A One-Year, Randomized, Double-Blind, Placebo-Controlled Trial of Rosiglitazone in Non-Alcoholic Steatohepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- improvement in steatosis
研究概览
简要总结
This study is intended to find out whether treatment with rosiglitazone improves the state of the liver and related blood markers in patients with nonalcoholic steatohepatitis (NASH).
详细描述
Phase one : A double blind randomized placebo controlled trial of rosiglitazone
- 64 pts with biopsy proven NASH will be randomized to receive either rosiglitazone 8 mg/day or placebo for one year.
- after one year of treatment patients will undergo a liver biopsy then a 4 month follow off treatment
Primary endpoint: improvement of at least 30% of the histological score of steatosis Secondary endpoints: improvement in ALT values, in necrosis and inflammation and fibrosis
Phase II extension open label trial
All participants to the phase one regardless of the drug received in the first year will be treated with rosiglitazone for 2 additional years. A liver biopsy will be performed at the end of these two additional years in order to find out whether prolonged rosiglitazone therapy further results in improvement of liver injury in NASH patients.
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
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically proven NASH with steatosis >= 20%
- •Increased serum ALT
排除标准
- •bland steatosis
- •daily alcohol > 20/30 g (women/men)
- •any other cause of liver disease
- •secondary NASH including drug-induced steatohepatitis
- •treatment with insulin or glitazones
- •cardiac insufficiency
- •Hb < 10 g/dl
结局指标
主要结局
improvement in steatosis
次要结局
- improvement in transaminase levels; improvement/less worsening in necrosis and inflammatory activity and /or fibrosis