| Trial ID: | L0267 |
| Source ID: | NCT01051219
|
| Associated Drug: |
Losartan
|
| Title: |
Anti-Fibrotic Effects of Losartan In Nash Evaluation Study
|
| Acronym: |
FELINE
|
| Status: |
Completed
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis
|
| Interventions: |
Drug: Losartan
|
| Outcome Measures: |
The primary outcome will be change in Kleiner fibrosis score, [Kleiner DE et al Hepatology 2005], based on histological fibrosis stage (as judged by two independent blinded histopathologists from liver biopsies), from pre-treatment to end-of-study|Change in radiological (fibroscan) and serological (ELF) markers of fibrosis|change in NAFLD activity score (NAS)|comparison of "responder rate" - placebo versus intervention
|
| Sponsor/Collaborators: |
Newcastle-upon-Tyne Hospitals NHS Trust|Newcastle University
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 3
|
| Enrollment: |
45
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
May 2011
|
| Completion Date: |
December 2014
|
| Results First Posted: |
--
|
| Last Update Posted: |
October 7, 2015
|
| Locations: |
Plymouth Hospitals NHS Trust, Plymouth, Devon, United Kingdom|Queen Elizabeth Hospital, Birmingham, United Kingdom|Cambridge University NHS Foundation Trust, Cambridge, United Kingdom|Royal Derby Hospital, Derby, United Kingdom|Royal Liverpool & Broadgreen University Hospital, Liverpool, United Kingdom|Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom|Imperial College (St Mary's Site), London, United Kingdom|St George's Hospital, London, United Kingdom|Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom|Queens Medical Centre, Nottingham, United Kingdom
|
| URL: |
https://ClinicalTrials.gov/show/NCT01051219
|
