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    The EU Clinical Trials Register currently displays   41189   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2015-005503-84
    Sponsor's Protocol Code Number:AFNET8
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-21
    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 ConcernedGermany - BfArM
    A.2EudraCT number2015-005503-84
    A.3Full title of the trial
    A Safety Study Assessing Oral Anticoagulation with Apixaban versus Vitamin-K Antagonists in Patients with Atrial Fibrillation and End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment.
    Überprüfung der Sicherheit des oralen Anitkoagulanz Apixaban gegenüber dem Vitamin-K Antagonisten Phenprocoumon bei hämodialyseabhänigigen, chronisch nierenkranken Patienten mit Vorhofflimmern.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to demonstrate that a new antikoagulation therapy with apixaban is safe compared to another antikoagulation therapy with phenprocoumon in patients with chronic kidney disease and atrial fibrillation.
    Überprüfung der Sicherheit des neuen, oral eigenommenen Blutverdünners Apixaban gegenüber dem Blutverdünner Phenprocoumon bei chronisch nierenkranken Patienten und Vorhofflimmern.
    A.3.2Name or abbreviated title of the trial where available
    AXADIA
    AXADIA
    A.4.1Sponsor's protocol code numberAFNET8
    A.5.4Other Identifiers
    Name:BMS codeNumber:CV185-435
    Name:ClinicalTrials.govNumber:NCT02933697
    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 SponsorKompetenznetz Vorhofflimmern e.V.
    B.1.3.4CountryGermany
    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 supportBristol-Myers Squibb and Pfizer
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKompetenznetz Vorhofflimmern e.V.
    B.5.2Functional name of contact pointProjektmanagement
    B.5.3 Address:
    B.5.3.1Street AddressMendelstraße 11
    B.5.3.2Town/ cityMünster
    B.5.3.3Post code48149
    B.5.3.4CountryGermany
    B.5.4Telephone number+492519801346
    B.5.5Fax number+492519801349
    B.5.6E-mailaxadia@af-net.eu
    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 Eliquis, 2,5 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb/ Pfizer EEIG
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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.3.4Pharmaceutical form Film-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 INNAPIXABAN
    D.3.9.4EV Substance CodeSUB25425
    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 RoleComparator
    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.2.5The 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.3.4Pharmaceutical 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 INNPHENPROCOUMON
    D.3.9.1CAS number 435-97-2
    D.3.9.4EV Substance CodeSUB09781MIG
    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
    End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment and Atrial Fibrillation
    Chronische Niereninsuffizienz im Stadium 5 und Vorhofflimmern
    E.1.1.1Medical condition in easily understood language
    End-Stage Kidney Disease (ESKD) on Chronic Hemodialysis Treatment and Atrial Fibrillation
    Chronische Niereninsuffizienz im Stadium 5 und Vorhofflimmern
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10003658
    E.1.2Term Atrial fibrillation
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10076412
    E.1.2Term Chronic kidney disease stage 5
    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 of the study is to assess the safety of the factor Xa inhibitor apixaban versus a vitamin-K antagonist phenprocoumon in patients with AF and ESKD on hemodialysis.

    The safety will be assessed by means of the incidence of major and clinically relevant, non-major bleeding as well as specific bleedings in dialysis patients
    Primäres Ziel der AXADIA Studie ist, es zu untersuchen, ob der Faktor Xa Inihibitor Apixaban im Vergleich zu dem Vitamin-K Antagonisten Phenprocoumon sicher ist bei chronisch nierenkranken Patienten mit Vorhofflimmern. Die Sicherheit wird anhand der Existenz von major und klinisch relevanten non-major Blutungen untersucht.
    E.2.2Secondary objectives of the trial
    The secondary objective of the study is to compare the efficacy of the factor Xa inhibitor apixaban with the VKA phenprocoumon regarding prevention of thromboembolic events in patients with ESKD on hemodialysis and AF.
    Das sekundäre Ziel der AXADIA Studie ist es, zu vergleichen, ob der Faktor Xa Inhibitor Apixaban gegenüber dem Vitamnin-K Antagonisten Phenprocoumon bei chronisch nierenkranken Patienten im Hämodiayseprogramm und Vorhofflimmern wirksam ist. Die Wirksamkeit wird anhand der Existenz von thromboembolischen Ereignissen ausgewertet.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    A substudy will be performed with 16 patients of the main study which will reveive apixaban. The substudy analyzes the plasma levels of apixaban prior and after hemodialysis.
    Eine Substudie im Rahmen der Hauptstudie untersucht die Plasmakonzentration von Apixaban bei 16 Patienten vor und nach Hämodialyse.
    E.3Principal inclusion criteria
    End-stage kidney disease (ESKD) with chronic hemodialysis treatment 3 times per week (with at least 3,5 hours per dialysis)
    Chronic (i.e. repeated) paroxysmal, persistent or permanent atrial fibrillation (AF) or atrial flutter (AFL) documented by standard or Holter ECG on at least 2 separate days before (or apart from) hemodialysis procedures
    Increased risk of stroke or systemic embolism identified by a CHA2DS2-VASc score of 2 or more as an indication for oral anticoagulation
    Patients with ischemic stroke that meet the above criteria, can be included after more than 3 months if not severely handicapped (modified Rankin scale 0 or 1 of 6, i.e. no symptoms or no significant disability and able to carry out all usual activities, despite some symptoms (Farrell, Godwin, Richards, and Warlow (1991))
    Males and females, aged 18 or older
    Chronische Niereninsuffizienz, Stadium 5 mit chronischer Hämodialyse, dreimal pro Woche, über einen Zeitraum von mindestens 3,5 Stunden
    Chronisches, paroxysmales, persistierendes oder permanentes Vorhofflimmern (AF) oder Vorhofflattern (AFL), dokumentiert in zwei unabhängigen Standard EKG Aufzeichnungen oder in zwei Holter EKG Messungen vor oder außerhalb der Hämodialyse
    Erhöhtes Risiko für Schlaganfall oder systemische Embolien festgelegt durch einen CHA2DS2-VASc Score von 2 oder höher.
    Patienten mit voran gegangenem ischämischen Schlaganfall können eingeschlossen werden, insofern der Schlaganfall mehr als 3 Monate vor Studienbeginn zurückliegt und der Patient keine schwerwiegenden Beeinträchtigungen [modifizierter Rankin Scale 0 oder 1 von 6, wie z.B. die Ausführung aller alltäglichen Aktivitäten, trotz einiger Symptome (Farrell, Godwin, Richards, and Warlow (1991)] davon getragen hat
    Männer und Frauen, älter als 18 Jahre
    E.4Principal exclusion criteria
    AF or AFL due to reversible causes (e.g., thyrotoxicosis, pericarditis)
    Patients with a new onset of hemodialysis within the last 3 months
    Clinically significant (moderate or severe) aortic and mitral stenosis
    Conditions other than AF that require chronic anticoagulation (e.g., a prosthetic mechanical heart valve).
    Active infective endocarditis
    Any planned interventional or surgical AF or AFL ablation procedure
    Any active bleeding
    A serious bleeding event in the previous 6 months before screening
    Inadequately controlled (HbA1c levels >8.5%) or untreated diabetes
    History of malignant neoplasms at high risk of current bleeding (see summary of product characteristics (SmPC) of study drugs)
    Known indication for treatment with NSAIDs (see SmPC of study drugs) - acetylsalicylic acid (ASA) up to 100 mg per day is allowed
    Impaired liver function e.g., caused by active infection with HIV, HBV or HCV, hepatitis or other liver damage (No limits for ALT and AST values are defined in this study protocol, although mentioned in the SmPC because they are frequently elevated in dialysis patients. In case of clinically relevant increase of ALT or AST level, patient’s eligibility is to be decided by the responsible investigator)
    Any type of stroke within 3 months prior to baseline
    Other indication for anticoagulation than AF or AFL
    Exisiting Antiphospholipid Syndrome
    Valvular heart disease requiring surgery
    A high risk of bleeding (e.g., active peptic ulcer disease, a platelet count of <100,000 per cubic millimeter or hemoglobin level of <8 g per deciliter)
    Documented hemorrhagic tendencies or blood dyscrasias
    Current alcohol or drug abuse
    Life expectancy of less than 1 year
    Indication for dual platelet inhibition at baseline (ASA ≤ 100 mg/day is allowed, clopidrogel is excluded at any dose).
    Reversibles AF oder AFL (z.B. durch Perikarditis oder Thyrotoxsis)
    Patienten, die sich erstmals in den letzten 3 Monaten einer Hämodialyse unterzogen haben
    Alle Arten von Schlaganfall, die weniger als 3 Monate vor Studieneinschluss aufgetreten sind
    Aktive Blutungen
    Schwerwiegendes Blutungsereignis innerhalb der letzten 6 Monate vor Studienbeginn
    Hohes Risiko für eine Blutung (z.B. durch ein aktives gastrointestinales Geschwür, Thrombozytenzahl unter 100,000/cm³, oder Hämoglobinwerte unter 8 g/ dl)
    Zustand nach malignen Tumorerkrankungen, die ein hohes Risiko für Blutungen haben (wie in der Fachinformation für Antikoagulanzien beschrieben)
    Dokumentierte hämorrhagische Neigung oder Dyskrasie
    Herzklappenerkrankung, die operativ behandelt werden muss
    Klinisch signifikante Aorten- oder Mitralklappenstenose (moderat bis schwerwiegend)
    Aktive, infektiöse Endokarditis
    Indikation für eine Ablation aufgrund von Vorhofflimmern oder Vorhofflattern
    Antikoagulation, die nicht mit Vorhofflimmern einhergeht, wie z.B. Kunstklappenprothese
    Bestehendes Antiphospholipidsyndrom
    Dokumentierte Unverträglichkeit gegenüber einem oder beiden Wirkstoffen der Prüfmedikation
    Indikation für die Behandlung mit Clopidogrel in jeglicher Dosierung
    Indikation für eine duale Plättcheninhibition an der Baselinevisite (ASA ≤ 100 mg/ Tag ist zulässig).
    Unkontrollierter oder unbehandelter Diabetes mellitus
    (HbA1c >8.5%)
    Bekannte Indikation für die Behandlung mit nicht-steriodalen antiinflammatorischen Medikamenten (cave: , Acetylsalicylsäure in Dosierungen unter 100 mg/ Tag ist erlaubt)
    Eingeschränkte Leberfunktion, verursacht durch eine aktive Infektion mit HIV, HBV oder HCV, Hepatitis oder anderen Leberschädigungen (der Einschluss von Patienten mit klinisch signifikant erhöhten ALT oder AST Werten können nach dem Ermessen des Prüfarztes eingeschlossen werden)
    Aktuelle Alkohol- oder Drogenabhängigkeit
    Lebenserwartung geringer als 1 Jahr
    E.5 End points
    E.5.1Primary end point(s)
    First occurence of Major Bleeding (as defined in the International Society on Thrombosis and Haemostasis (ISTH) consensus):
    • Fatal bleeding
    • Bleeding that is symptomatic and occurs in a critical area or organ, such as intracranial, intraspinal, intraocular retroperitoneal, pericardial, in a non-operated joint, or intramuscular with compartment syndrome
    • Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more
    • Bleeding leading to transfusion of two or more units of whole blood or red cells, with temporal association within 24–48 h to the bleeding
    • Bleeding that requires an operation or endoscopic intervention (arthroscopic, endovascular or a hemarthrosis)
    • All-cause death
    Clinically relevant, non-major bleeding (according to ISTH consensus, complemented by relevant bleeding events in dialysis patients):
    • Bleeding resulting in hospitalization or prolonged hospitalization
    • Bleeding requiring medical or surgical treatment by a physician
    • Bleeding leading to a modification of the given anticoagulant therapy
    • Gastrointestinal bleeding proven by endoscopy or surgery
    • Shunt- / catheter-induced bleeding
    • Bleeding between dialysis sessions
    • Prolonged bleeding requiring compression for more than 30 min after dialysis needle removal
    Erstes Auftreten von Major Blutungen [definiert nach den Richtlinien der International Society on Thrombosis and Haemostasis (ISTH)]:
    • Fatale Blutungen
    • Symptomatische Blutungen und Blutungen, die in einer kritischen Region oder Organ auftreten, wie z.B. intrakranielle, intraspinale, intraokkuläre, retroperitoneale, perikardiale in einer nicht-operativen Region oder intramuskluäre Blutungen mit Komparmentsyndrom
    • Blutungen, die zu einem Hämoglobinabfall von 20 g/L (1.24 mmol/L) und größer führen
    • Blutungen, die zu einer Transfusion von zwei oder mehr Einheiten von weißen oder roten Blutkörperchen innerhalb der letzten 24-48 Stunden nach Blutungseintritt führen
    • Blutungen, die eine Operation oder eine endoskopischen Eingriff verursachen
    • Alle Arten von Todesfällen

    Non-major Blutungen (nach den ISTH Richtlinien, ergänzt durch beschriebene Blutungsereignisse bei Dialysepatienten):
    • Blutungen, die zu einer Hospitalisierung oder Verlängerung der Hospitalisierung führen
    • Blutungen, die zu einem Arztbesuch oder einem operativen Eingriff führen
    • Blutungen, die zu einer Änderung der bestehenden Antikoagulation führen
    • Endoskopische oder operativ nachgewiesene gastrointestinale Blutungen
    • Shunt- oder katheterbasierte Blutungen
    • Blutungen zwischen zwei Dialysebesuchen
    • Verlängerte Nachblutungszeit, die eine Kompression benötigt und länger als 30 min. nach dem Entfernen der Injektionsnadel anhält
    E.5.1.1Timepoint(s) of evaluation of this end point
    In the primary statistical analysis the treatments will be compared with respect to the primary safety endpoint time to first occurrence of a major or clinically relevant non-major bleeding or death of any cause
    Zeitpunkt bis zum ersten Auftreten eines primären Endpunktes nach mindestens einer Studienmedikationsgabe.
    E.5.2Secondary end point(s)
    Efficacy events
    • Myocardial infarction
    • Ischemic stroke
    • All-cause death
    • Cardiovascular death
    • Deep vein thrombosis and/or pulmonary embolism
    • Quality-of-life status

    Events of special interest
    • Dialysis shunt thrombosis
    • Clotting of dialysis Membrane

    Composite endpoint:
    • Myocardial infarction
    • Ischemic stroke
    • All-cause death
    • Deep vein thrombosis and/or pulmonary embolism
    Ereignisse zum Wirksamkeitsnachweis:
    • Myokardinfarkt
    • Ischämischer Schlaganfall
    • Tod
    • Kardiovaskulärer Tod
    • Tiefe Venenthrombose und/ oder Lungenembolie

    Ereignisse von speziellem Interesse:
    • Shunt Thrombose während der Dialyse
    • Koagulation der Dialysemembran

    Zusammengesetzte Endpunkte:
    • Myokardinfarkt
    • Ischämischer Schlaganfall
    • Tod
    • Tiefe Venenthrombose und/ oder Lungenembolie
    E.5.2.1Timepoint(s) of evaluation of this end point
    The secondary endpoints, both events of special interest and the composite endpoint are the efficacy endpoints and will be analyzed on an intention-to-treat-basis by descriptive statistics.
    Zeitpunkt bis zum ersten Auftreten eines sekundären Endpunktes nach mindestens einer Studienmedikationsgabe.
    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 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 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) Yes
    E.8.2.2Placebo No
    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 concerned35
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Letzte Visite, letzter Patient
    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 months1
    E.8.9.1In the Member State concerned 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: 14
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 65
    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 state79
    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.
    Keine.
    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 Decision2018-02-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-22
    P. End of Trial
    P.End of Trial StatusOngoing
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