NCT00063635已完成3 期
Clinical Research Network in Nonalcoholic Steatohepatitis: Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)10 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2005年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 173
- 试验地点
- 10
- 主要终点
- Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L
研究概览
简要总结
The purpose of this study is to determine if therapeutic modification of insulin resistance or oxidative stress leads to improvement in serum or histologic indicators of liver injury or quality of life.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
3
Placebo Comparator
Matching placebo
干预措施: Matching placebo (Drug)
1
Active Comparator
Metformin, 500 mg, twice daily
干预措施: Metformin (Drug)
2
Active Comparator
Vitamin E, 400 IU, twice daily
干预措施: Vitamin E (Dietary Supplement)
结局指标
主要结局
Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L
时间窗: baseline and 96 weeks
The primary outcome was sustained reduction in ALT level, defined as 50% or less of the baseline level or 40 IU/L or less at each visit from 48 to 96 weeks of treatment.
次要结局
- Change in Body Mass Index(baseline and 96 weeks)
- Change in Serum Aspartate Aminotransferase (AST)(baseline and 96 weeks)
- Number of Participants With Improvement in Liver Fibrosis Score(baseline and 96 weeks)
- Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment(baseline and 96 weeks)
- Number of Participants With Improvement in Ballooning Degradation Score(baseline and 96 weeks)
- Number of Participants With Improvement in Steatosis Score(baseline and 96 weeks)
- Number of Participants With Improvement in Lobular Inflammation Score(baseline and 96 weeks)
- Change in Serum Vitamin E Levels(baseline and 96 weeks)
- Change in Quality of Life (QOL) Scores- Physical Health(baseline and 96 weeks)
- Change in QOL- Psychosocial Health(baseline and 96 weeks)
研究者
研究点 (10)
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