EUCTR2018-003443-31-HU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 trial comparing the efficacy and safety of Rhudex granules with placebo in the treatment of the liver disease Primary Biliary CholangitisPrimary biliary cholangitisMedDRA version: 20.0Level: SOCClassification code 10019805Term: Hepatobiliary disordersSystem Organ Class: 10019805 - Hepatobiliary disordersEUCTR2020-001961-34-ITDR. FALK PHARMA GMBH136
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-HUDr. Falk Pharma GmbH136
进行中（未招募）
1 期
Double-blinded (treatment group unknown to physician and patient), randomised (treatment group allocated by chance) phase II trial on the efficacy and tolerability of an 8 week treatment with two different doses of budesonide tablets dissolving in the mouth compared to placebo (medication without active substance), for prevention of constrictions of the oesophagus in adult patients after removal of cancer tissue using an endoscopic surgery techniqueEUCTR2018-002617-35-DEDr. 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）
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-DEDr. Falk Pharma GmbH90