| Trial ID: | L0674 |
| Source ID: | EUCTR2009-015166-62-GB
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| Associated Drug: |
Losartan
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| Title: |
A randomised controlled trial of Losartan as an anti-fibrotic agent in non-alcoholic steatohepatitis. - Fibrosis Effects of Losartan in Nash Evaluation Study- FELINE
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
Has Results
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| Results: |
https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-015166-62/results
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| Conditions: |
Fibrosis in patients with non-alcoholic steatohepatitis. <br>
MedDRA version: 14.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Clas
|
| Interventions: |
<br> Trade Name: Cozaar<br> Product Name: Losartan<br> Pharmaceutical Form: Tablet<br> INN or Proposed INN: Losartan Potassium<br> CAS Number: 114798-26-4<br> Other
|
| Outcome Measures: |
Primary end point(s): 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 (ie. 96 weeks follow-up).;Main Objective: The principal research question/objective is to determine whether Losartan, taken as a tablet (50mg once a day) versus a dummy pill (which will look exactly the same as the real medication) is effective at slowing down, halting or reversing liver fibrosis (scar tissue) in patients with non-alcoholic steatohepatitis.;Secondary Objective: The secondary research questions/objectives are: 1. to determine whether Losartan can prevent clinical deterioration in NASH, or impact on the quality of life. 2. to show any changes in serum (blood sample), radiological (fibroscan) or histological (liver tissue) samples giving an indication to disease progression. 3. to measure the change in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) from baseline. 4. to note responder rate for placebo versus intervention.;Timepoint(s) of evaluation of this end point: This endpoint measured at visit 8 (96 weeks).Secondary end point(s): Secondary outcomes are: changes in radiological (Fibroscan) assessment. changes in serological (Enhanced Liver Fibrosis - ELF and Fibromax). change in non-alcoholic fatty liver disease (NAFLD) activity score (NAS) - determined by liver biopsy.;Timepoint(s) of evaluation of this end point: This endpoint measured at visit 1 (screening), 48 & 96 weeks. NAS (liver biopsy) measured prior to study entry and at 96 weeks.
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| Sponsor/Collaborators: |
Newcastle upon Tyne Hospitals NHS Foundation Trust
|
| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 3
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| Enrollment: |
214
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
<br> Controlled: yes<br> Randomised: yes<br> Open: no<br> Single blind: no<br> Double blind: yes<br> Parallel group: yes<br> Cross over: no<br>
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| Start Date: |
08/10/2010
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| Completion Date: |
31/12/2014
|
| Results First Posted: |
04/08/2016
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| Last Update Posted: |
30 June 2019
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| Locations: |
United Kingdom
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-015166-62
|
