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    Summary
    EudraCT Number:2018-001596-20
    Sponsor's Protocol Code Number:HelPIT-730-163-2018
    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:2018-08-02
    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 number2018-001596-20
    A.3Full title of the trial
    Influence of a Helixor® P infusion therapy on the Cancer-related Fatigue (CrF) of female patients with advanced breast cancer or female or male patients with NSCLC during oncological standard therapy - a pilot study
    Einfluss einer Helixor® P-Infusionstherapie auf die Cancer-related Fatigue (CrF) von Patientinnen mit fortgeschrittenem Mammakarzinom oder Patienten mit NSCLC unter onkologischer Standardtherapie - Pilotstudie -
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Influence of a Helixor® P infusion therapy on the Cancer-related Fatigue (CrF) of female patients with advanced breast cancer or female or male patients with lung cancer (Non small cell lung cancer) during common cancer treatment - a pilot study -
    Einfluss einer Helixor® P-Infusionstherapie auf die krebsbedingte Müdigkeit von Patientinnen mit fortgeschrittenem Brustkrebs oder Patienten/Patientinnen mit Lungenkrebs (nicht-kleinzelliges Lungenkarzinom) unter üblicher Behandlung bei Krebs - Teststudie -
    A.3.2Name or abbreviated title of the trial where available
    HelPIT-2018
    HelPIT Infusionsstudie
    A.4.1Sponsor's protocol code numberHelPIT-730-163-2018
    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 SponsorHelixor Heilmittel GmbH
    B.1.3.4CountryGermany
    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 supportHelixor Heilmittel GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelixor Heilmittel GmbH
    B.5.2Functional name of contact pointSabine Rieger
    B.5.3 Address:
    B.5.3.1Street AddressFischermühle 1
    B.5.3.2Town/ cityRosenfeld
    B.5.3.3Post code72348
    B.5.3.4CountryGermany
    B.5.4Telephone number+497428 935850
    B.5.5Fax number+497428935859
    B.5.6E-mailsrieger@helixor.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 Helixor® P 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderHelixor Heilmittel 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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNKiefernmistel-Auszug
    D.3.9.1CAS number 8001000-56-4
    D.3.9.3Other descriptive nameVISCUM ALBUM
    D.3.9.4EV Substance CodeSUB15702MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeanthroposophic medicinal product
    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 placeboSolution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    advanced breast cancer in female patients or advanced non-small cell lung cancer (NSCLC) in female or male patients during oncological standard therapy
    Brustkrebs in fortgeschrittenem Stadium bei weiblichen Patienten oder nicht-kleinzelliges Lungenkarzinom in fortgeschrittenem Stadium bei weiblichen oder männlichen Patienten unter onkogischer Standardtherapie
    E.1.1.1Medical condition in easily understood language
    advanced breast cancer in female patients or advanced lung cancer (non-small cell lung cancer (NSCLC)) in female or male patients during common cancer treatment
    Fortgeschrittener Brustkrebs bei weiblichen Patienten oder fortgeschrittener Lungenkrebs (nicht kleinzelliges Lungenkarzinom) bei weiblichen oder männlichen Patienten unter üblicher Krebsbehandlung
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    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
    Assessment of the influence of an administration of Helixor® P as an intravenous infusion on Cancer-related Fatigue (CrF, measured as total fatigue score) of patients with advanced breast cancer or advanced NSCLC during oncological standard therapy
    Prüfung des Einflusses einer Verabreichung von Helixor® P als intravenöse (i.v.) Infusion im Verlauf einer onkologischen Standardtherapie auf die Cancer-related Fatigue von Patienten mit fortgeschrittenem Mamma-Karzinom oder NSCLC erfasst als Gesamt-Fatigue-Scale
    E.2.2Secondary objectives of the trial
    Study objectives during treatment with trial medication:
    Assessment of the influence of an administration of Helixor® P as an intravenous infusion during oncological standard therapy on
    - different subscales of CrF
    - VAS-E score of CrF
    - general quality of life
    - Karnofsky Performance Index
    - functionality of mitochondria in PBMC
    - response rate of primary disease on oncological standard therapy
    in patients with advanced breast cancer or advanced NSCLC

    Evaluation of a possible connection between change in functionality of mitochondria in PBMC and change of CrF (total fatigue score and subscales of CrF)

    study objectives during follow up:
    Assessment of change of following parameters during an observation period of three months after termination of treatment with trial medication
    - total fatigue scale and subscales of CrF
    - CrF score as determined by use of VAS-E
    - general quality of life
    - Karnofsky Performance Index (KPI)
    während Studientherapie:
    Prüfung des Einflusses einer Verabreichung von Helixor® P als i.v. Infusion auf:
    - verschiedene Subskalen der CrF
    - mittels VAS-E erhobenen Scorewert der CrF
    - die allgemeine Lebensqualität (QoL)
    - den Karnofsky Performance Index (KPI)
    - die Funktionalität der Mitochondrien in PBMC
    - die Ansprechrate des Grunderkrankung auf die onkologische Standardtherapie (Tumorresponse)

    Prüfung des Einflusses einer Verabreichung von Helixor® P als i.v. Infusion auf die Verträglichkeit der Therapie mit Immun-Checkpoint-Inhibitoren durch Vergleich der Häufigkeit der Nebenwirkungen der onkologischen Standardtherapie in den entsprechenden Behandlungsgruppen

    Prüfung eines Zusammenhangs der Veränderungen der Funktionalität der Mitochondrien in PBMC und der CrF (Gesamt-Fatigue-Score und Subskalen)


    im Verlauf einer dreimonatigen Nachbeobachtung:
    Einfluss auf:
    - Gesamt-Fatigue-Scale und Subskalen der CrF
    - mittels VAS-E erhobener Scorewert der CrF
    - QoL
    - KPI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Advanced breast cancer (incurable, e.g. inoperable primary tumor, inoperable relapse and/or metastases) with planned palliative chemotherapy +/- concomitant targeted therapy(ies) or therapy with CDK4/6 Inhibitors and hormone therapy
    - advanced non-small cell lung cancer (incurable, e.g. inoperable primary tumor, inoperable relapse and/or metastases) with planned palliative combination therapy CPI + chemotherapy or with planned monotherapy with CPI or TKI
    - legal capacity
    - capacity to understand nature and scope of clinical trial and to follow the instructions of investigator
    - caucasian
    - age ≥ 18 years
    - personally signed and dated informed consent after oral and written information about risk and benefit of clinical trial
    - sex: female (breast cancer) resp. female or male (non-small cell lung cancer)
    - estimated life expectancy of at least 9 months
    - Karnofsky Performance Index ≥ 50 %
    - VAS-E score value < 61
    - sufficient bone marrow function, defined as leucocytes > 3,0 GPT/l; neutrophils ≥ 1,5 GPT/l, thrombocytes > 100 GPT/l; hemoglobin > 9 g/dl
    - sufficient kidney function (serum creatinine ≤ 1,2 x of upper limit of normal range)
    - a negative pregnancy test has to be provided for female premenopausal patients before study entry
    - written agreement of female premenopausal patients to apply an active birth-control method
    - Fortgeschrittenes Mammakarzinom (inkurabel, z. B. inoperabler Primärtumor, inoperables Rezidiv und/oder Metastasen) mit geplanter palliativer Chemotherapie +/+ begleitende zielgerichtete Therapien oder Therapie mit CDK4/6-Inhibitoren und Hormontherapiy
    - fortgeschrittenes NSCLC (inkurabel, z. B. inoperabler Primärtumor, inoperables Rezidiv und/oder Metastasen) mit geplanter palliativer Kombinationstherapie CPI + Chemotherapie oder mit geplanter Monotherapie mit CPI oder TKI
    - Geschäftsfähigkeit
    - Fähigkeit, Wesen, Tragweite und Bedeutung der klinischen Prüfung zu verstehen und den Anweisungen des Prüfers Folge zu leisten
    - Kaukasier
    - Alter ≥ 18 Jahre
    - Vorliegen einer eigenhändig unterzeichneten und datierten Einwilligungserklärung nach mündlicher und schriftlicher Aufklärung über Nutzen und Risiken der klinischen Prüfung
    - Geschlecht: weiblich (Mammakarzinom) bzw. weiblich oder männlich (NSCLC)
    - Geschätzte Lebenserwartung von mind. 9 Monaten
    - Karnofsky Performance Index ≥ 50 %
    - VAS-E Scorewert < 61
    - Ausreichende Knochenmarkfunktion, definiert als Leukozyten > 3,0 GPT/l; Neutrophile ≥ 1,5 GPT/l, Thrombozyten > 100 GPT/l; Hb > 9 g/dl
    - Ausreichende Nierenfunktion, d.h. Serumkreatinin ≤ 1,2 x der oberen Grenze des Normbereichs
    - Bei prämenopausalen Patientinnen: Schwangerschaftstest vor Einschluss in die Studie negativ
    - Vorliegen des schriftlichen Einverständnisses prämenopausaler Patientinnen, während der Studie aktive Empfängnisverhütung zu betreiben
    E.4Principal exclusion criteria
    - pregnancy
    - breast-feeding
    - manifest brain metastases with current inflammatory problems such as increased or increasing brain pressure or cerebral pressure signs, such as headaches, dizziness, visual disturbances, convulsive equivalents or other neurological symptoms
    - other cancer disease requiring Treatment (other than complaints that are clearly related to primary disease such as malignant pleural effusion or ascites
    - immunosuppressive treatment after organ transplantation
    - comorbidity with one of the following:
    • severe allergic diseases (including severe asthma bronchiale)
    • acute inflammatory or highly febrile diseases (control of CRP value)
    • persistent infection
    • severe systemic diseases as multiple sclerosis
    • hyperthyroidism with tachycardia
    • autoimmune diseases as well as chronic inflammatory bowel diseases
    • chronic granulomatous diseases e.g. tuberculosis, Crohn's disease or sarcoidosis
    • hyperhydration
    • hypokalemia, hypernatremia or hyperchloremia
    • diseases which demand a strict sodium intake (cardiac insufficiency, hypertension, generalised edemas, pulmonary edema, eclampsia, serious renal insufficiency)
    • other concomitant diseases likely to affect the significance of clinical trial
    - Urgent suspicion of allergy to mistletoe preparations via detection of anti-mistletoe lectin antibodies of the IgE type
    - planned treatment with trial medication by different route of administration (subcutanous injection or others) or with another mistletoe product
    - concurrent or planned radiotherapy within the next 3 months
    - therapy before or at the same time with thymus, Factor AF2 or other immunstimulating therapies (except therapy with immune-checkpoint-inhibitor)
    - abuse of legal or illegal drugs or severe abuse of alcohol
    - participation in a further clinical trial
    - subjects which are in a state of dependence in relation to the sponsor’s or investigator’s institutions or which are their employees.
    - Schwangerschaft
    - Stillzeit
    - Manifeste Hirnmetastasen mit aktuell bestehender entzündlicher Problematik wie erhöhter oder an-steigender Hirndruck bzw. Hirndruckzeichen, wie Kopfschmerzen, Schwindel, Sehstörungen, Krampfäquivalente oder andere neurologische Symptome
    - weitere behandlungsbedürftige Krebserkrankung (außer Beschwerden, die in einem eindeutigen Zusammenhang zur Primärerkrankung stehen wie maligner Pleuraerguss oder Aszites)
    - Immunsuppressive Therapie nach Organtransplantation
    - Vorliegen einer oder mehrerer der folgenden Begleiterkrankungen:
    • schwere allergische Erkrankungen (einschließlich schweres Asthma bronchiale)
    • akut entzündliche bzw. hoch fieberhafte Erkrankungen (Kontrolle u.a. via Messung des CRP-Werts im Serum)
    • persistierende Infektion
    • schwere systemische Erkrankungen wie multiple Sklerose
    • Hyperthyreose mit Tachykardie
    • Autoimmunerkrankungen sowie chronische entzündliche Darmerkrankungen
    • chronische granulomatöse Erkrankungen, z. B. Tuberkulose, Morbus Crohn oder Sarkoidose
    • Hyperhydratation
    • Hypokaliämie, Hypernatriämie oder Hyperchlorämie
    • Erkrankungen, die eine restriktive Natriumzufuhr gebieten (Herzinsuffizienz, Bluthochdruck, generalisierte Ödeme, Lungenödem, Eklampsie, schwere Niereninsuffizienz)
    • sonstige Begleiterkrankungen, die die Aussagekraft dieser Untersuchung beeinträchtigen könnten
    - Dringender Verdacht einer Allergie auf Mistelpräparate via Nachweis von anti-Mistellektin-Antikörpern vom Typ IgE
    - Planung einer sonstigen Begleitbehandlung mit der Prüfmedikation (subkutane oder andere Applikation) oder einem anderen Mistelpräparat
    - Aktuelle oder innerhalb der nächsten 3 Monate geplante Strahlentherapie
    - vorausgegangene oder gleichzeitige Therapie mit Thymus, Faktor AF2 oder sonstigen potentiell immunstimulierenden Therapien (außer Therapie mit Immun-Checkpoint-Inhibitoren)
    - Medikamenten- oder Drogenmissbrauch oder gefährlicher Alkoholkonsum
    - Teilnahme an einer weiteren klinischen Prüfung
    - Patienten, die zum Sponsor oder Prüfzentrum in einem Abhängigkeits- oder Angestelltenverhältnis stehen.
    E.5 End points
    E.5.1Primary end point(s)
    change of sum score of cancer-related fatigue (CrF) during three months of treatment with trial medication
    Veränderung des Summenscores der Cancer-related-Fatigue (CrF) im Verlauf einer dreimonatigen Behandlung mit dem Prüfpräparat
    E.5.1.1Timepoint(s) of evaluation of this end point
    sumscore of CrF will be determined at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial medication
    Der Summenscore der CrF wird zu Beginn sowie 2 Wochen, 5 Wochen und 3 Monate nach Behandlung mit der Prüfmedikation ermittelt
    E.5.2Secondary end point(s)
    change of the following parameters during three months of treatment with trial medication
    • subscales of CrF
    • VAS-E score
    • general quality of life
    • Karnofsky Performance Index (KPI)
    • mitochondrial function

    determination of the following parameters during three months of treatment with trial medication
    • tumor response
    • tolerability

    change of the following parameters during three months of follow up observation after end of treatment with trial medication
    • sum score of CrF
    • subscales of CrF
    • general quality of life (QoL)
    • Karnofsky Performance Index (KPI)

    determination of tumour response during three months of follow up observation after end of treatment with trial medication (if not yet assessible at the end of treatment with trial medication)

    Further explorative study objectives only:
    • assessment of the influence of an administration of Helixor® P as an intravenous infusion during an oncological standard therapy on the functionality of mitochondria in PBMC in patients with advanced breast cancer or NSCLC.
    • assessment of the relationship between the change of functionality of mitochondria in PBMC and the change of CRF (total fatigue score and subscales).
    Veränderung folgender Parameter im Verlauf einer dreimonatigen Behandlung mit dem Prüfpräparat
    • CrF (Subskalen für physische, kognitive und affektive Fatigue des CFS-D, Scorewert der VAS-E)
    • allgemeine Lebensqualität
    • Karnofsky Performance Index (KPI)
    • Mitochondrienfunktionalität

    Erfassung folgender Parameter im Verlauf einer dreimonatigen Behandlung mit dem Prüfpräparat
    • Tumorresponse
    • Verträglichkeit

    Veränderung folgender Parameter im Verlauf eines dreimonatigen Follow ups nach Abschluss der Behandlung mit dem Prüfpräparat
    • CrF (Subskalen für physische, kognitive und affektive Fatigue des CFS-D, Scorewert der VAS-E)
    • allgemeine Lebensqualität
    • Karnofsky Performance Index (KPI)
    Erfassung der Tumorresponse im Verlauf eines dreimonatigen Follow ups nach Abschluss der Behandlung mit dem Prüfpräparat (falls bei Abschluss der Behandlung mit dem Prüfpräparat noch nicht beurteilbar)

    Weitere rein explorative Studienziele:
    • Prüfung des Einflusses einer Verabreichung von Helixor® P als intravenöse Infusion im Verlauf einer onkologischen Standardtherapie auf die Funktionalität der Mitochondrien in PBMC bei Patienten mit fortgeschrittenem Mammakarzinom oder NSCLC.
    • Prüfung eines Zusammenhangs zwischen der Veränderung der Funktionalität der Mitochondrien in PBMC und der Veränderung der Cancer-related Fatigue (Gesamt-Fatigue-Score und Subskalen).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Following timepoints are planned:
    - sumscore of CrF: end of follow up only (3 months after end of treatment with trial medication)
    - subscales of CrF: at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial mediation as well as at the end of follow up
    - general QoL: at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial mediation as well as at the end of follow up
    - KPI: at the beginning, thereafter weekly until end of treatment with trial medication as well as at the end of follow up
    - mitochondrial function: at the beginning and after 2 weeks, 5 weeks and 3 months of treatment with trial medication
    - tumor response: assessment acc. to standard rules for oncological therapies
    - tolerability: continuously during collection of AE
    Folgende Endpunkte sind geplant:
    - Summenscore der CrF: Ende der Follow up-Periode (3 Monate nach Therapieende)
    - Subskalen der CrF: zu Beginn sowie 2 Wochen, 5 Wochen und 3 Monate nach Behandlung mit der Prüfmedikation sowie am Ende der Follow up-Periode
    - allgemeine Lebensqualität: zu Beginn sowie 2 Wochen, 5 Wochen und 3 Monate nach Behandlung mit der Prüfmedikation sowie am Ende der Follow up-Periode
    - KPI: zu Beginn und danach wöchentlich bis zum Ende der Behandlung mit der Prüfmedikation sowie am Ende der Follow up-Periode
    - Mitochondrienfunktionalität: zu Beginn sowie 2 Wochen, 5 Wochen und 3 Monate nach Behandlung mit der Prüfmedikation
    - Tumorresponse: Bewertung gemäß der üblichen Regeln onkologischer Therapien
    - Verträglichkeit: kontinuierlich im Rahmen der UE-Erfassung
    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 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 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 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 concerned9
    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
    Letzter Patient letztes Visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 44
    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 state144
    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 Decision2018-12-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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