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])
- Conditions
- on-alcoholic steatohepatitis (NASH)MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2018-003443-31-DE
- Lead Sponsor
- Dr. Falk Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 363
• 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
• 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASH ;Secondary Objective: To study safety and tolerability (adverse events [AEs], laboratory parameters) of norUDCA;Primary end point(s): Resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis from baseline to EOT/withdrawal visit <br>AND/OR <br>Improvement of fibrosis, and no worsening of NAS from baseline to EOT/withdrawal visit <br>;Timepoint(s) of evaluation of this end point: week 72 (EOT)/withdrawal visit
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Improvement of NASH and no worsening of fibrosis from baseline to EOT/withdrawal <br>• Change in NAS from baseline to EOT/withdrawal visit<br>• ALT = 0.8 ULN at EOT/withdrawal visit;Timepoint(s) of evaluation of this end point: week 72 (EOT)/withdrawal visit