NCT00668070已完成2 期
Protocol for a Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week Treatment, Adaptive Proof-of-principle Study of Twice Daily Oral Dosing of a Novel PDE4 Inhibitor (ASP9831) in Subjects With Non-alcoholic Steatohepatitis (NASH)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 114
- 主要终点
- ALT
研究概览
简要总结
The aim of this study is to explore the effect of a new drug (ASP9831) in patients with non-alcoholic steatohepatitis (NASH) by assessing clinical signs, laboratory data and biomarkers during a 12 week treatment period
详细描述
The study includes an open-label sub-study prior to the main study
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •NASH, histologically confirmed by a liver biopsy performed within 1 year prior to first dose and randomization
- •Elevated serum ALT levels
排除标准
- •Hepatic cirrhosis
- •Other known cause of liver disease
- •Uncontrolled diabetes mellitis type 2, i.e. HbA1c > 8.5%
- •Positive history of tuberculosis or a positive PPD skin test which is not explained by previous BCG vaccination
- •History of excessive alcohol abuse within 5 years prior to screening or a current average alcohol intake of more than 20 g/day (2 units) for females or more than 30 g/day (3 units) for males
- •Subject has used drugs associated with steatohepatitis within 6 months prior to screening (corticosteroids, high dose estrogens, methotrexate, amiodarone, anti-HIV drugs, tamoxifen)
研究组 & 干预措施
ASP9831 Low Dose
Experimental
干预措施: ASP9831 (Drug)
ASP9831 Higher Dose
Experimental
干预措施: ASP9831 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
ALT
时间窗: 12 Weeks
次要结局
未报告次要终点
研究者
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