeoxycholic acid, pentoxifylline, lont-term use of NSAIDs, statins, neuroleptics, anti convulsive medications, high-dose acetaminophen(>=2.5g/day)
- •Patients who have received treatment that may affect liver function within 1 month prior to the participation in the study
- •Patient who considered ineligible for participation in the study as Investigator's judgment
研究组 & 干预措施
Placebo
enteric coated capsule
干预措施: Placebo /bid P.O (Drug)
MG 500mg
Metadoxine + garlic oil
干预措施: MG-1 (Drug)
Metadoxine 500mg
enteric coated capsule
干预措施: metadoxine (Drug)
结局指标
主要结局
To evaluate ALT normalization
时间窗: 14weeks
To evaluate ALT normalization assessed by comparing the percentage.
change in AST, ALT, total lab billirubin lab value
时间窗: 14weeks
To evaluate the efficacy of the MG on change in AST, ALT, total lab billirubin lab value assessed from baseline to 4, 8, 12 weeks in patients with Alcoholic fatty liver disease
Change from Baseline in AST at 14weeks
时间窗: 14Weeks
To evaluate the liver function to assess improvement of the MG on change in AST lab value assessed from baseline to 12 weeks in patients with Alcoholic fatty liver disease
Number of Participants with Adverse Events (Safety)
时间窗: 14weeks
Adverse Event: Physical examine, Lab test, Vital sign, ECG, symptom, start day and time, end day and time, severity, progress, outcome, relation with investigational product.
To evaluate AST normalization
时间窗: 14weeks
To evaluate AST normalization assessed by comparing the percentage.
次要结局
未报告次要终点