Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44237   clinical trials with a EudraCT protocol, of which   7338   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2015-001617-27
    Sponsor's Protocol Code Number:IVA_01_337_HSSC_15_001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-06
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2015-001617-27
    A.3Full title of the trial
    A randomized, double-blind, placebo-controlled, multicentre proof-of-concept trial of IVA337 in the treatment of diffuse cutaneous systemic sclerosis
    Een gerandomiseerd, dubbelblind, placebogecontroleerd, multicentrisch ‘proof-of-concept’ onderzoek met IVA337 bij de behandeling van diffuse cutane systemische sclerose
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to investigate the efficacy and safety of a new compound for the treatment of diffuse systemic sclerosis, called IVA337.Patients in the trial will be randomly allocated to either the new treatment or a placebo and will be unaware of which treatment they are receiving.
    Een klinisch studie om de effectiviteit en veiligheid van een nieuwe geneesmiddel, genaamd IVA337, voor de behandeling van diffuse systemische sclerose te onderzoeken. Patienten in de studie wordt willekeurig toegewezen aan ofwel de nieuwe behandeling of placebo en zijn onbewust zijn van welke behandeling ze krijgen.
    A.3.2Name or abbreviated title of the trial where available
    IVA337 SSC POC
    IVA337 SSC POC
    A.4.1Sponsor's protocol code numberIVA_01_337_HSSC_15_001
    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 SponsorInventiva SAS
    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 supportInventiva SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInventiva
    B.5.2Functional name of contact pointManager
    B.5.3 Address:
    B.5.3.1Street Address50 rue de Dijon
    B.5.3.2Town/ cityDaix
    B.5.3.3Post code21121
    B.5.3.4CountryFrance
    B.5.4Telephone number+33380447680
    B.5.5Fax number+33380447561
    B.5.6E-mailmari-carmen.delatte@inventivapharma.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 numberEMA/OD/129/14
    D.3 Description of the IMP
    D.3.1Product nameIVA337
    D.3.2Product code IVA337
    D.3.4Pharmaceutical form Capsule, hard
    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 INNIVA337
    D.3.9.1CAS number 927961-18-0
    D.3.9.2Current sponsor codeIVA337
    D.3.9.3Other descriptive name1-(6-BENZOTHIAZOLYLSULFONYL)-5-CHLORO-1H-INDOLE-2-BUTANOIC ACID
    D.3.9.4EV Substance CodeSUB176833
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 placeboCapsule, hard
    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
    Systemic sclerosis (scleroderma) (SSc) is a chronic connective tissue disorder of unknown aetiology characterized by widespread microvascular damage and excessive deposition of collagen in the skin and internal organs . Pulmonary fibrosis and pulmonary hypertension appear as the leading causes of mortality and patients with SSc have considerable morbidity from their disease due to skin fibrosis, Raynaud’s phenomenon and damage to the gastrointestinal tract, lungs, heart and kidneys.
    Systemische sclerose (scleroderma) is een chronische bindweefsel aandoening van onbekende etiologie gekenmerkt door wijdverbreide microvasculaire beschadigingen en overmatige afzetting van collageen in de huid en inwendige organen. Longfibrose en pulmonale hypertensie worden gezien als de belangrijkste doodsoorzaken en deze patiënten hebben een aanzienlijke morbiditeit van de ziekte ten gevolg van huidfibrose, het fenomeen van Raynaud en schade aan het maagdarmkanaal, longen, hart en nieren.
    E.1.1.1Medical condition in easily understood language
    Systemic sclerosis is caused by a build up of fibrous and collagen deposits in the skin and internal organs leading to damage to internal organs particularly the lung and heart.
    Systemische sclerose wordt veroorzaakt door ophoping van vezelachig collageen als afzettingen op de huid en inwendige organen wat leidt tot schade aan organen in het bijzonder de longen en het hart.
    E.1.1.2Therapeutic area Diseases [C] - Skin and Connective Tissue Diseases [C17]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10012941
    E.1.2Term Diffuse scleroderma
    E.1.2System Organ Class 100000004859
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10074034
    E.1.2Term Generalised scleroderma
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate in patients suffering from diffuse cutaneous SSc (DcSSc) the effect of 800mg and 1200mg IVA337 daily on the skin compared to placebo. The modified Rodnan Skin Score (MRSS) will be used to determine the changes in skin.
    De primaire doelstelling van dit onderzoek is het evalueren van het effect bij patiënten met diffuse cutane SSc (DSSC) 800 mg en 1200 mg IVA337 daags op de huid in vergelijking met placebo. De gemodificeerde Rodnan Skin Score (MRSS) wordt gebruikt om de veranderingen in de huid te bepalen.
    E.2.2Secondary objectives of the trial
    Secondary objectives include additional efficacy evaluations (details in the protocol), assessment of adverse events (AEs), and determination of population PK parameters of IVA337 in patients.
    Secundaire doelstellingen omvatten extra evaluaties van de effectiviteit (details in het protocol), de beoordeling van bijwerkingen (AE), en de PK parameters van IVA337 bij patiënten.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Systemic sclerosis according to ACR/EULAR 2013 criteria
    • Diffuse cutaneous SSc subset (LeRoy’s criteria)
    • Diagnosis within the past 3 years as defined by the first non-Raynaud’s symptom
    • MRSS between 10 and 25
    • Aged between 18 and 75 years
    • Informed consent documented by signature
    • Patients on stable treatment (for >3 months) with prednisone ≤ 10 mg, methotrexate≤ 20 mg/w, azathioprine ≤ 150 mg/d, mycophenolate mofetil ≤ 2g/d, or leflunomide ≤ 20 mg/d may be included in the study; the therapy must be maintained as background therapy
    MRSS tussen 10 en 25
    Leeftijd tussen 18 en 75 jaar
    Informed consent gedocumenteerd met handtekening
    Patiënten die een stabiele behandeling volgen (gedurende > 3 maanden) met prednison ≤ 10 mg, methotrexaat ≤ 20 mg/g, azathioprine ≤ 150 mg/d, mycofenolaatmofetil ≤ 2 g/d of leflunomide ≤ 20 mg/d kunnen in het onderzoek worden opgenomen; de therapie moet als achtergrondtherapie worden gehandhaafd.
    E.4Principal exclusion criteria
    •
    • Cyclophosphamide during the past 3 months
    • Requirement of IV prostanoids for critical ischemia or pulmonary hypertension in the last 3 months
    • Renal insufficiency defined by a creatinine clearance of less than 30 ml/min (CKD-EPI or MDRD formula) and/or past/current renal crisis
    • Hepatic impairment i.e. primary biliary cirrhosis and unexplained persistent liver function abnormality,
    • Gallbladder disease (Cholelithiasis is not an exclusion criterion)
    • Diabetic ketoacidosis
    • Severe cardiac (LVEF <45%) and/or pulmonary disease (FVC < 50% or pulmonary hypertension proven by right heart catheterisation)
    • History of heart failure, symptomatic coronary artery disease, significant ventricular tachyarrhythmia, stent placement, coronary artery bypass surgery, and/or myocardial infarction.
    • Recipient of solid organ transplant
    • Gastrointestinal involvement preventing oral administration of study drug
    • Chronic infections, positive serology for infection with hepatitis B or C.
    • Pregnancy, Lactation. Woman of childbearing potential unwilling to use a medically acceptable form of birth control
    • History of malignancy within the last 5 years, except for resected basal or squamous cell carcinoma of the skin, treated cervical dysplasia, or treated in situ cervical cancer
    • A recent history of alcohol or drug abuse, non-compliance with other medical therapies
    • Participation in a clinical study involving another investigational drug or device within the past 4 weeks or during the studyg
    • Laboratory parameters at the pre-treatment visit showing any of the following abnormal results: transaminases > 2x the upper limit of normal (ULN) and/or bilirubin > 2x ULN; neutrophil count < 1,500/mm3; platelet count < 100,000/mm3; haemoglobin < 9 g/dL
    • Known hypersensitivity or allergy to class of drugs or the investigational product
    • Any condition or treatment, which in the opinion of the investigator, places the subject at unacceptable risk as a patient in the trial
    • Co-therapy with biologics. Wash-out period: Any anti-TNF agent in the last 3-months: adalimumab, certolizumab, etanercept, golimumab, infliximab; abatacept in the last 3 months; rituximab in the last 6 months
    cyclofosfamide gedurende de afgelopen 3 maanden
    • Vereiste van IV prostanoïden voor pulmonale hypertensie in de laatste 3 maanden
    • Nierinsufficiëntie gedefinieerd door een creatinineklaring van minder dan 30 ml / min (CKD-EPI of MDRD formule) en / of in het verleden / huidige niercrisis
    • Leverfunctiestoornis dat wil zeggen primaire biliaire cirrose en onverklaarbare aanhoudende leverfunctie afwijking,
    • galblaas ziekte (Cholelithiasis is geen uitsluitingscriterium)
    • Diabetische ketoacidose
    • Ernstige cardiale (LVEF <45%) en / of longziekte (FVC <50% of pulmonale hypertensie bewezen met rechter hartkatheterisatie)
    • Geschiedenis van hartfalen, symptomatische coronaire hartziekte, significante ventriculaire tachycardie, stentplaatsing, coronaire bypassoperatie, en / of myocardinfarct.
    • Ontvanger van vaste orgaantransplantatie
    • Gastro-intestinale betrokkenheid welke de orale toediening van het onderzoeksgeneesmiddel belemmert.
    • Chronische infecties, positieve serologie voor infectie met hepatitis B of C
    • zwangerschap, borstvoeding. Vrouw in de vruchtbare leeftijd niet bereid om een medisch aanvaardbare vorm van anticonceptie te gebruiken (zie 7.1.3)
    • Geschiedenis van maligniteit in de afgelopen 5 jaar, met uitzondering van weggesneden basale- of plaveiselcelcarcinoom van de huid, behandelde cervicale dysplasie, of behandelde in situ baarmoederhalskanker
    • Een recente geschiedenis van alcohol- of drugsmisbruik, het niet naleven van andere medische therapieën
    • Deelname aan een klinische studie met een ander geneesmiddel of een apparaat voor onderzoek of in de afgelopen 4 weken of tijdens de studie
    • Laboratoriumparameters bij de voorbehandeling bezoek dat een van de volgende abnormale resultaten: transaminases> 2x de bovengrens van normaal (ULN) en / of bilirubine> 2 x ULN; neutrofielen <1500 / mm3; bloedplaatjes <100.000 / mm3; hemoglobine <9 g / dL.
    • Bekende overgevoeligheid of allergie voor de klasse van geneesmiddelen van het onderzoeks geneesmiddel.
    • Elke aandoening of behandeling, die naar het oordeel van de onderzoeker, de een onaanvaardbaar risico voor de patiënt in de studie tot gevolg heeft
    • Co-behandeling met biologics. Wash-out periode: Elk anti-TNF-middel in de laatste 3 maanden: adalimumab, certolizumab, etanercept, golimumab, infliximab; abatacept in de laatste 3 maanden; rituximab in de laatste 6 maanden
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome is the mean change of the Modifed Rodnan Skin Score (MRSS) from baseline to week 48
    De primaire uitkomst is de gemiddelde wijziging van de MRSS in week 48 t.o.v. uitgangsscore
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 weken
    E.5.2Secondary end point(s)
    • MRSS response rates; improvers are defined by a reduction ≥5 points and ≥25 % of MRSS
    • Overall progression of the disease: defined as absence of rescue therapy and absence of severe organ involvement (see definition below)
    • Change in pulmonary function (FVC% predicted and cDLCO% predicted)
    • Changes in patient reported outcomes (SHAQ, UCLA SCTC GIT, PROMIS29, SF36)
    • Digital ulcer net burden (defined as total number of ulcers at a certain time point minus number of ulcers at baseline) and proportion of patients who do not develop new ulcers
    • Cochin Hand Function Scale
    • Physician and patient global assessments of disease activity over the past week (VAS)
    • Change in the Combined Response Index for Systemic Sclerosis (CRISS), consisting of five variables: MRSS, FVC % predicted, physician and patient global assessments, and HAQ-DI score (from SHAQ patient reported outcome)
    • Need for escape therapy (% patients)
    • Severe organ involvement (% patients) defined by
    • New renal crisis OR
    • New or worsened clinically symptomatic and significant heart disease, considered secondary to DcSSc OR
    • Relative decline in FVC % predicted by ≥ 10% or relative decline in FVC % predicted between 5 to < 10% with associated relative decline in DLCO % predicted by ≥ 15%, provided that the decline in FVC results in FVC <75% of predicted OR
    • New or worsening of gastrointestinal disease requiring hospitalization or new requirement for parenteral nutrition OR
    • Critical digital ischemia of the extremities promoting the necrosis or gangrene OR
    • New development of pulmonary hypertension associated with pulmonary fibrosis – defined by a mean pulmonary arterial pressure of 25 mmHg or more at right heart catheterization
    •
    •
    SAFETY
    • Frequency and type of AEs
    • Lab tests: mean change and frequency of values outside the normal range
    OTHER
    • Changes in Raynaud phenomenon (Raynaud’s condition score)
    • Mean changes in activity biomarkers
    • Population pharmacokinetics
    • Follow-up: There is a follow-up visit to evaluate any changes that might occur within 12 weeks after completion of the treatment. The performed assessments listed in the Schedule of Study Procedures refer to safety and efficacy.
    • Evaluate the changes of SSc activity index
    MRSS-responspercentages; verbeteringen worden gedefinieerd als een afname van ≥ 5 punten en ≥ 25% van de MRSS
    • Algehele progressie van de ziekte: gedefinieerd als afwezigheid van reddende therapie en afwezigheid van ernstige aantasting van organen (zie definitie hieronder)
    • Wijziging in longfunctie (FVC% van de voorspelde waarde en cDLCO% van de voorspelde waarde)
    • Wijzigingen in uitkomsten gemeld door de patiënt (SHAQ, UCLA SCTC GIT, PROMIS29, SF36)
    • Nettolast van digitale ulcus (gedefinieerd als het totale aantal ulcera op een bepaald tijdpunt min het aantal ulcera bij de uitgangssituatie) en aantal patiënten die geen nieuwe ulcera ontwikkelen
    • Cochin handfunctieschaal
    • Algemene beoordelingen door de arts en de patiënt van de ziekteactiviteit gedurende de laatste week (VAS)
    • Wijziging in de Combined Response Index for Systemic Sclerosis (CRISS), bestaande uit vijf variabelen: MRSS, FVC% van de voorspelde waarde, algemene beoordelingen door de arts en de patiënt, en HAQ-DI-score (van de door de patiënt gemelde uitkomst voor SHAQ)
    • Noodzaak van een reddende therapie (% patiënten)
    • Ernstige aantasting van organen (% patiënten) gedefinieerd als
    • nieuwe niercrisis OF
    • nieuwe of verslechterde, klinisch symptomatische en significante hartaandoening, die als secundair van DcSSc wordt beschouwd OF
    • relatieve afname van FVC% van de voorspelde waarde met ≥ 10% of relatieve afname van FVC% van de voorspelde waarde tussen 5 en < 10% met geassocieerde relatieve afname van DLCO% van de voorspelde waarde met ≥ 15%, mits de afname in FVC-resultaten resulteert in FVC < 75% van de voorspelde waarde OF
    • nieuwe of verslechterende gastro-intestinale aandoening waarvoor een ziekenhuisopname vereist is of nieuwe noodzaak van parenterale voeding OF
    • kritieke ischemie van de ledematen waardoor necrose en/of gangreen wordt bevorderd OF
    • nieuwe ontwikkeling van pulmonale hypertensie geassocieerd met longfibrose, gedefinieerd als een gemiddelde pulmonale arteriële druk van 25 mmHg of meer bij rechtskatheterisatie van het hart

    VEILIGHEID
    • Frequentie en type van AE’s
    • Laboratoriumtests: gemiddelde wijziging en frequentie van waarden buiten het normale bereik

    OVERIGE
    • Wijzigingen in raynaudfenomeen (score voor de ziekte van Raynaud)
    • Gemiddelde wijzigingen in biomarkers van activiteit
    • Populatiefarmacokinetiek
    • Follow-up: Er is een follow-upbezoek ter evaluatie van eventuele wijzigingen die zich voordoen in de 12 weken na voltooiing van de behandeling. De uitgevoerde evaluaties vermeld
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study at weeks, 2, 4, 8, 12, 16, 24, 28, 32, 40, 48, 60
    gedurende de gehele studie op week 2, 4, 8, 12, 16, 24, 28, 32, 40, 48, 60
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers Study
    biomarker studie
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Switzerland
    E.8.7Trial has a data monitoring committee No
    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
    last visit of last subject
    laatste bezoek van de laatste patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 170
    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
    geen
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation EUSTAR
    G.4.3.4Network Country France
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-12
    For support, Contact us.
    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.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA