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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02704403
Registration number
NCT02704403
Ethics application status
Date submitted
16/02/2016
Date registered
10/03/2016
Date last updated
23/03/2022
Titles & IDs
Public title
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients With Nonalcoholic Steatohepatitis (NASH) and Fibrosis
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Secondary ID [1]
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2015-005385-38
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Secondary ID [2]
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GFT505-315-1
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Universal Trial Number (UTN)
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Trial acronym
RESOLVE-IT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
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0
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Condition category
Condition code
Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
0
0
0
0
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Metabolic disorders
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Diet and Nutrition
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0
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0
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Obesity
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Inflammatory and Immune System
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0
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0
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Connective tissue diseases
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Elafibranor
Treatment: Drugs - Placebo
Experimental: 120 mg Elafibranor - Coated tablets dosed at 120mg Elafibranor; oral administration; one tablet per day before breakfast with a glass of water
Placebo Comparator: Placebo - Coated placebo tablets; oral administration; one tablet per day before breakfast with a glass of water
Treatment: Drugs: Elafibranor
Treatment: Drugs: Placebo
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis
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Assessment method [1]
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To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants with fibrosis by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving NASH resolution without worsening of fibrosis. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [1]
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Measurement at 72 weeks
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Primary outcome [2]
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Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes
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Assessment method [2]
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Composite long-term outcome measured by the number of participants with the onset of any of the adjudicated events, composed of death due to any cause, histological liver cirrhosis, and the full list of portal hypertension/cirrhosis related events as follows: liver transplantation; model for end stage liver disease (MELD) score greater than or equal to 15 for participants with baseline score less than or equal to 12, and onset of variceal bleeding requiring hospitalization, hepatic encephalopathy with West Haven/Conn score greater than or equal to 2 and requiring hospitalization, spontaneous bacterial peritonitis, and ascites requiring treatment. The MELD scale ranges from 6 to 40, showing how much a participant needs a liver transplant: higher number is more urgent. The West Haven/Conn scale is 5-point (0 to 4) grading severity of hepatic encephalopathy: higher score means worse hepatic encephalopathy. This outcome measure is for the long-term endpoint analysis.
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Timepoint [2]
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From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)
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Secondary outcome [1]
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Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage
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Assessment method [1]
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To evaluate the effect of Elafibranor compared to placebo on liver histology in nonalcoholic steatohepatitis (NASH) participants by assessing the following endpoint: The number of Elafibranor-treated participants relative to placebo achieving improvement of liver fibrosis of at least 1 stage according to NASH Clinical Research Network (CRN) Scoring. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [1]
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Measurements at 72 weeks
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Secondary outcome [2]
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Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
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Assessment method [2]
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Hemoglobin A1c (HbA1c) were tested at Week 72. Changes from baseline in HbA1c at Week 72 were evaluated. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [2]
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Measurements after 72 weeks of treatment and up to study termination
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Secondary outcome [3]
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Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
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Assessment method [3]
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High-density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [3]
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Measurements after 72 weeks of treatment and up to study termination
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Secondary outcome [4]
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Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
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Assessment method [4]
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Low-density lipoprotein (LDL) cholesterol was tested at Week 72. Changes from baseline in LDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [4]
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Measurements after 72 weeks of treatment and up to study termination
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Secondary outcome [5]
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Change From Baseline of Homeostatic Model Assessment-IR (HOMA-IR) After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo in Non-diabetic Participants
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Assessment method [5]
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Homeostatic model assessment-IR (HOMA-IR) was tested at Week 72. Changes from baseline in HOMA-IR were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [5]
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Measurements after 72 weeks of treatment and up to study termination
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Secondary outcome [6]
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Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
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Assessment method [6]
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Non-high density lipoprotein (HDL) cholesterol was tested at Week 72. Changes from baseline in non-HDL cholesterol were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [6]
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Measurements after 72 weeks of treatment and up to study termination
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Secondary outcome [7]
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Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
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Assessment method [7]
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Triglycerides was tested at Week 72. Changes from baseline in triglycerides were evaluated at Week 72. As the primary efficacy objective was not met, the secondary efficacy endpoints were not formally tested. This outcome measure is for the surrogate endpoint analysis.
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Timepoint [7]
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Measurements after 72 weeks of treatment and up to study termination
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Eligibility
Key inclusion criteria
1. Males or females aged from 18 to 75 years inclusive at first screening visit.
2. Must provide signed written informed consent and agree to comply with the study
protocol.
3. Females participating in this study must be of nonchildbearing potential or using
highly efficient contraception for the full duration of the study and for 1 month
after the end of treatment, as described below:
1. Cessation of menses for at least 12 months due to ovarian failure,
2. Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically
documented ovarian failure
3. If requested by local IRB regulations and/or National laws, sexual abstinence may
be considered adequate (the reliability of sexual abstinence needs to be
evaluated in relation to the duration of the clinical trial and the preferred and
usual lifestyle of the patient)
4. Using a highly effective nonhormonal method of contraception (bilateral tubal
occlusion, vasectomized partner, or intra-uterine device)
5. Double contraception with barrier AND highly effective hormonal method of
contraception (oral, intravaginal, or transdermal combined estrogen and
progestogen hormonal contraception associated with inhibition of ovulation; oral,
injectable, or implantable progestogen-only hormonal contraception associated
with inhibition of ovulation; or intrauterine hormone-releasing system). The
hormonal contraception must be started at least 1 month prior to Randomization.
4. Histological confirmation of steatohepatitis on a diagnostic liver biopsy by central
reading of the slides (biopsy obtained within 6 months prior to randomization or
during the screening period) with at least 1 in each component of the NAS score
(steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation
scored 0-3).
5. NAS score =4.
6. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging
system.
7. Stable dose of vitamin E, polyunsaturated fatty acids, or ursodeoxycholic acid from at
least 6 months prior to diagnostic liver biopsy
8. For participants with type 2 diabetes, glycemia must be controlled. If glycemia is
controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these
requirements:
1. No qualitative change 6 months prior to diagnostic liver biopsy up to
Randomization (i.e., implementation of a new anti-diabetic therapy) for
participants treated with metformin, gliptins, sulfonylureas, sodium/glucose
cotransporter (SGLT) 2 inhibitors, glucagon-like peptide (GLP)-1 agonists, or
insulin. Dose changes of these medications are allowed in the 6 months prior to
diagnostic liver biopsy, except for GLP-1 agonists, which must remain on stable
dose in the 6 months prior to diagnostic liver biopsy.
2. No implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of
treatment (Visit 7).
Initiation of any other antidiabetic drugs is allowed after Randomization based on treating
physicians' judgment, except for glitazones which are prohibited 6 months prior to
diagnostic liver biopsy until the end of treatment.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known heart failure (Grade I to IV of New York Heart Association classification).
2. History of efficient bariatric surgery within 5 years prior to screening.
3. Uncontrolled hypertension during the Screening Period despite optimal antihypertensive
therapy
4. Type 1 diabetes participants .
5. Participants with decompensated diabetes (HbA1c>9%).
6. Participants with a history of clinically significant acute cardiac event within 6
months prior to screening
7. Weight loss of more than 5% within 6 months prior to randomization
8. Compensated and decompensated cirrhosis
9. Current or recent history (<5 years) of significant alcohol consumption
10. Pregnant or lactating females or females planning to become pregnant during the study
period.
11. Other well documented causes of chronic liver disease according to standard diagnostic
procedures
12. Participants with previous exposure to Elafibranor
13. Prohibited concomitant medication
14. Any medical conditions that may diminish life expectancy to less than 2 years
including known cancers.
15. Evidence of any other unstable or untreated clinically significant immunological,
endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric
disease.
16. Mental instability or incompetence, such that the validity of informed consent or
ability to be compliant with the study is uncertain.
17. Participants with biological criteria exclusion as per effective protocol
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2016
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/10/2020
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Sample size
Target
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Accrual to date
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Final
2157
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [2]
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Box Hill Hospital - Box Hill
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Recruitment hospital [3]
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Monash Medical Centre Clayton - Clayton
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Concord Repatriation General Hospital - Concord
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St. Vincent's Hospital Melbourne - Fitzroy
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Austin Hospital - Heidelberg
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Nepean Hospital - Kingswood
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The St George Hospital - Kogarah
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The Alfred Hospital - Melbourne
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Fiona Stanley Hospital - Murdoch
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Sir Charles Gairdner Hospital (SCGH) - Nedlands
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Westmead Hospital - Westmead
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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3128 - Box Hill
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3168 - Clayton
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Recruitment postcode(s) [4]
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2139 - Concord
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Recruitment postcode(s) [5]
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3065 - Fitzroy
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Recruitment postcode(s) [6]
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3084 - Heidelberg
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Recruitment postcode(s) [7]
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2747 - Kingswood
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Recruitment postcode(s) [8]
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2217 - Kogarah
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Recruitment postcode(s) [9]
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3004 - Melbourne
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6150 - Murdoch
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Recruitment postcode(s) [11]
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6009 - Nedlands
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Recruitment postcode(s) [12]
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2145 - Westmead
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Recruitment outside Australia
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Alabama
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La Serena
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Lyon
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Nantes
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Toulouse
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France
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Vandoeuvre Les Nancy
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France
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Villejuif
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Germany
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Northwest
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Essen
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Germany
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Frankfurt
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Germany
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Germany
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Hannover
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Heidelberg
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Germany
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Köln
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Germany
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Würzburg
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Italy
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Milano
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Italy
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Italy
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Italy
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Roma
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Italy
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Italy
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Torino
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DIF
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Porto
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Russian Federation
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Russian Federation
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Port Elizabeth
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Bern
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Lausanne
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Fatih
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Pendik
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Çapa
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Cambridge
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Portsmouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Genfit
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Ethics approval
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Summary
Brief summary
The primary objectives of this study are to evaluate the effect of Elafibranor treatment
compared to placebo on 1) histological improvement and 2) all-cause mortality and
liver-related outcomes in patients with nonalcoholic steatohepatitis (NASH) and fibrosis.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02704403
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Contacts
Principal investigator
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0
Carol Addy, MD MMSc
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Genfit
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02704403
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