Double-blind, Randomised, Placebo-controlled, Phase IIb Trial on the Efficacy and Safety of Norursodeoxycholic Acid Tablets in Patients With Non-alcoholic Steatohepatitis (NASH)
Who is this study for? Patients with Nonalcoholic Steatohepatitis
What treatments are being studied? Norursodeoxycholic Acid
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This is a double-blind, randomised, multi-centre, placebo-controlled, comparative, phase IIb trial. The trial will be conducted with three treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d or 1000 mg/d norUDCA tablets vs. placebo tablets for the treatment of NASH.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Austria
Medical University of Vienna, Department of Internal Medicine III
RECRUITING
Vienna
Contact Information
Primary
Michael Stiess, PhD
zentrale@drfalkpharma.de
++49-761-1514
Time Frame
Start Date: 2019-07-08
Estimated Completion Date: 2025-04
Participants
Target number of participants: 363
Treatments
Experimental: norUrsodeoxycholic acid 1500 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg
Experimental: norUrsodeoxycholic acid 1000 mg/day
3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1000 mg
Placebo_comparator: Placebo to norUrsodeoxycholic acid
3 film-coated tablets once daily for 72 weeks containing placebo to norUrsodeoxycholic acid
Related Therapeutic Areas
Sponsors
Leads: Dr. Falk Pharma GmbH