EUCTR2018-003443-31-PL进行中（未招募）1 期
Double-blind, randomised, placebo-controlled, phase IIb trial on the efficacy and safety of norursodeoxycholic acid tablets in patients with non-alcoholic steatohepatitis (NASH) - Norursodeoxycholic acid vs. placebo in NASH
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 363
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Must be willing to participate in the study and provide written informed consent
- •Male or female patients = 18 and < 75 years
- •Centrally assessed histological evidence of NASH and liver fibrosis
- •Women of childbearing potential agree to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 298
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •Patients taking prohibited medications
- •Presence of liver cirrhosis
- •Type 1 diabetes or uncontrolled Type 2 diabetes
- •History or presence of any other significant concomitant liver diseases
- •History of liver transplantation
- •BMI >45 kg/m^2
- •Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases)
- •Abnormal renal function (glomerular filtration rate estimated from cystatin C < 30 ml/min) at screening visit
- •Any active malignant disease (except for basal cell carcinoma)
- •Existing or intended pregnancy or breast-feeding
研究者
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