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])

Phase 1

• Conditions: on-alcoholic steatohepatitis (NASH); Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 24.1Level: PTClassification code 10053219Term: Non-alcoholic steatohepatitisSystem Organ Class: 10019805 - Hepatobiliary disorders

• Registration Number: EUCTR2018-003443-31-PL
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-09
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 363

Inclusion Criteria

• 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

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
• 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