NCT02510599已完成2 期
An Open Label, Proof of Principle Study to Evaluate the Efficacy and Safety of Solithromycin for the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis
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
- 10
- 试验地点
- 1
- 主要终点
- To evaluate effects on hepatic histology in patients with NASH
研究概览
简要总结
The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.
详细描述
Patients will be administered solithromycin for 13 weeks with regular safety visits and liver biopsies at baseline and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Histologic evidence of NASH based on liver biopsy obtained within 180 days
- •NAS> or = 5
- •Able to swallow capsules intact
排除标准
- •Symptoms of acute liver disease
- •Cirrhosis on liver biopsy
- •Positive HIV or Hepatitis tests
- •Primary Biliary Cirrhosis
- •Poorly controlled diabetes with HgA1C >8.5%
- •ALT >4-fold upper limit of normal
- •QTcF >450 msec
- •CrCl <40 mL/min
研究组 & 干预措施
Solithromycin
Experimental
Solithromycin 200 mg PO QD for 1 week, followed by 200 mg PO TIW for 12 weeks
干预措施: solithromycin (Drug)
结局指标
主要结局
To evaluate effects on hepatic histology in patients with NASH
时间窗: 13 weeks
Using the Nonalcoholic fatty liver disease (NAFLD) Activity Score (NAS)
次要结局
- Changes in inflammation on liver biopsy(13 weeks)
- Changes in Steatosis on liver biopsy(13 weeks)
- Changes in hepatocellular ballooning score on liver biopsy(13 weeks)
研究者
研究点 (1)
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