| Trial ID: | L0535 |
| Source ID: | ISRCTN57849521
|
| Associated Drug: |
Losartan
|
| Title: |
A randomised controlled trial of losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Fibrosis resulting from non-alcoholic steatohepatitis <br>Digestive System <br>Other diseases of liver
|
| Interventions: |
Treatment group: losartan orally, 50 mg capsule once a day for 24 months.<br>Control group: matched placebo orally, 1 capsule daily for 24 months.
|
| Outcome Measures: |
Kleiner fibrosis score, based on histological fibrosis stage at trial entry and end of study (96 weeks)1. Measurement of change in fibroscan score performed at trial entry, 48 weeks and end of study <br>2. Serological (Enhanced Liver Fibrosis test [ELF??? test]) markers of fibrosis performed at trial entry, 48 weeks and end of study <br>3. Change in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) from baseline, determined by liver biopsy at trial entry and end of study
|
| Sponsor/Collaborators: |
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
|
| Gender: |
All
|
| Age: |
nannan
|
| Phases: |
Phase 3
|
| Enrollment: |
214
|
| Study Type: |
Interventional
|
| Study Designs: |
Randomised parallel-group double-blind placebo-controlled study (Treatment)
|
| Start Date: |
12/10/2009
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
22 May 2017
|
| Locations: |
United Kingdom
|
| URL: |
http://isrctn.com/ISRCTN57849521
|
