EUCTR2018-003443-31-DK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
相似试验
进行中（未招募）
1 期
Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acidprimary biliary cholangitisMedDRA version: 27.0Level: PTClassification code 10080429Term: Primary biliary cholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2021-001431-56-NODr. Falk Pharma GmbH90
进行中（未招募）
1 期
Clinical trial comparing the efficacy and safety of norursodeoxycholic acid tablets with placebo in the treatment of non-alcholic fatty liver disease with liver inflammation (non-alcoholic steatohepatitis[NASH])on-alcoholic steatohepatitis (NASH)MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2018-003443-31-HUDr. Falk Pharma GmbH363
进行中（未招募）
1 期
Clinical study comparing two doses of norucholic acid against placebo in the treatment of a liver disease called primary biliary cholangitis in patients without sufficient response to ursodeoxycholic acidEUCTR2021-001431-56-ATDr. Falk Pharma GmbH90
进行中（未招募）
1 期
Clinical trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisPrimary biliary cholangitisMedDRA version: 21.0Level: PTClassification code 10080429Term: Primary biliary cholangitisSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2020-001961-34-BEDr. Falk Pharma GmbH136
进行中（未招募）
不适用
Double-blind, randomised, placebo-controlled, phase III study comparing the efficacy and safety of bilastine 20 mg once daily and cetirizine 10 mg for the treatment of allergic allergic rhinitisEUCTR2004-004586-14-BEFAES FARMA S.A.790