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    Summary
    EudraCT Number:2019-004941-34
    Sponsor's Protocol Code Number:GFT505B-319-1
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-08-31
    Trial 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2019-004941-34
    A.3Full title of the trial
    A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Double-blind Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients with Primary Biliary Cholangitis with Inadequate Response or Intolerance to Ursodeoxycholic Acid
    A.4.1Sponsor's protocol code numberGFT505B-319-1
    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
    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
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGENFIT
    B.5.2Functional name of contact pointPascal Birman, MD
    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 +33 320 16 40 00
    B.5.6E-mailpascal.birman@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 Yes
    D.2.5.1Orphan drug designation numberEU/3/19/2182
    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 CodeSUB187548
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Primary Biliary Cholangitis
    E.1.1.1Medical condition in easily understood language
    Primary Biliary Cholangitis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10034176
    E.1.2Term PBC
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of elafibranor (80 mg/day) on cholestasis as defined by the primary endpoint over 52 weeks of the treatment compared to placebo.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of Elafibranor (80 mg/day) on normalisation of alkaline phosphatase (ALP) over 52 weeks of the treatment compared to placebo
    To evaluate the effect of Elafibranor (80 mg/day) on pruritus over 52 weeks of the treatment compared to placebo
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1)Must have provided written informed consent and agree to comply with the study protocol
    2)Males or females age of 18 to 75 years inclusive at first Screening Visit (SV)
    3)Definite or probable PBC diagnosis as demonstrated by the presence of ≥ 2 of the following 3 diagnostic criteria:
    a.History of elevated ALP levels for ≥ 6 months prior to randomization (V1)
    b.Positive anti-mitochondrial antibodies (AMA) titers (> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay [ELISA]) or positive PBC-specific antinuclear antibodies (ANA)
    c.Liver biopsy consistent with PBC
    4)Patients in whom it is safe and practical to proceed with a liver biopsy, and who agree to have:
    a.1 liver biopsy during the Screening Period (if no historical biopsy within 12 months before screening is available)
    b.1 liver biopsy after 52-weeks of treatment
    5)ALP ≥ 1.67x upper limit of normal (ULN)
    6)Total bilirubin (TB) ≤ 2x ULN
    To ensure adequate representation of moderately advanced disease or patients at risk of progression to clinical outcomes, at least 10% of randomized patients will be moderately advanced per Rotterdam Criteria (TB > ULN or Albumin < lower limit of normal [LLN]) and at least 20% will have a TB > 0.6 x ULN (patients at risk of progression)
    7)Must have at least 4 available values for PBC Worst Itch Numeric Rating Scale (NRS) during each of the 7 day intervals in the 14 days prior to randomization (V1), for a total of at least 8 values for PBC Worst Itch NRS in the last 14 days prior to randomization (V1)
    8)UDCA for at least 12 months (stable dose ≥ 3 months) prior to randomization, or unable to tolerate UDCA treatment (no UDCA for ≥ 3 months) prior to randomization (per country standard-of-care dosing)
    9)If on colchicine must be on a stable dose for ≥ 3 months prior to randomization
    10)Medications for management of pruritus (e.g., cholestyramine, rifampin, naltrexone or sertraline) must be on a stable dose for ≥ 3 months prior to randomization
    11)Patients taking statins or ezetimibe must be on a stable dose for ≥ 2 months prior to randomization
    12)Females participating in this study must be of non-child bearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the last drug intake:
    •Non-child bearing potential: cessation of menses for at least 12 months due to ovarian failure or surgical sterilization such as bilateral oophorectomy, hysterectomy, or medically documented ovarian failure for > 6 months prior to randomization
    •If required by local Institutional Review Board (IRB) / Independent Ethics Committee (IEC) and/or national regulations, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient)
    •Using a highly effective non-hormonal medical contraception (bilateral tubal occlusion, vasectomized partner or intra-uterine device) for ≥ 3 months prior to screening
    •Highly effective contraception with barrier or 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 one month prior to screening
    E.4Principal exclusion criteria
    1)History or presence of other concomitant liver disease including:
    a)Positive anti-hepatitis A virus (HAV) immunoglobulin M (IgM) antibodies or positive hepatitis B surface antigen (HBsAg) or positive anti-hepatitis C virus (HCV) ribonucleic acid (RNA) (tested for in case of known cured HCV infection or positive HCV Ab at screening)
    b)Primary sclerosing cholangitis (PSC)
    c)Alcoholic liver disease (ALD)
    d)Autoimmune hepatitis (AIH) or if treated for an overlap of PBC with AIH, or if there is suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA
    e)Nonalcoholic steatohepatitis (NASH)
    f)Gilbert’s Syndrome (exclusion due to interpretability of bilirubin levels)
    g)Known history of alpha-1 antitrypsin deficiency
    2)Clinically significant hepatic decompensation, including:
    a)History of liver transplantation, current placement on a liver transplant list, current Model for End-Stage Liver Disease-Sodium (MELD-Na) score ≥ 12 linked to hepatic impairment
    b)Patients with cirrhosis/portal hypertension complications, including known esophageal varices, ascites, history of variceal bleeds or related interventions (e.g., insertion of variceal bands or transjugular intrahepatic portosystemic shunts [TIPS]), and hepatic encephalopathy, history or presence of spontaneous bacterial peritonitis, hepatocellular carcinoma
    c)Hepatorenal syndrome (type I or II)
    3)Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget’s disease) or which may diminish life expectancy to < 2 years, including known cancers
    4)Patient has a positive test for Human Immunodeficiency Virus (HIV) Type 1 or 2 at screening, or patient is known to have tested positive for HIV
    5)Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator
    6)Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the study
    7)History of alcohol abuse, defined as consumption of more than 30 g pure alcohol per day for men, and more than 20 g pure alcohol per day for women, or other substance abuse within 1 year prior to screening visit (SV1)
    8)For female patients: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
    9)Administration of the following medications are prohibited as specified below:
    a)2 months prior to randomization and throughout the study (up to the last study visit): fibrates and glitazones
    b)3 months prior to randomization and throughout the study (up to the last study visit): Obeticholic acid (OCA), azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids; potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid isoniazid, or nitrofurantoin)
    c)12 months prior to randomization and throughout the study (up to the last study visit): antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines
    10)Patients who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or five half-lives, whichever is longer, prior to screening; patients with previous exposure to seladelpar are excluded.
    11)Patients with previous exposure to elafibranor
    12)SV value of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5x ULN
    13)SV value of albumin < 3.0 g/dL
    14)Severely advanced patients according to Rotterdam criteria (TB > ULN and albumin < LLN)
    15)SV value of international normalized ratio (INR) > 1.3 due to altered hepatic function
    16)SV value of creatine phosphokinase CPK > 2X ULN
    17)Screening serum creatinine > 1.5 mg/dL
    18)Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney failure damage or estimated glomerular filtration rate [eGFR] < 60 mL/min/1,73 m2) calculated by modification of diet in renal disease (MDRD)
    19)Platelet count < 150 X 103/µL
    20)Alfa-fetoprotein (AFP) > 20 ng/mL with 4-phase liver computed tomography (CT) or magnetic resonance imaging (MRI) suggesting presence of liver cancer
    E.5 End points
    E.5.1Primary end point(s)
    Response to treatment at week 52 defined as ALP < 1.67 x ULN and TB ≤ ULN and ALP decrease ≥ 15%.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 52
    E.5.2Secondary end point(s)
    Key Secondary Endpoint:
    Response to treatment based on ALP normalization at week 52.
    Change in pruritus from baseline through week 52 on PBC Worst Itch NRS score.

    Other Secondary Endpoints:
    1)Change from baseline in ALP at 4, 13, 26, 39 and 52 weeks
    2)ALP response defined as 10%, 20% and 40% ALP reduction from baseline at week 52
    3)Response to treatment at week 52 according to:
    a)ALP < 1.5x ULN, ALP decrease ≥ 40% and TB ≤ ULN
    b)ALP < 3x ULN, AST <2x ULN and TB ≤ 1 mg/dL (Paris I)
    c)ALP ≤ 1.5x ULN, AST ≤ 1.5x ULN and TB ≤ 1mg/dL (Paris II)
    d)TB response rate of 15% change
    e)Normalization of abnormal TB and/or albumin (Rotterdam)
    f)TB ≤ 0.6 x ULN
    g)ALP ≤ 1.67x ULN and TB ≤ 1 mg/dL [1]
    h)No worsening of TB defined as level of TB≤ ULN at week 52 or no increase from baseline of more than 0.1XULN at week 52
    4)PBC risk scores at week 52: United Kingdom (UK) PBC score [2] and GLOBE score [3]
    5)Response based on bilirubin normalization (TB ≤ ULN) at week 52
    6)Response based on albumin normalization at week 52
    7)Change from baseline to week 52 in hepatobiliary injury and liver function as measured by AST, ALT, gamma-glutamyl transferase (GGT), 5’ NT, total and conjugated bilirubin, albumin, INR and ALP fractionated (hepatic)
    8)Change from baseline to week 52 in biomarkers of inflammation as measured by high-sensitivity C-Reactive Protein (hsCRP), fibrinogen, haptoglobin and tumor necrosis factor-alpha (TNF-alfa)
    9)Change from baseline to week 52 in immune response as measured by immunoglobulin G (IgG) and IgM
    10)Change from baseline to week 52 in biomarkers, non-invasive and invasive measures of hepatic fibrosis as measured by enhanced liver fibrosis (ELF)(HA, PIINP, TIMP-1), plasminogen activator inhibitor-1 (PAI-1), transforming growth factor beta (TGF-β), cytokeratin-18 (CK-18) (M65 and M30), Pro-C3 and liver stiffness measured by Transient Elastography (TE) (continuous)
    11)Change from baseline to week 52 in lipid parameters as measured by total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), calculated VLDL-C and TG
    12)Change from baseline to week 52 in fasting plasma glucose (FPG)
    13)Change from baseline to week 52 in bile acids and biomarkers of bile acid synthesis as measured by bile acids, serum 7α-hydroxy-4-cholesten-3-one (C4) and fibroblast growth factor 19 (FGF-19)
    14)Proportion of patients with no worsening of pruritus from baseline to week 52 as measured by the PBC Worst Itch NRS
    15)Response in PBC Worst Itch NRS defined as at least 30% reduction from baseline of NRS at week 52 in patients with a baseline NRS ≥ 4
    16)Change from baseline to week 52 in 5D-Itch
    17)Change from baseline to week 52 in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 7a
    18)Change from baseline to week 52 in the Epworth Sleepiness Scale (ESS)
    19)Change from baseline to week 52 in PBC-40
    20)Change from baseline to week 52 in health utility as measured by the EQ-5D-5L
    21)Onset of clinical outcomes described as a composite endpoint composed of:
    a)Progression to histological cirrhosis for non cirrhotic patients at baseline
    b)MELD-Na > 14 for patients with baseline MELD-Na ≤12
    c)Liver transplant
    d)Uncontrolled ascites requiring treatment
    e)Hospitalization for new onset or recurrence of any of the following:
    i)variceal bleed
    ii)hepatic encephalopathy defined as West-Haven/Conn score of 2 or more
    iii)spontaneous bacterial peritonitis
    f)Death
    22)Change from baseline in the histological scores
    a)Fibrosis stage according to Nakanuma scoring
    b)Bile duct scores
    c)Cholangitis activity
    d)Interface Hepatitis activity
    e)Stage of disease (Sum of Fibrosis stage by Nakanuma and Bile duct score)
    f)Other exploratory scores (Fibrosis according to mdodifeid Ishak scoring, portal inflammation, ductular reaction, cholestasis, concentric periductal fibrosis)
    23)Safety and tolerability as assessed by
    a)Serious adverse events (SAEs), adverse events (AEs), adverse events of special interest (AESIs), physical examination, vital signs, medical history, electrocardiogram (ECG)
    b)Chemistry and hematology
    c)Liver markers
    d)Renal biomarkers (including urinalysis)
    e)Other biochemical safety markers
    f)Histology
    24)PK assessed by GFT505 and GF1007 concentrations measurement in plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    All of the secondary endpoints have defined timepoints included above.
    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 Yes
    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 No
    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 No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA55
    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
    Belgium
    Brazil
    Canada
    Chile
    Denmark
    Finland
    France
    Germany
    Italy
    Mexico
    Netherlands
    Russian Federation
    South Africa
    Spain
    Switzerland
    Turkey
    United Kingdom
    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
    LVLS
    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 months3
    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 months3
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 62
    F.4.2.2In the whole clinical trial 150
    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)
    standard of care as per investigator decision.
    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 Decision2020-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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