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    Summary
    EudraCT Number:2014-000097-19
    Sponsor's Protocol Code Number:TRANCHE
    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:2016-01-12
    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 number2014-000097-19
    A.3Full title of the trial
    Open, comparative, randomized study on the efficacy, safety and bioavailability of highly concentrated inhaled epinephrine (4 mg L-epinephrine / ml, Infectokrupp® Inhal) versus epinephrine autoinjector application (Fastjekt® Junior) in infants with acute anaphylactic reaction during a food provocation
    Offene, vergleichende, randomisierte Studie zur Wirksamkeit, Sicherheit und Bioverfügbarkeit von hochkonzentriertem inhalativen Epinephrin (4 mg L-Epinephrin/ml, Infectokrupp® Inhal) versus Epinephrin-Autoinjektor-Anwendung (Fastjekt® Junior) bei Kleinkindern mit akuter anaphylaktischer Reaktion im Rahmen einer Nahrungsmittelprovokation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Open, comparative, randomized study on the efficacy, safety and bioavailability of highly concentrated inhaled epinephrine (4 mg L-epinephrine / ml, Infectokrupp® Inhal) versus epinephrine autoinjector application (Fastjekt® Junior) in infants with acute anaphylactic reaction during a food provocation
    Offene, vergleichende, randomisierte Studie zur Wirksamkeit, Sicherheit und Bioverfügbarkeit von hochkonzentriertem inhalativen Epinephrin (4 mg L-Epinephrin/ml, Infectokrupp® Inhal) versus Epinephrin-Autoinjektor-Anwendung (Fastjekt® Junior) bei Kleinkindern mit akuter anaphylaktischer Reaktion im Rahmen einer Nahrungsmittelprovokation
    A.4.1Sponsor's protocol code numberTRANCHE
    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 SponsorCharité Universitätsmedizin Berlin
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinik für Pädiatrie m. S. Pneumologie und Immunologie
    B.5.2Functional name of contact pointProf. Dr. med. Kirsten Beyer
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.4Telephone number4930450659054
    B.5.5Fax number4930450559951
    B.5.6E-mailkirsten.beyer@charite.de
    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 Infectokrupp® Inhal
    D.2.1.1.2Name of the Marketing Authorisation holderINFECTOPHARM Arzneimittel und Consilium GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Inhalation vapour, liquid
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepinephrine
    D.3.9.1CAS number 51-43-4
    D.3.9.3Other descriptive nameL-EPINEPHRINE HYDROGEN TARTRATE
    D.3.9.4EV Substance CodeSUB72751
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number6 to 8
    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.2.1.1.1Trade name Fastjekt® Junior
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA Pharma GmbH & Co. KG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation Yes
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNepinephrine
    D.3.9.1CAS number 3198-07-0
    D.3.9.3Other descriptive nameETHYLNOREPINEPHRINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB13769MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0,15 to 0,3
    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
    Food allergy
    Nahrungsmittelallergie
    E.1.1.1Medical condition in easily understood language
    Food allergy
    Nahrungsmittelallergie
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Mean change of anaphylaxis symptom scores (ASC, considered weighted symptoms of the organ systems (CASC) and if necessary use of an additional medicinal anaphylaxis therapy, DASC) evaluated from baseline to endpoint after 20 minutes (for the FA (Full-Analysis-) population)
    Mittlere Änderung des Anaphylaxie-Symptom-Scores (ASC, berücksichtigt gewichtet die Symptome an den Organsystemen (CASC) sowie die ggf. erforderliche Anwendung einer zusätzlichen arzneilichen Anaphylaxie-Therapie, DASC) von Baseline bis zum Endpunkt nach 20 Minuten (ausgewertet für die FA-(Full-Analysis-) Population).
    E.2.2Secondary objectives of the trial
    • epinephrine plasma levels 10 minutes after the start of study medication application and changes to baseline levels determination at t1a
    • ASC and change from baseline (T1b) to all acquisition times (5, 10, 15, 20, 25, 30, 40, 50, 60 min.)
    • ASC single core values, sum of clinical score values (CASC), sum of additional anaphylaxis therapy score values (DASC) and change from baseline (T1b) to all detection times
    • Application of an additional drug therapy for the treatment of anaphylactic reactions
    • AEs, SAEs and side effects
    • Epinephrin-Plasmaspiegel 10 Minuten nach Beginn der Prüfmedikationsapplikation und Veränderung zur Baseline-Spiegelbestimmung bei t1a
    • ASC und Veränderung zur Baseline (t1b) zu allen Erfassungszeitpunkten (5, 10, 15, 20, 25, 30, 40, 50, 60 min.)
    • ASC-Einzelscorewerte, Summe der klinischen Scorewerte (CASC), Summe der zusätzlichen Anaphylaxie-Therapie-Scorewerte (DASC) und Veränderung zur Baseline (t1b) zu allen Erfassungszeitpunkten
    • Anwendung einer zusätzlichen medikamentösen Therapie zur Behandlung der anaphylaktischen Reaktion
    • UEs, SUEs und Nebenwirkungen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    (Inclusion criteria) "run-in" phase:
    • Written consent of the parents in the study participation
    • Age: 1 to 6 years of age
    • Weight 7,5 to 30kg
    • Planned inpatient admission under a medically indicated oral food challenge

    (Inclusion criteria) "Treatment" phase:
    • anaphylactic reaction during the oral food challenges, defined by:
    (1) at least two affected organ systems (skin, gastrointestinal tract, respiratory tract, and / or heart / circulatory system) with an anaphylaxis symptom score of at least 5 points or
    (2) peripheral or central airway obstruction or
    o (3) drop of blood pressure (reduced systolic blood pressure 70 mm Hg plus 2 x age in years or drop of blood pressure:> 30% drop in systolic blood pressure value)
    (Einschlusskriterien) „Run-in“-Phase:
    • Schriftliche Einwilligung der Eltern in die Studienteilnahme
    • Alter: 1 bis 6 Lebensjahre
    • Gewicht 7,5 bis 30 kg
    • Geplante stationäre Aufnahme im Rahmen einer medizinisch indizierten oralen Nahrungsmittelprovokation

    (Einschluss-kriterien) „Treatment“-Phase:
    • Therapiebedürftige anaphylaktische Reaktion im Rahmen der oralen Nahrungsmittelprovokationen, definiert durch:
    o (1.) mindestens zwei betroffene Organsysteme (Haut, Gastrointestinal-Trakt, Atemwege, und/oder Herz/Kreislauf) mit einem Anaphylaxie-Symptom-Score von mindestens 5 Punkten oder
    o (2.) periphere oder zentrale Atemwegsobstruktion oder
    o (3.) Blutdruckabfall (Reduzierter systolischer Blutdruck 70 mm Hg plus 2 x Alter in Jahren oder Blutdruckabfall: >30% Abfall des systolischen Blutdruckwertes)
    E.4Principal exclusion criteria
    - Acute feverish infection
    - Known clinically significant cardiovascular disease such as angina pectoris, obstructive cardiomyopathy, arrhythmia, diseases of the coronary arteries, the heart muscle, sclerotic vascular changes, cor-pulmonale or atherosclerosis and clinically relevant hypertension
    - known clinically relevant diabetes
    - Known hypercalcemia or hypokalemia
    - Known hyperthyroidism
    - Familiar pheochromocytoma
    - Known severe renal dysfunction or bladder dysfunction with urinary retention
    - familiar narrow-angle glaucoma
    - Known other serious diseases which not allows a participation in the clinical trial in the opinion of the investigator
    - known presence of other contraindication according to SmPC(s) of the investigational medicinal product used (Infectokrupp® Inhal, Fastjekt® Junior), in particular if a contraindicated concomitant medication is used (see below)
    - A history of hypersensitivity reactions to ingredients of the IMP used, in particular sodium metabisulphite
    - Preceding participate in this study
    - Participation in a clinical trial during the last 30 days
    - inability of the parents to understand the study instructions; obvious unreliability or lack of cooperation of the parents
    - application / taking one of the following contraindicated concomitant medications or therapies:
    - beta blockers or alpha-blockers
    - digitalis, Chinidine, halothane or cyclopropane
    - levodopa, parasympatholytics (e.g. atropine)
    - sympathomimetic, e.g. orciprenaline
    - tri- and tetracyclic antidepressants
    - Monoamine oxidase inhibitors
    - guanethidine, L-thyroxine
    - oxytocin, ornipressin, carbazochrome
    - insulin, antidiabetics
    - reserpine, mecamylamine
    - Certain antihistamines: diphenhydramine, chlorpheniramine
    - pharmaceuticals which causes potassium loss: e.g. diuretics which reduces potassium: aminophylline or theophylline
    - pharmaceutical preparations containing alcohol
    - antihistamines or leukotriene receptor antagonist during the last 72 hours
    - Long-acting beta-2-agonists, or theophylline during the past 48 hours
    - unwilling to consent to saving and propagation of pseudonymised medical data for study reasons
    - Subjects who are legally detained in an official institution
    - Subjects and their parents who are in a dependent relationship with the Investigator or the Sponsor
     Akuter fieberhafter Infekt
     Bekannte klinisch relevante Herz- und Kreislauf-Erkrankungen wie Angina pectoris, obstruktive Kardiomyopathie, Herzrhythmusstörungen, Erkrankungen der Herzkranzgefäße, des Herzmuskels, sklerotischen Gefäßveränderungen, Cor pulmonale oder Atherosklerose und klinisch relevante Hypertonie
     Bekannter klinisch relevanter Diabetes
     Bekannte Hyperkalzämie bzw. Hypokaliämie
     Bekannte Hyperthyreose
     Bekanntes Phäochromozytom
     Bekannte schwere Nierenfunktionsstörungen oder Blasenentleerungsstörungen mit Restharnbildung
     Bekanntes Engwinkelglaukom
     Bekannte sonstige schwerwiegende Erkrankungen, die einer Teilnahme nach Einschätzung des Prüfarztes entgegen stehen
     Bekanntes Vorliegen einer sonstigen Kontraindikation gemäß Fachinformation(en) der verwendeten Prüfmedikation (Infectokrupp® Inhal, Fastjekt® Junior), insbesondere Einnahme einer kontraindizierten Begleitmedikation (s.u.)
     Anamnestisch bekannte Überempfindlichkeitsreaktionen gegen Bestandteile einer der verwendeten Prüfmedikationen, insbesondere gegen Natriummetabisulfit
     Vorausgegangene Teilnahme an dieser Studie
     Teilnahme an einer klinischen Prüfung in den letzten 30 Tagen
     Unfähigkeit der Eltern, die Studienanweisungen zu verstehen; offensichtliche Unzuverlässigkeit oder fehlende Kooperationsbereitschaft der Eltern
     Anwendung/Einnahme einer der folgenden kontraindizierten Begleitmedikationen oder –therapien:
     Beta-Blocker oder Alpharezeptor-Blocker
     Digitalisglykoside, Chinidine, Halothan oder Cyclopropan
     Levodopa, Parasympatholytika (z. B. Atropin)
     Sympathomimetika, z. B. Orciprenalin
     Tri- und tetrazyklische Antidepressiva
     Monoaminooxidasehemmer
     Guanethidin, L-Thyroxin
     Oxytocin, Ornipressin, Carbazochrom
     Insulin, Antidiabetika
     Reserpin, Mecamylamin
     Bestimmte Antihistaminika: Diphenhydramin, Chlorphenamin
     Präparate, die zu Kaliumverlust führen, z. B. Kaliumentziehende Diuretika, Aminophyllin oder Theophyllin
     Alkoholhaltige Präparate
     Antihistaminika oder Leukotrienrezeptorantagonisten während der letzten 72 Stunden
     Langwirksame Beta-2-Mimetika oder Theophyllin während der letzten 48 Stunden
     Fehlende Bereitschaft zur Speicherung und Weitergabe pseudonymisierter Krankheitsdaten im Rahmen der klinischen Prüfung
     Unterbringung in einer Anstalt auf gerichtliche oder behördliche Anordnung
     Patienten und Eltern, die vom Prüfer, dem Sponsor oder der Prüfstelle abhängig sind
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint
    Mean change of anaphylaxis symptom scores (ASC, considered weighted symptoms of the organ systems (CASC) and any necessary use of an additional medicinal anaphylaxis therapy, DASC) evaluated from baseline to endpoint after 20 minutes (for the FA (Full-Analysis-) population).
    Primäre Zielparameter
    Mittlere Änderung des Anaphylaxie-Symptom-Scores (ASC, berücksichtigt gewichtet die Symptome an den Organsystemen (CASC) sowie die ggf. erforderliche Anwendung einer zusätzlichen arzneilichen Anaphylaxie-Therapie, DASC) von Baseline bis zum Endpunkt nach 20 Minuten (ausgewertet für die FA-(Full-Analysis-) Population).
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 20 minutes
    nach 20 Minuten
    E.5.2Secondary end point(s)
    • epinephrine plasma levels 10 minutes after the application of the IMP and changes to baseline levels determination in t1a
    • ASC and change from baseline (T1b) to all detection times (5, 10, 15, 20, 25, 30, 40, 50, 60 min.)
    • ASC single core values sum of clinical score values (CASC), sum of additional anaphylaxis therapy score values (DASC) and change from baseline (T1b) to all detection times
    • Application of an additional drug therapy for the treatment of anaphylactic reactions
    • AEs, SAEs and side effects
    • Epinephrin-Plasmaspiegel 10 Minuten nach Beginn der Prüfmedikationsapplikation und Veränderung zur Baseline-Spiegelbestimmung bei t1a
    • ASC und Veränderung zur Baseline (t1b) zu allen Erfassungszeitpunkten (5, 10, 15, 20, 25, 30, 40, 50, 60 min.)
    • ASC-Einzelscorewerte, Summe der klinischen Scorewerte (CASC), Summe der zusätzlichen Anaphylaxie-Therapie-Scorewerte (DASC) und Veränderung zur Baseline (t1b) zu allen Erfassungszeitpunkten
    • Anwendung einer zusätzlichen medikamentösen Therapie zur Behandlung der anaphylaktischen Reaktion
    • UEs, SUEs und Nebenwirkungen
    E.5.2.1Timepoint(s) of evaluation of this end point
    • epinephrine plasma levels 10 minutes after the application of the IMP and changes to baseline levels determination in t1a
    • ASC and change from baseline (T1b) to all detection times (5, 10, 15, 20, 25, 30, 40, 50, 60 min.)
    • ASC single core values sum of clinical score values (CASC), sum of additional anaphylaxis therapy score values (DASC) and change from baseline (T1b) to all detection times
    • Application of an additional drug therapy for the treatment of anaphylactic reactions
    • AEs, SAEs and side effects
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Fastjekt junior
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LPLV
    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 months5
    E.8.9.1In the Member State concerned days
    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: 40
    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: 5
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 35
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    children
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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)
    After completion of all planned study procedures the subjects will be regularly treated in our clinic by trained clinicians.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-05-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-06-10
    P. End of Trial
    P.End of Trial StatusOngoing
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