| Trial ID: | L0651 |
| Source ID: | EUCTR2012-000295-42-BE
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| Associated Drug: |
GFT505
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| Title: |
A Multicentre, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GFT505 once daily on Steatohepatitis in Patients with Non-Alcoholic Steatohepatitis (NASH).
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Patients with Non-Alcoholic Steatohepatitis (NASH) <br>MedDRA version: 14.1
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Nutritional and
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| Interventions: |
<br>Product Name: GFT505 40mg<br>Product Code: GFT505<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: Not applicable<br>CAS Number: 824932-88-9<br>Current Sponsor code: GFT505<br>Concentration unit: mg milligram(s)<br>Concentration type: equ
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| Outcome Measures: |
Main Objective: To evaluate the efficacy of GFT505 80mg and GFT505 120mg once daily for 52 weeks versus placebo in reversing histological steatohepatitis without worsening of fibrosis.<br>Worsening of fibrosis is evaluated using NASH CRN fibrosis staging system and defined as:<br>- Progression to stage 3 or 4 for patients at stage 0, 1 or 2 on diagnostic liver biopsy,<br>- Progression to stage 4 for patients at stage 3 on diagnostic liver biopsy.;Secondary Objective: - To evaluate the efficacy of GFT505 80mg and 120mg daily for 52 weeks vs. placebo in reversing histological steatohepatitis.<br>- To assess the improvement on NAS score.<br>- To assess the changes in individual histological scores of steatosis, and hepatic activity. <br>- To evaluate changes in area of fibrosis by morphometry.<br>- To assess changes in fibrosis by the NASH CRN fibrosis staging system.<br>- To assess changes in liver enzymes.<br>- To describe the changes in non-invasive markers of fibrosis and steatosis, in lipid parameters, in insulin resistance, in inflammatory markers, and in safety markers.<br>- To describe the variation in body weight.<br>- To evaluate the changes in cardiovascular risk profile.<br>- To determine PK parameters of GFT505 and GFT1007 after 52 weeks of treatment.<br>- To assess the tolerability and safety of daily administration of GFT505 80mg and 120mg for 52 weeks.<br>- To constitute a Biobank for discovery and validation of biomarkers in NASH/NAFLD and related diseases;Primary end point(s): Percentage of responders defined by the disappearance of steatohepatitis (i.e. patients no longer meeting the criteria for steatohepatitis) without worsening of fibrosis (evaluated using NASH CRN fibrosis staging system).;Timepoint(s) of evaluation of this end point: from Baseline to Week 52.Secondary end point(s): 1- Percentage of responders, defined by the disappearance of steatohepatitis (i.e. patients no longer meeting the criteria for steatohepatitis).
<br>2- Change in NAS score.
<br>3- Changes in stages of steatosis, hepatic activity (lobular inflammation + ballooning).
<br>4- Changes in stages of fibrosis (NASH CRN scoring).
<br>5- Changes in area of fibrosis by morphometry
<br>6- Changes in liver enzymes.
<br>7- Changes in non-invasive markers of fibrosis and steatosis.
<br>8- Changes in lipid parameters.
<br>9- Changes in body weight.
<br>10- Changes in insulin resistance.
<br>11- Changes in inflammatory markers.
<br>12- Changes in safety markers (renal or cardiac function parameters).
<br>13- Changes in cardiovascular risk profile.
<br>14- To determine PK parameters of GFT505 and GFT1007 after 52 weeks of treatment.
<br>15- SAE, AE, physical examination, vital signs, medical history, ECG.;Timepoint(s) of evaluation of this end point: End points n??1 to 13 will be measured from Baseline to week 52.
<br>
<br>End point n??14 will be measured at 2 time points post dosing at week 52.
<br>
<br>End point n??15:
<br>- collection of AE/SAE throughout the study ;
<br>- ECG at baseline, week 26 and week 52 ;
<br>- physical examination at each visit ;
<br>- vital signs at each visit.
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| Sponsor/Collaborators: |
GENFIT
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 2
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| Enrollment: |
270
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
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| Start Date: |
16/08/2012
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
22 August 2016
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| Locations: |
United States;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000295-42
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