Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02704403
Registration number
NCT02704403
Ethics application status
Date submitted
16/02/2016
Date registered
10/03/2016
Titles & IDs
Public title
Phase 3 Study to Evaluate the Efficacy and Safety of Elafibranor Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)
Query!
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
Query!
Secondary ID [1]
0
0
2015-005385-38
Query!
Secondary ID [2]
0
0
GFT505-315-1
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
RESOLVE-IT
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis (NASH) With Fibrosis
0
0
Query!
Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Metabolic and Endocrine
0
0
0
0
Query!
Metabolic disorders
Query!
Diet and Nutrition
0
0
0
0
Query!
Obesity
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Connective tissue diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
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
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Number of Elafibranor-treated Participants Relative to Placebo Achieving Resolution of Nonalcoholic Steatohepatitis Without Worsening of Fibrosis
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Measurement at 72 weeks
Query!
Primary outcome [2]
0
0
Time to Long-term Outcome Composed of All-cause Mortality, Cirrhosis, and Liver-related Clinical Outcomes
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
From first randomization up to early termination of the study corresponding to 54 months (54 months being the longest duration for any given participant)
Query!
Secondary outcome [1]
0
0
Number of Elafibranor-treated Participants Relative to Placebo Achieving Improvement of Fibrosis of at Least 1 Stage
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Measurements at 72 weeks
Query!
Secondary outcome [2]
0
0
Change From Baseline of Hemoglobin A1c (HbA1c) in Diabetic Participants After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Measurements after 72 weeks of treatment and up to study termination
Query!
Secondary outcome [3]
0
0
Change From Baseline of High-density Lipoprotein (HDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
Query!
Assessment method [3]
0
0
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.
Query!
Timepoint [3]
0
0
Measurements after 72 weeks of treatment and up to study termination
Query!
Secondary outcome [4]
0
0
Change From Baseline of Low-density Lipoprotein (LDL) Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
Query!
Assessment method [4]
0
0
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.
Query!
Timepoint [4]
0
0
Measurements after 72 weeks of treatment and up to study termination
Query!
Secondary outcome [5]
0
0
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
Query!
Assessment method [5]
0
0
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.
Query!
Timepoint [5]
0
0
Measurements after 72 weeks of treatment and up to study termination
Query!
Secondary outcome [6]
0
0
Change From Baseline of Non-high Density Lipoprotein Cholesterol After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
Measurements after 72 weeks of treatment and up to study termination
Query!
Secondary outcome [7]
0
0
Change From Baseline of Triglycerides After 72 Weeks of Treatment in Elafibranor-treated Participants Relative to Placebo
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
Measurements after 72 weeks of treatment and up to study termination
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Stopped early
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/03/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
28/10/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
2157
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
Flinders Medical Centre - Bedford Park
Query!
Recruitment hospital [2]
0
0
Box Hill Hospital - Box Hill
Query!
Recruitment hospital [3]
0
0
Monash Medical Centre Clayton - Clayton
Query!
Recruitment hospital [4]
0
0
Concord Repatriation General Hospital - Concord
Query!
Recruitment hospital [5]
0
0
St. Vincent's Hospital Melbourne - Fitzroy
Query!
Recruitment hospital [6]
0
0
Austin Hospital - Heidelberg
Query!
Recruitment hospital [7]
0
0
Nepean Hospital - Kingswood
Query!
Recruitment hospital [8]
0
0
The St George Hospital - Kogarah
Query!
Recruitment hospital [9]
0
0
The Alfred Hospital - Melbourne
Query!
Recruitment hospital [10]
0
0
Fiona Stanley Hospital - Murdoch
Query!
Recruitment hospital [11]
0
0
Sir Charles Gairdner Hospital (SCGH) - Nedlands
Query!
Recruitment hospital [12]
0
0
Westmead Hospital - Westmead
Query!
Recruitment postcode(s) [1]
0
0
5042 - Bedford Park
Query!
Recruitment postcode(s) [2]
0
0
3128 - Box Hill
Query!
Recruitment postcode(s) [3]
0
0
3168 - Clayton
Query!
Recruitment postcode(s) [4]
0
0
2139 - Concord
Query!
Recruitment postcode(s) [5]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [6]
0
0
3084 - Heidelberg
Query!
Recruitment postcode(s) [7]
0
0
2747 - Kingswood
Query!
Recruitment postcode(s) [8]
0
0
2217 - Kogarah
Query!
Recruitment postcode(s) [9]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [10]
0
0
6150 - Murdoch
Query!
Recruitment postcode(s) [11]
0
0
6009 - Nedlands
Query!
Recruitment postcode(s) [12]
0
0
2145 - Westmead
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Arkansas
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
California
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Colorado
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Connecticut
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
District of Columbia
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Florida
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Georgia
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Hawaii
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Illinois
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Kentucky
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Louisiana
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Maryland
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Massachusetts
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Michigan
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Mississippi
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Missouri
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
New Jersey
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
New Mexico
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
New York
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
North Carolina
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
Ohio
Query!
Country [24]
0
0
United States of America
Query!
State/province [24]
0
0
Oklahoma
Query!
Country [25]
0
0
United States of America
Query!
State/province [25]
0
0
Pennsylvania
Query!
Country [26]
0
0
United States of America
Query!
State/province [26]
0
0
Rhode Island
Query!
Country [27]
0
0
United States of America
Query!
State/province [27]
0
0
South Carolina
Query!
Country [28]
0
0
United States of America
Query!
State/province [28]
0
0
Tennessee
Query!
Country [29]
0
0
United States of America
Query!
State/province [29]
0
0
Texas
Query!
Country [30]
0
0
United States of America
Query!
State/province [30]
0
0
Utah
Query!
Country [31]
0
0
United States of America
Query!
State/province [31]
0
0
Virginia
Query!
Country [32]
0
0
United States of America
Query!
State/province [32]
0
0
Washington
Query!
Country [33]
0
0
Argentina
Query!
State/province [33]
0
0
Buenos Aires
Query!
Country [34]
0
0
Argentina
Query!
State/province [34]
0
0
La Plata
Query!
Country [35]
0
0
Argentina
Query!
State/province [35]
0
0
Pilar
Query!
Country [36]
0
0
Argentina
Query!
State/province [36]
0
0
Ramos Mejía
Query!
Country [37]
0
0
Argentina
Query!
State/province [37]
0
0
Rosario
Query!
Country [38]
0
0
Argentina
Query!
State/province [38]
0
0
Salta
Query!
Country [39]
0
0
Belgium
Query!
State/province [39]
0
0
Bruxelles
Query!
Country [40]
0
0
Belgium
Query!
State/province [40]
0
0
Edegem
Query!
Country [41]
0
0
Belgium
Query!
State/province [41]
0
0
Gent
Query!
Country [42]
0
0
Belgium
Query!
State/province [42]
0
0
Leuven
Query!
Country [43]
0
0
Belgium
Query!
State/province [43]
0
0
Tournai
Query!
Country [44]
0
0
Canada
Query!
State/province [44]
0
0
British Columbia
Query!
Country [45]
0
0
Canada
Query!
State/province [45]
0
0
Ontario
Query!
Country [46]
0
0
Canada
Query!
State/province [46]
0
0
Quebec
Query!
Country [47]
0
0
Canada
Query!
State/province [47]
0
0
Calgary, AB
Query!
Country [48]
0
0
Canada
Query!
State/province [48]
0
0
Halifax
Query!
Country [49]
0
0
Canada
Query!
State/province [49]
0
0
Montreal
Query!
Country [50]
0
0
Canada
Query!
State/province [50]
0
0
Winnipeg, MB
Query!
Country [51]
0
0
Chile
Query!
State/province [51]
0
0
La Serena
Query!
Country [52]
0
0
Chile
Query!
State/province [52]
0
0
Los Ángeles
Query!
Country [53]
0
0
Chile
Query!
State/province [53]
0
0
Santiago
Query!
Country [54]
0
0
Chile
Query!
State/province [54]
0
0
Vina Del Mar
Query!
Country [55]
0
0
Colombia
Query!
State/province [55]
0
0
Bogota D.C
Query!
Country [56]
0
0
Colombia
Query!
State/province [56]
0
0
Bogotá
Query!
Country [57]
0
0
Colombia
Query!
State/province [57]
0
0
Cali
Query!
Country [58]
0
0
Colombia
Query!
State/province [58]
0
0
Medellin
Query!
Country [59]
0
0
Colombia
Query!
State/province [59]
0
0
Medellín
Query!
Country [60]
0
0
Czechia
Query!
State/province [60]
0
0
Brno
Query!
Country [61]
0
0
Czechia
Query!
State/province [61]
0
0
Plzen
Query!
Country [62]
0
0
Czechia
Query!
State/province [62]
0
0
Praha 2
Query!
Country [63]
0
0
Denmark
Query!
State/province [63]
0
0
Aarhus
Query!
Country [64]
0
0
Finland
Query!
State/province [64]
0
0
Helsinki
Query!
Country [65]
0
0
France
Query!
State/province [65]
0
0
Amiens
Query!
Country [66]
0
0
France
Query!
State/province [66]
0
0
Angers
Query!
Country [67]
0
0
France
Query!
State/province [67]
0
0
Clamart
Query!
Country [68]
0
0
France
Query!
State/province [68]
0
0
Clichy
Query!
Country [69]
0
0
France
Query!
State/province [69]
0
0
Créteil
Query!
Country [70]
0
0
France
Query!
State/province [70]
0
0
Limoges
Query!
Country [71]
0
0
France
Query!
State/province [71]
0
0
Lyon
Query!
Country [72]
0
0
France
Query!
State/province [72]
0
0
Marseille
Query!
Country [73]
0
0
France
Query!
State/province [73]
0
0
Montpellier
Query!
Country [74]
0
0
France
Query!
State/province [74]
0
0
Nantes
Query!
Country [75]
0
0
France
Query!
State/province [75]
0
0
Nice
Query!
Country [76]
0
0
France
Query!
State/province [76]
0
0
Paris
Query!
Country [77]
0
0
France
Query!
State/province [77]
0
0
Pessac
Query!
Country [78]
0
0
France
Query!
State/province [78]
0
0
Toulouse
Query!
Country [79]
0
0
France
Query!
State/province [79]
0
0
Vandoeuvre Les Nancy
Query!
Country [80]
0
0
France
Query!
State/province [80]
0
0
Villejuif
Query!
Country [81]
0
0
Germany
Query!
State/province [81]
0
0
Northwest
Query!
Country [82]
0
0
Germany
Query!
State/province [82]
0
0
Aachen
Query!
Country [83]
0
0
Germany
Query!
State/province [83]
0
0
Berlin
Query!
Country [84]
0
0
Germany
Query!
State/province [84]
0
0
Bonn
Query!
Country [85]
0
0
Germany
Query!
State/province [85]
0
0
Essen
Query!
Country [86]
0
0
Germany
Query!
State/province [86]
0
0
Frankfurt
Query!
Country [87]
0
0
Germany
Query!
State/province [87]
0
0
Freiburg
Query!
Country [88]
0
0
Germany
Query!
State/province [88]
0
0
Hamburg
Query!
Country [89]
0
0
Germany
Query!
State/province [89]
0
0
Hannover
Query!
Country [90]
0
0
Germany
Query!
State/province [90]
0
0
Heidelberg
Query!
Country [91]
0
0
Germany
Query!
State/province [91]
0
0
Köln
Query!
Country [92]
0
0
Germany
Query!
State/province [92]
0
0
Leipzig
Query!
Country [93]
0
0
Germany
Query!
State/province [93]
0
0
Magdeburg
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Mainz
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Würzburg
Query!
Country [96]
0
0
Italy
Query!
State/province [96]
0
0
Bologna
Query!
Country [97]
0
0
Italy
Query!
State/province [97]
0
0
Milano
Query!
Country [98]
0
0
Italy
Query!
State/province [98]
0
0
Napoli
Query!
Country [99]
0
0
Italy
Query!
State/province [99]
0
0
Palermo
Query!
Country [100]
0
0
Italy
Query!
State/province [100]
0
0
Roma
Query!
Country [101]
0
0
Italy
Query!
State/province [101]
0
0
San Giovanni Rotondo
Query!
Country [102]
0
0
Italy
Query!
State/province [102]
0
0
Torino
Query!
Country [103]
0
0
Mexico
Query!
State/province [103]
0
0
DIF
Query!
Country [104]
0
0
Mexico
Query!
State/province [104]
0
0
Acapulco
Query!
Country [105]
0
0
Mexico
Query!
State/province [105]
0
0
Guadalajara
Query!
Country [106]
0
0
Mexico
Query!
State/province [106]
0
0
Mexico City
Query!
Country [107]
0
0
Mexico
Query!
State/province [107]
0
0
Monterrey
Query!
Country [108]
0
0
Netherlands
Query!
State/province [108]
0
0
Amsterdam
Query!
Country [109]
0
0
Netherlands
Query!
State/province [109]
0
0
Maastricht
Query!
Country [110]
0
0
Netherlands
Query!
State/province [110]
0
0
Nijmegen
Query!
Country [111]
0
0
Portugal
Query!
State/province [111]
0
0
Coimbra
Query!
Country [112]
0
0
Portugal
Query!
State/province [112]
0
0
Lisboa
Query!
Country [113]
0
0
Portugal
Query!
State/province [113]
0
0
Porto
Query!
Country [114]
0
0
Portugal
Query!
State/province [114]
0
0
Vila Real
Query!
Country [115]
0
0
Puerto Rico
Query!
State/province [115]
0
0
Rio Grande
Query!
Country [116]
0
0
Puerto Rico
Query!
State/province [116]
0
0
San Juan
Query!
Country [117]
0
0
Romania
Query!
State/province [117]
0
0
Bucharest
Query!
Country [118]
0
0
Romania
Query!
State/province [118]
0
0
Timisoara
Query!
Country [119]
0
0
Russian Federation
Query!
State/province [119]
0
0
Moscow
Query!
Country [120]
0
0
Russian Federation
Query!
State/province [120]
0
0
Saint Petersburg
Query!
Country [121]
0
0
Russian Federation
Query!
State/province [121]
0
0
St. Petersburg
Query!
Country [122]
0
0
South Africa
Query!
State/province [122]
0
0
Cape Town
Query!
Country [123]
0
0
South Africa
Query!
State/province [123]
0
0
Port Elizabeth
Query!
Country [124]
0
0
Spain
Query!
State/province [124]
0
0
Barcelona
Query!
Country [125]
0
0
Spain
Query!
State/province [125]
0
0
Madrid
Query!
Country [126]
0
0
Spain
Query!
State/province [126]
0
0
Majadahonda
Query!
Country [127]
0
0
Spain
Query!
State/province [127]
0
0
Málaga
Query!
Country [128]
0
0
Spain
Query!
State/province [128]
0
0
Pontevedra
Query!
Country [129]
0
0
Spain
Query!
State/province [129]
0
0
Santander
Query!
Country [130]
0
0
Spain
Query!
State/province [130]
0
0
Sevilla
Query!
Country [131]
0
0
Sweden
Query!
State/province [131]
0
0
Stockholm
Query!
Country [132]
0
0
Switzerland
Query!
State/province [132]
0
0
Bern
Query!
Country [133]
0
0
Switzerland
Query!
State/province [133]
0
0
Lausanne
Query!
Country [134]
0
0
Switzerland
Query!
State/province [134]
0
0
Saint Gallen
Query!
Country [135]
0
0
Switzerland
Query!
State/province [135]
0
0
Zurich
Query!
Country [136]
0
0
Turkey
Query!
State/province [136]
0
0
Ankara
Query!
Country [137]
0
0
Turkey
Query!
State/province [137]
0
0
Fatih
Query!
Country [138]
0
0
Turkey
Query!
State/province [138]
0
0
Istanbul
Query!
Country [139]
0
0
Turkey
Query!
State/province [139]
0
0
Izmir
Query!
Country [140]
0
0
Turkey
Query!
State/province [140]
0
0
Pendik
Query!
Country [141]
0
0
Turkey
Query!
State/province [141]
0
0
Çapa
Query!
Country [142]
0
0
United Kingdom
Query!
State/province [142]
0
0
Birmingham
Query!
Country [143]
0
0
United Kingdom
Query!
State/province [143]
0
0
Cambridge
Query!
Country [144]
0
0
United Kingdom
Query!
State/province [144]
0
0
Frimley
Query!
Country [145]
0
0
United Kingdom
Query!
State/province [145]
0
0
Hull
Query!
Country [146]
0
0
United Kingdom
Query!
State/province [146]
0
0
London
Query!
Country [147]
0
0
United Kingdom
Query!
State/province [147]
0
0
Newcastle upon Tyne
Query!
Country [148]
0
0
United Kingdom
Query!
State/province [148]
0
0
Nottingham
Query!
Country [149]
0
0
United Kingdom
Query!
State/province [149]
0
0
Plymouth
Query!
Country [150]
0
0
United Kingdom
Query!
State/province [150]
0
0
Portsmouth
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Genfit
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT02704403
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Carol Addy, MD MMSc
Query!
Address
0
0
Genfit
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
Query!
No/undecided IPD sharing reason/comment
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
Study Protocol: Local Protocols
https://cdn.clinicaltrials.gov/large-docs/03/NCT02704403/Prot_000.pdf
Study protocol
Study Protocol: General Protocols
https://cdn.clinicaltrials.gov/large-docs/03/NCT02704403/Prot_001.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/03/NCT02704403/SAP_002.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02704403