Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 363
- 试验地点
- 1
- 主要终点
- Number of participants with resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis AND/OR improvement of fibrosis, and no worsening of NAS
研究概览
简要总结
This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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
研究组 & 干预措施
norUrsodeoxycholic acid 1000 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg
干预措施: norUrsodeoxycholic acid (Drug)
norUrsodeoxycholic acid 1500 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg
干预措施: norUrsodeoxycholic acid (Drug)
Placebo to norUrsodeoxycholic acid
3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid
干预措施: norUrsodeoxycholic acid (Drug)
结局指标
主要结局
Number of participants with resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis AND/OR improvement of fibrosis, and no worsening of NAS
时间窗: 72 weeks
次要结局
未报告次要终点