Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
Phase 2
Completed
- Conditions
- on alcoholic steatohepatitis with fibrosis
- Registration Number
- JPRN-jRCT2080225223
- Lead Sponsor
- Pfizer R&D Japan G.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 350
Inclusion Criteria
Inclusion Criteria:
* Biopsy proven NASH with either F2 or F3 fibrosis, per NASH CRN definition
* BMI >/= 22.5kg/m2
Exclusion Criteria
Exclusion Criteria:
* Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
* Any condition possibly affecting drug absorption -Unstable concomitant medical conditions, based on medical history or screening laboratory results including-
* unstable liver function tests, recent cardiovascular event(s) significant malignancies,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method