| Trial ID: | L0269 |
| Source ID: | NCT05083390
|
| Associated Drug: |
Ursodeoxycholic acid
|
| Title: |
Norursodeoxycholic Acid vs. Placebo in NASH
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: norUrsodeoxycholic acid
|
| Outcome Measures: |
Number of participants with resolution of NASH, assessed by centrally scored liver histology, and no worsening of fibrosis AND/OR improvement of fibrosis, and no worsening of NAS
|
| Sponsor/Collaborators: |
Dr. Falk Pharma GmbH
|
| Gender: |
All
|
| Age: |
18 Years to 74 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 2
|
| Enrollment: |
363
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
July 8, 2019
|
| Completion Date: |
April 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 27, 2021
|
| Locations: |
Medical University of Vienna, Department of Internal Medicine III, Vienna, Austria
|
| URL: |
https://ClinicalTrials.gov/show/NCT05083390
|
