Non-alcoholic steatohepatitis (NASH) MedDRA version: 20.0 Level: SOC Classification code 10019805 Term: Hepatobiliary disorders System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Product Name: Norursodeoxycholic acid (NorUDCA)
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Product Name: Norursodeoxycholi
Sponsors
Dr. Falk Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Must be willing to participate in the study and provide written informed consent • Male or female patients = 18 and 0.8 upper limit of normal (ULN) • 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: 0 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principal objective is to evaluate the efficacy of norursodeoxycholic acid (norUDCA) 1500 mg vs. norUDCA 1000 mg vs. placebo for the treatment of NASH.;Secondary Objective: The secondary objectives are to study the safety and tolerability (nonoccurence of side effects or abnormal 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 AND/OR Improvement of fibrosis, and no worsening of NAS from baseline to EOT/withdrawal visit;Timepoint(s) of evaluation of this end point: Week 72 (EOT)/withdrawal visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Improvement of NASH and no worsening of fibrosis from baseline to EOT/withdrawal • Change in NAS from baseline to EOT/withdrawal visit • ALT = 0.8 ULN at EOT/withdrawal visit;Timepoint(s) of evaluation of this end point: Week 72 (EOT)/withdrawal visit | — |
Countries
Austria, Belgium, Czech Republic, Germany, Greece, Hungary, Ireland, Latvia, Netherlands, Poland, Spain, Switzerland, United Kingdom
Contacts
Public ContactDepartment of Clinical Research
Dr. Falk Pharma GmbH
Outcome results
None listed