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    Summary
    EudraCT Number:2013-000309-21
    Sponsor's Protocol Code Number:PREDICT
    National Competent Authority:Lithuania - SMCA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-01-28
    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 ConcernedLithuania - SMCA
    A.2EudraCT number2013-000309-21
    A.3Full title of the trial
    PREDICT trial – antibiotic prophylaxis and renal damage in congenital abnormalities of the kidney and urinary tract
    PREDICT – Antibakterinė profilaktika ir inkstų pažeidimas, esant įgimtoms inkstų ir šlapimo organų anomalijoms.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Antibiotic Prophylaxis and Renal Damage In Congenital abnormalities of
    the kidney and urinary Tract.
    Antibakterinė profilaktika ir inkstų pažeidimas esant įgimtoms inkstų ir šlapimo takų anomalijoms.
    A.3.2Name or abbreviated title of the trial where available
    PREDICT trial
    PREDICT studija
    A.4.1Sponsor's protocol code numberPREDICT
    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 SponsorAOU di Bologna, Policlinico S.Orsola-Malpighi
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistero della Salute, Project Code:RF-2010-2308451
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAOU di Bologna, Policlinico S.Orsola-Malpighi
    B.5.2Functional name of contact pointG.Montini,S.S.Neforologia Pediatric
    B.5.3 Address:
    B.5.3.1Street AddressVia Albertoni 15
    B.5.3.2Town/ cityBologna
    B.5.3.3Post code40138
    B.5.3.4CountryItaly
    B.5.4Telephone number00390516364617
    B.5.5Fax number0039051636617
    B.5.6E-mailgiovanni.montini@aosp.bo.it
    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 Yes
    D.2.1.1.1Trade name Nitrofurantoinum
    D.2.1.1.2Name of the Marketing Authorisation holderJSC Olainfarm, Latvia
    D.2.1.2Country which granted the Marketing AuthorisationLithuania
    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 nameFuradonins
    D.3.4Pharmaceutical form 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 INNNITROFURANTOIN
    D.3.9.1CAS number 67-20-9
    D.3.9.3Other descriptive nameNITROFURANTOIN
    D.3.9.4EV Substance CodeSUB09326MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    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 Yes
    D.2.1.1.1Trade name Trimetoprimum
    D.2.1.1.2Name of the Marketing Authorisation holderVitabalans Oy, Finland
    D.2.1.2Country which granted the Marketing AuthorisationLithuania
    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 nameTrimetop
    D.3.4Pharmaceutical form 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.3.9.1CAS number 738-70-5
    D.3.9.3Other descriptive nameTRIMETHOPRIM
    D.3.9.4EV Substance CodeSUB11310MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 3
    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 Yes
    D.2.1.1.1Trade name Biseptol
    D.2.1.1.2Name of the Marketing Authorisation holderMedana Pharma SA, Poland
    D.2.1.2Country which granted the Marketing AuthorisationLithuania
    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 nameBiseptol
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation Yes
    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 INNSULFAMETHOXAZOLE
    D.3.9.1CAS number 723-46-6
    D.3.9.4EV Substance CodeSUB10711MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 738-70-5
    D.3.9.3Other descriptive nameTRIMETHOPRIM
    D.3.9.4EV Substance CodeSUB11310MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The influence of congenital abnormalities of the kidney and urinary tract for developing urinary tract infections.
    Įgimtų inkstų ir šlapimo organų anomalijų – vezikoureterinio refliukso ir inkstų hipodisplazijos – įtaka šlapimo organų infekcijos išsivystymui.
    E.1.1.1Medical condition in easily understood language
    Inborn urinary tract anomaly.
    Įmita šlapimo takų anomalija.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10047371
    E.1.2Term Vesicoureteral reflux
    E.1.2System Organ Class 100000004857
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is the evaluation of the effectiveness of
    antimicrobial prophylaxis in infants with vesico-ureteral reflux grade IIIV,
    started before the first symptomatic infection.
    Įvertinti antibakterinio profilaktinio gydymo efektyvumą sumažinti šlapimo organų infekcijų skaičių, kai jis pradedamas kūdikiams, kuriems nustatytas III-V laipsnio vezikoureterinis refliuksas, iki pirmosios simptominės šlapimo organų infekcijos.
    E.2.2Secondary objectives of the trial
    The secondary objectives are the evaluation of
    1. the role of symptomatic and febrile UTIs on the appearance and
    progression of kidney damage and development of renal function;
    2. the natural history of renal function of paediatric patients with
    congenital kidney or urinary tract anomalies during the first 5 years of
    life;
    3. the natural evolution of vesico-ureteral reflux during the first 5 years
    of life and its correlation with UTIs, renal scars and impairment of renal
    function;
    4. the hypothetic role of prophylactic antibiotic therapy during the first
    months of life on BMI at 2 and 5 years of age.
    Įvertinti: simptominės ir febrilios šlapimo organų inkfekcijos reikšmę inkstų pažeidimo atsiradimui ir progresavimui ir inkstų funkcijos dinamikai; inkstų funkcijos dinamiką 5 metų laikotarpyje vaikams, kuriems yra įgimtos inkstų ir šlapimo organų anomalijos; vezikoureterinio refliukso evoliuciją 5 metų laikotarpyje ir jo ryšį su šlapimo organų infekcija, inkstų randais ir inkstų funkcijos blogėjimu; hipotetinę profilaktinės antibakterinės profilaktikos pirmais gyvenimo mėnesiais reikšmę kūno masės indeksui 2 ir 5 metų amžiaus vaikams.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Age between 1 and 4 months (20 weeks) at enrolment.
    b. Gestational age > 35 weeks.
    c. Glomerular Filtration Rate (GFR) calculated using the Schwartz formula > 15 ml/min/1.73 m2 .
    d. No previous symptomatic Urinary Tract Infections.
    e. Complete instrumental screening work-up and presence of vesicoureteral reflux grade III to V.
    f. Informed Consent form signed by the parents.
    a. 1-4 mėn. (20 savaičių) amžius įtraukimo metu.
    b. Gestacinis amžius ≥35 sav.
    c. Glomerulų filtracijos greitis (paskaičiuotas pagal Schwartz formulę) > 15 ml/min/1.73 m2.
    d. Anksčiau nebuvę simptominių ŠOI.
    e. Atlikti vaizdiniai tyrimai ir nustatytas III-V laipsnio vezikoureterinis refliuksas.
    f. Paisrašytas tėvų sutikimas.
    E.4Principal exclusion criteria
    a. Age <1 or >4 months.
    b. Gestational age < 35 weeks.
    c. Glomerular Filtration Rate (GFR) calculated using the Schwartz formula < 15 ml/min/1.73 m2 at 3 months of age.
    d. Patients with neurogenic bladder, myelomeningocele, pyeloureteral stenosis, ureterovesical junction obstruction or other malformations potentially related to the onset of micturition disorders, except ureteral valves.
    e. Patients without vesicoureteral reflux or with vesicoureteral reflux grade I or II.
    f. Hypersensitivity to all the active ingredients listed in the protocol.
    g. Children whose clinical condition is so severe that, in the Investigator’s opinion, they cannot be included in the study cohort.
    h. The use of experimental drugs during the month previous to enrolment.
    i. Children who are not able to follow the procedures indicated in the protocol or children whose parents are unable to express consent.
    a. Amžius <1 ir >4 mėn.
    b. Gestacinis amžius < 35 sav.
    c. Glomerulų filtracijos greitis (paskaičiuotas pagal Schwartz formulę) ≤ 15 ml/min/1.73 m2 trijų mėnesių amžiuje.
    d. Pacientai su neurogenine šlapimo pūsle, mielomeningocele, uretero-pelvinės jungties ir/arba uretero-veziko jungties obstrukcija ar kitomis malformacijomis, sukeliančiomis galimus šlapinimosi sutrikimus, išskyrus šlaplės vožtuvus.
    e. Pacientai, kuriems nenustatytas ar nustatytas mažo laipsnio (I ar II) VUR.
    f. Padidėjęs jautrumas visiems skiriamiems antibakteriniams preparatams.
    g. Vaikai, kurie tyrėjo nuomone dėl savo sunkios būklės yra netinkami studijai.
    h. Vartojantys eksperimentinius vaistus mėnesį iki studijos pradžios.
    i. Vaikai, kuriems negalima taikyti nustatyto protokolo ir kurių tėvai negali pasirašyti sutikimo formoje.
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the efficacy of antibiotic prophylaxis in reducing the number of urinary tract infections when initiated before the onset of the first symptomatic first symptomatic urinary tract infection in infants with vesicoureteral reflux grade III to V.
    Įvertinti antibakterinio profilaktinio gydymo efektyvumą sumažinti šlapimo organų infekcijų skaičių, kai jis pradedamas kūdikiams, kuriems nustatytas III-V laipsnio vezikoureterinis refliuksas, iki pirmosios simptominės šlapimo organų infekcijos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 months
    24 mėnesiai
    E.5.2Secondary end point(s)
    Evaluation of the role that symptomatic and febrile urinary tract infections play in the appearance and progression of renal damage and the evolution of renal function; evaluation of the natural history of renal function in paediatric patients with congenital abnormalities of the kidney and urinary tract during the first five years of life; evaluation of the natural evolution of vesicoureteral reflux during the first five years of life and its correlation with the onset of urinary tract infections, renal scars or a worsening of renal function; evaluation of the hypothetical influence of an antibiotic therapy administered during the first months of life on Body Mass Index evaluated at the 2nd and 5th year of life.
    Įvertinti: 1. simptominės ir febrilios ŠOI reikšmę inkstų pažeidimo atsiradimui ir progresavimui ir inkstų funkcijos dinamikai; 2. inkstų funkcijos vystymosi dinamiką 5 metų laikotarpyje vaikams, kuriems yra įgimtos inkstų ir šlapimo organų anomalijos; 3. VUR evoliuciją 5 metų laikotarpyje ir jo ryšį su ŠOI, inkstų randais ir inkstų funkcijos blogėjimu; 4. hipotetinę profilaktinės antibakterinės profilaktikos pirmais gyvenimo mėnesiais reikšmę KMI 2 ir 5 m. amžiaus vaikams.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months
    60 mėnesių
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sekimo grupė, negaunanti jokio profilaktinio antibakterinio gydymo
    NO drug, normal clinical surveillance
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Belgium
    Czech Republic
    France
    Germany
    Hungary
    Italy
    Lithuania
    Poland
    Portugal
    Serbia
    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
    Paskutinis paskutinio tiriamojo vizitas.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 436
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 436
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Infants, Consent should be obtained by parents/tutor
    Kūdikiai, bus gautas tėvų/globėjų sutikimas
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 300
    F.4.2.2In the whole clinical trial 436
    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)
    According to the clinical conditions will be guaranteed clinical care, and
    eventualy therapeutic, more appropriate.
    Priklausomai nuo klinikinės situacijos bus užtikrinta visa reikiama paciento priežiūra.
    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 ESCAPE group
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-02-10
    P. End of Trial
    P.End of Trial StatusOngoing
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