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    Summary
    EudraCT Number:2015-005385-38
    Sponsor's Protocol Code Number:GFT505-315-1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-12
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2015-005385-38
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to investigate the safety and effectiveness of treatment with the drug Elafibranor in Patients with Non-Alcoholic Steatohepatitis (NASH) and fibrosis (a form of liver disease).
    A.4.1Sponsor's protocol code numberGFT505-315-1
    A.5.4Other Identifiers
    Name:IND numberNumber:115028
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGenfit SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGenfit SA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenfit SA
    B.5.2Functional name of contact pointPascal Birman
    B.5.3 Address:
    B.5.3.1Street AddressParc Eurasanté, 885, Avenue Eugène Avinée
    B.5.3.2Town/ cityLOOS
    B.5.3.3Post code59120
    B.5.3.4CountryFrance
    B.5.4Telephone number+33320164001
    B.5.6E-mailgft505-315-1@genfit.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameElafibranor
    D.3.2Product code GFT505
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNElafibranor
    D.3.9.1CAS number 824932-88-9
    D.3.9.2Current sponsor codeGFT505
    D.3.9.4EV Substance CodeSUB51689
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCoated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Non-Alcoholic Steatohepatitis (NASH) and fibrosis
    E.1.1.1Medical condition in easily understood language
    Non-alcoholic liver disease and fibrosis
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10016642
    E.1.2Term Fibrosis
    E.1.2System Organ Class 10018065 - General disorders and administration site conditions
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 22.0
    E.1.2Level PT
    E.1.2Classification code 10053219
    E.1.2Term Non-alcoholic steatohepatitis
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objectives - surrogate endpoint
    To evaluate the efficacy of elafibranor 120 mg QD versus placebo for 72 weeks vs placebo on resolution of NASH without worsening of fibrosis
    • Resolution of NASH is defined as the disappearance of ballooning and disappearance or persistence of minimal lobular inflammation (grade 0 or 1) with an overall pattern of injury not qualifying for steatohepatitis.
    • Worsening of fibrosis is evaluated using the NASH Clinical Research Network (CRN) fibrosis staging system and defined as progression of at least 1 stage.

    Primary objectives - long-term endpoint
    To evaluate the efficacy of elafibranor 120 mg QD versus placebo on clinical outcomes described as a composite endpoint composed of death due to any cause, histological liver cirrhosis and the full list of portal hypertension/cirrhosis related events (please refer to the protocol for a full list of events)
    E.2.2Secondary objectives of the trial
    Key secondary objective
    To assess histological changes after 72 weeks of treatment, at the time of surrogate endpoint analysis, on the following endpoint:
    • Percentage of patients with improvement of fibrosis of at least 1 stage according to NASH CRN scoring.
    To assess the clinical benefit after 72 weeks of treatment on the following metabolic endpoints:
    • Changes from baseline in triglycerides, Non-HDL cholesterol, HDL cholesterol, LDL cholesterol, HbA1c (in diabetic patients), HOMA-IR (in non-diabetic patients)

    Other secondary objectives
    • To assess histological changes after 72 weeks of treatment and at the end of the LTTP on the endpoints listed in section 2.3 of the protocol
    • To assess the endpoints listed in section 2.3 of the protocol at Week 72 and at the end of the LTTP
    • To assess the onset to events listed in section 2.3 of the protocol
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetics Sub-Study Addendum To Protocol N° GFT505-315-1, Version 2.0, dated 20November2017

    Primary objectives:
    To determine pharmacokinetic (PK) parameters of elafibranor (GFT505) and GFT1007 after 12 to 36 weeks of treatment from PK population analyses.
    E.3Principal 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:
    o Cessation of menses for at least 12 months due to ovarian failure
    o Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
    o 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)
    o Using a highly effective nonhormonal method of contraception (bilateral tubal occlusion, vasectomized partner, or intra-uterine device)
    o 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 Screening or during the Screening Period) with at least 1 in each component of the NAS (steatosis scored 0-3, ballooning degeneration scored 0-2, and lobular inflammation scored 0-3).
    5. NAS ≥4.
    6. Fibrosis stage of 1 or greater and below 4, according to the NASH CRN fibrosis staging system. For patients with fibrosis stage 1, only patients at high risk of progression will be included meaning with a NAS ≥5 and at least 2 of the following conditions: persistent elevated ALT (absence of normal value of ALT within the past year), obesity defined by a BMI ≥30, metabolic syndrome (NCEP ATP III definition), type 2 diabetes, or HOMA-IR >6.
    7. Patients in whom it is safe and practical to proceed with a liver biopsy, and who agree to have:
    o 1 liver biopsy during the Screening Period for diagnostic purpose (if no historical biopsy within 6 months before Screening is available)
    o 1 liver biopsy after 72-weeks of treatment for assessment of the treatment effects on NASH
    o a final liver biopsy after approximately 4 years of treatment (V13), unless a liver biopsy has already been performed within the past year
    o 1 liver biopsy performed only in the case of suspicion of cirrhosis (to have a histological confirmation)
    8. If a patient is treated with 1 of the following drugs: vitamin E (>400 IU/day), polyunsaturated fatty acids (>2 g/day), or ursodeoxycholic acid; a stable dose from at least 6 months prior to diagnostic liver biopsy is required.
    9. For patients with type 2 diabetes, glycemia must be controlled. If glycemia is controlled by antidiabetic drugs, change in anti-diabetic therapy must follow these requirements:
    o no qualitative change 6 months prior to diagnostic liver biopsy up to Randomization (i.e., implementation of a new anti-diabetic therapy) for patients 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.
    o no implementation of GLP-1 agonists and SGLT2 inhibitors up to 72 weeks of treatment (V7).
    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.
    E.4Principal exclusion criteria
    1. Known chronic heart failure (Grade I to IV of New York Heart Association classification).
    2. History of efficient bariatric surgery within 5 years prior to Screening, or planned bariatric surgery in the course of the study.
    3. Uncontrolled hypertension during the Screening Period despite optimal antihypertensive therapy.
    4. Type 1 diabetes patients.
    5. Patients with hemoglobin A1c [HbA1c] >9.0%. If abnormal at the first Screening Visit, the HbA1c measurement can be repeated at the latest 2 weeks prior to Randomization. A repeated abnormal HbA1c (HbA1c >9.0%) leads to exclusion.
    6. Patients receiving thiazoledinediones (glitazones [pioglitazone, rosiglitazone]) unless the drug was discontinued at least 6 months before the diagnostic liver biopsy.
    7. Patients with a history of clinically significant acute cardiac event within 6 months prior to Screening such as: stroke, transient ischemic attack, or coronary heart disease (angina pectoris, myocardial infarction, revascularization procedures).
    8. Weight loss of more than 5% within 6 months prior to Randomization.
    9. Compensated and decompensated cirrhosis (clinical and/or histological evidence of cirrhosis). Notably, NASH patients with fibrosis stage = 4 according to the NASH CRN fibrosis staging system
    are excluded.
    10. Current or recent history (<5 years) of significant alcohol consumption. For men, significant consumption is typically defined as higher than 30 g pure alcohol per day. For women, it is typically defined as higher than 20 g pure alcohol per day.
    11. Pregnant or lactating females or females planning to become pregnant during the study period.
    12. Other well documented causes of chronic liver disease according to standard diagnostic procedures including, but not restricted to:
    o positive hepatitis B surface antigen
    o positive hepatitis C Virus (HCV) RNA (tested for in case of known cured HCV infection or positive HCV Ab at Screening)
    o suspicion of drug-induced liver disease
    o alcoholic liver disease
    o autoimmune hepatitis
    o Wilson’s disease
    o primary biliary cirrhosis, primary sclerosing cholangitis
    o genetic homozygous hemochromatosis
    o known or suspected hepatocellular carcinoma (HCC)
    o history or planned liver transplant, or current MELD score >12
    13. Where applicable, patients not covered by Health Insurance System and/or not in compliance with the recommendations of National Law in force applicable to clinical trials.
    14. Patients who cannot be contacted in case of emergency.
    15. Known hypersensitivity to the investigation product or any of its formulation excipients.
    16. Patients with previous exposure to elafibranor.
    17. Patients who are currently participating in, plan to participate in, or have participated in an investigational drug trial or medical device trial containing active substance within 30 days or five half-lives, whichever is longer, prior to Screening.
    Concomitant medications:
    18. Fibrates are not permitted from 2 months before Randomization. Patients that used statins, ezetimibe, or other nonfibrate lipid lowering drugs before Screening may participate if the dosage has been kept constant for at least 2 months prior to Screening.
    19. Currently taking drugs that can induce steatosis/steatohepatitis including, but not restricted to: corticosteroids (parenteral & oral chronic administration only), amiodarone (Cordarone), tamoxifen
    (Nolvadex), and methotrexate (Rheumatrex, Trexall), which are not permitted 30 days prior to Screening and up to end of treatment.
    20. Currently taking any medication that could interfere with study medication absorption, distribution, metabolism, or excretion or could lead to induction or inhibition of microsomal enzymes, e.g.,
    indomethacin, which are not permitted from Randomization until end of treatment.
    Associated illnesses or conditions:
    21. Any medical conditions that may diminish life expectancy to less than 2 years including known cancers.
    22. Evidence of any other unstable or, untreated clinically significant immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic, or psychiatric disease
    23. Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
    In addition to the above criteria, patient should not present any of the following biological exclusion criteria:
    24. Positive anti-human immunodeficiency virus antibody.
    25. Aspartate aminotransferase (AST) and/or ALT >10 x upper limit of normal (ULN).
    26. Conjugated bilirubin > 1.50mg/dL due to altered hepatic function Note: Gilbert Disease patients are allowed into the study.
    27. International normalized ratio >1.40 due to altered hepatic function.
    28. Platelet count <100,000/mm3 due to portal hypertension.

    Please refer to the protocol for a full list of the exclusion criteria
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint:
    Surrogate endpoint - resolution of NASH - To evaluate the efficacy of elafibranor 120 mg versus placebo on the resolution of NASH without worsening of fibrosis after 72 weeks of treatment.

    Long-term endpoint – clinical outcomes (at final analysis)
    To evaluate the efficacy of elafibranor 120 mg QD versus placebo on clinical outcomes described as a composite endpoint composed of death due to any cause, histological liver cirrhosis and the full list of portal hypertension/cirrhosis related events:
    • liver transplantation
    • MELD score ≥15 for patients with a baseline MELD score ≤12
    • the onset of:
    o variceal bleed requiring hospitalization
    o hepatic encephalopathy defined as West Haven/Conn score ≥2 and requiring hospitalization
    o spontaneous bacterial peritonitis
    o ascites requiring treatment
    o hepatorenal syndrome
    o hepatopulmonary syndrome
    o chronic gastrointestinal blood loss due to portal hypertensive gastropathy (provided that these lead to hospitalization or transfusion).
    The final analysis will be performed when 456 patients experience an event listed above. This is expected to occur approximately 96 months after the first patient is randomized.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Endpoint: Surrogate endpoint - Week 72
    Primary Endpoint: Long-term endpoint - Monitored throughout the study. The final analysis will be done when 456 of these events occur. This is expected to occur approximately 96 months after the first patient is randomized
    E.5.2Secondary end point(s)
    Key secondary endpoint (at surrogate endpoint analysis)
    Percentage of patients with improvement of fibrosis of at least 1 stage according to NASH CRN scoring at 72 weeks.
    Changes from baseline to Week 72 in triglycerides, Non-HDL cholesterol, HDL cholesterol, LDL cholesterol, HbA1c (in diabetic patients), HOMA-IR (in non-diabetic patients)

    Other secondary endpoints
    • To assess histological changes after 72 weeks of treatment and at the end of the LTTP on the following endpoints:
    o percentage of patients with resolution of NASH without worsening of fibrosis (at the end of the LTTP)
    o percentage of patients with improvement of fibrosis of at least 1 stage according to NASH CRN scoring (at the end of the LTTP)
    o percentage of patients with improvement of fibrosis of at least 1 stage according to NASH CRN scoring without worsening of NASH
    o percentage of patients with no worsening of Fibrosis and no worsening of NASH
    o percentage of patients with Resolution of NASH and improvement of Fibrosis
    o percentage of patients with at least 1 point improvement in histological scores (NASH CRN scoring: total NAS, steatosis, hepatic ballooning, lobular inflammation), fibrosis (NAFLD Ishak scoring system), or portal inflammation
    o percentage of patients improvement of NAS of at least 2 points
    o percentage of patients with improvement of NAS of at least 2 points and with at least 1 point improvement in hepatic ballooning
    o percentage of patients with at least a 1 point improvement in disease activity score (sum of ballooning and lobular inflammation scores) according to NAS scoring and steatosis-activity-fibrosis (SAF) scoring
    o percentage of patients with at least a 1 point improvement in disease activity score (sum of ballooning and lobular inflammation scores) according to NAS scoring and with at least 1 point improvement in hepatic ballooning
    o percentage of patients with at least a 1 point improvement in disease activity score (sum of ballooning and lobular inflammation scores) according to steatosis-activity-fibrosis (SAF) scoring and with at least 1 point improvement in hepatic ballooning
    o percentage of patients with at least 2 points improvement in disease activity score according to NAS scoring and SAF scoring
    o changes in NAS, fibrosis (using NASH CRN and NAFLD Ishak scoring system), steatosis, hepatic ballooning, lobular inflammation, portal inflammation, SAF activity score
    o changes in area of fibrosis (normalized Collagen Proportional area in %) by morphometry
    • To assess the following endpoints at Week 72, and at the end of the LTTP:
    o changes in liver enzymes and liver markers
    o changes in noninvasive markers of fibrosis and steatosis
    o changes in lipid parameters
    o variation in body weight
    o changes in insulin resistance and glucose homeostasis markers
    o changes in inflammatory markers
    o changes in cardiovascular risk profile as assessed by Framingham scores
    o changes in liver stiffness by Fibroscan measurement
    o changes in quality of life (SF-36 questionnaire).
    • To assess the onset of:
    o histological liver cirrhosis
    o death of any cause
    o any portal hypertension or cirrhosis related events
    o cardiovascular events
    o liver-related death events.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Monitored throughout the study. The final analysis will be done when 456 of these events occur. This is expected to occur approximately 96 months after the first patient is randomized
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned13
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA82
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Belgium
    Brazil
    Canada
    Chile
    Colombia
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Italy
    Mexico
    Netherlands
    Portugal
    Romania
    Russian Federation
    South Africa
    Spain
    Sweden
    Switzerland
    Turkey
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The study will terminate upon the 456th patient (excluding exploratory F1 arm) experiencing an event (all-cause mortality, progression to histological cirrhosis, and the full list of portal hypertension/cirrhosis related events).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1557
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 667
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state130
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 820
    F.4.2.2In the whole clinical trial 2224
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-10-28
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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