| Trial ID: | L0403 |
| Source ID: | NCT04679376
|
| Associated Drug: |
Statins
|
| Title: |
A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Statins in Adult Patients With Non-Alcoholic Steatohepatitis (NASH)
|
| Acronym: |
STAT NASH
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
NASH - Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Atorvastatin (40 mg daily);Other: Placebo
|
| Outcome Measures: |
Change in NASH as measured by improvement in NAS score Improvement in NAS score (= 2 points) with no worsening in fibrosis stage (=1 point) OR improvement in fibrosis with no worsening of NASH (change in the NAS score of = 0 points).NASH resolution as measured by (diagnosis by pathologist) (from definite- to not- NASH).....;Change in fibrosis stage as measured by change in stage;Change in each component of NASH histologic features as measured by presence or ab presence or absence of features or their severity.;Change in serum aminotransferase (ALT) and aspartate aminotransferase (AST) levels as measured by plasma concentrations;Change in makers of hepatic fibrosis markers as measured by (FIB-4,51 liver stiffness by Fibroscan??);Change in capture attention parameter (CAP) score (with Fibroscan??);Serum creatine phosphokinase (CPK) as measured by serum concentration;Change in serum lipids as measured by serum concentration
|
| Sponsor/Collaborators: |
Duke University
|
| Gender: |
All
|
| Age: |
18 Years70 Years
|
| Phases: |
Phase 2
|
| Enrollment: |
70
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
|
| Start Date: |
17/12/2020
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
27 September 2021
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04679376
|
