Clinical Research Network in Nonalcoholic Steatohepatitis: Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 8
- 主要终点
- Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment.
研究概览
简要总结
The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).
详细描述
The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).
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
- 18 Years 至 —（Adult, Older Adult）
- 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
1
Pioglitazone
干预措施: Pioglitazone (Drug)
2
Vitamin E
干预措施: Vitamin E (Dietary Supplement)
3
Placebo Pioglitazone or Placebo Vitamin E
干预措施: Matching placebo (Drug)
结局指标
主要结局
Number of Participants With Improvement in Non-alcoholic Fatty Liver Disease (NAFLD) Activity Defined by Change in Standardized Scoring of Liver Biopsies at Baseline and After 96 Weeks of Treatment.
时间窗: baseline and 96 weeks
Total nonalcoholic fatty liver disease (NAFLD) activity was assessed on a scale of 0 to 8, with higher scores indicating more severe disease; the components of this measure include steatosis (assessed on a scale of 0 to 3), lobular inflammation (assessed on a scale of 0 to 3), and hepatocellular ballooning (assessed on a scale of 0 to 2). The primary outcome was an improvement in histological findings from baseline to 96 weeks, which required an improvement by 1 or more points in the hepatocellular ballooning score; no increase in the fibrosis score; and either a decrease in the activity score for nonalcoholic fatty liver disease to a score of 3 or less or a decrease in the activity score of at least 2 points, with at least a 1-point decrease in either the lobular inflammation or steatosis score.
次要结局
- Number of Participants With Improvement in Fibrosis(baseline and 96 weeks)
- Number of Participants With Improvement in Steatosis(baseline and 96 weeks)
- Number of Participants With Improvement in Hepatocellular Ballooning(baseline and 96 weeks)
- Number of Participants With Resolution of Definite Nonalcoholic Steatohepatitis(baseline and 96 weeks)
- Number of Participants With Improvement in Lobular Inflammation(baseline and 96 weeks)