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    Summary
    EudraCT Number:2017-003221-15
    Sponsor's Protocol Code Number:Uni-Koeln-3128
    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:2018-10-11
    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 number2017-003221-15
    A.3Full title of the trial
    PROSPEKTIV RANDOMISIERTE, MULTIZENTRISCHE STUDIE ZUM
    VERGLEICH DER EINER RADIKALEN HYSTEREKTOMIE NACH
    NEOADJUVANTER CHEMOTHERAPIE VERSUS EINER PRIMÄREN
    RADIOCHEMOTHERAPIE BEI PATIENTINNEN MIT EINEM
    ZERVIXKARZINOM
    DER FIGO- STADIEN IB2 UND IIB
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PROSPEKTIV RANDOMISIERTE, MULTIZENTRISCHE STUDIE ZUM
    VERGLEICH DER EINER RADIKALEN HYSTEREKTOMIE NACH
    NEOADJUVANTER CHEMOTHERAPIE VERSUS EINER PRIMÄREN
    RADIOCHEMOTHERAPIE BEI PATIENTINNEN MIT EINEM
    ZERVIXKARZINOM
    DER FIGO- STADIEN IB2 UND IIB
    A.3.2Name or abbreviated title of the trial where available
    NACOPRAD-Studie
    A.4.1Sponsor's protocol code numberUni-Koeln-3128
    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 SponsorUniversität zu Köln
    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 supportDeutsche Krebshilfe
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationZKS Tübingen
    B.5.2Functional name of contact pointProjektmanagement, Dr. Walker
    B.5.3 Address:
    B.5.3.1Street AddressFrondsbergstrasse 23
    B.5.3.2Town/ cityTübingen
    B.5.3.3Post code72070
    B.5.3.4CountryGermany
    B.5.4Telephone number+49707185635
    B.5.5Fax number+49707125080
    B.5.6E-mailzks-pm@med.uni-tuebingen.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.2.1.2Country 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.3.1Product nameCARBOPLATIN
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCarboplatin
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number400
    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.2.1.2Country 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.3.1Product namePaclitaxel
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number80 to 175
    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.2.1.2Country 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.3.1Product nameCisplatin
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCISPLATIN
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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: 4
    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.2.1.2Country 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.3.1Product nameIfosfamid
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIFOSFAMIDE
    D.3.9.1CAS number 3778-73-2
    D.3.9.4EV Substance CodeSUB08125MIG
    D.3.10 Strength
    D.3.10.1Concentration unit gm/m2 gram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 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
    Patientinnen mit einem histologisch gesicherten Plattenepithel-,
    Adeno- oder adenosquamösen Zervixkarzinom FIGO Stadium
    IB2 oder IIB
    E.1.1.1Medical condition in easily understood language
    Patientinnen mit einem histologisch gesicherten Plattenepithel-,
    Adeno- oder adenosquamösen Zervixkarzinom FIGO Stadium
    IB2 oder IIB
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008242
    E.1.2Term Cervical carcinoma stage IB
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10008245
    E.1.2Term Cervical carcinoma stage IIB
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Überlegenheit bzgl. Wirksamkeit (Disease Free Survival, DFS)
    der Therapie eines der beiden Arme:
    Radikale Hysterektomie nach NACT mit Carboplatin, Paclitaxel
    (TP) bzw. Cisplatin, Paclitaxel, Ifosfamid (TIP) versus primäre
    Radiochemotherapie mit Cisplatin bei Patientinnen mit einem
    Zervixkarzinom der FIGO Stadien IB2 und IIB.
    Stratifiziert wird nach Zentren und FIGO-Stadium. Jedes
    Zentrum muss sich entweder für TP oder TIP entscheiden.
    E.2.2Secondary objectives of the trial
    Overall Survival (OS), Lebensqualität, Sexualität, Toxizität,
    Morbidität.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Patientin über 18 Jahre.
    • Karnofsky-Index ≥70.
    • durch Biopsie gesichertes Plattenepithel-, Adeno- oder
    adenosquamöses Zervixkarzinom in den FIGO Stadien
    IB2 oder IIB (Tumorausbreitung parametran ohne
    Harnstauung).
    • Unterschriebene Einverständniserklärung.
    • Keine vorangegangene maligne Erkrankung (außer
    Basaliom der Haut).
    • Keine vorherige Strahlentherapie.
    • Keine vorherige Chemotherapie.
    • Normale Nierenfunktion (Kreatinin-Clearance ≥60 ml/h) nach MDRD-Formel
    • Narkosefähigkeit aus anästhesiologischer Sicht.
    • Negativer Schwangerschaftstest maximal 7 Tage vor Therapiebeginn.
    • Simultane Verwendung zweier zuverlässigen Verhütungsformen (z.B. orale Verhütung und Verwendung eines Kondoms) oder das Einhalten kompletter Abstinenz von heterosexuellem Kontakt während der gesamten Studienteilnahme (eingeschlossen Therapieunterbrechungen) und für den Zeitraum von 6 Monaten nach letzter Therapieintervention
    • Verzicht auf das Stillen während der Studienteilnahme und einem Zeitraum 6 Monaten nach letzter Therapieintervention
    • Monatliche Schwangerschaftstests
    • Negative Hepatitis Serologie (HepB, HepC)
    • Negativer HIV-Test
    E.4Principal exclusion criteria
    • Fernmetastasierung (Ausnahme: histologisch
    gesicherte paraaortale Lymphknotenmetastasen);
    • Neuroendokrine Tumoren bzw. Mischtypen mit
    neuroendokrinen Anteilen;
    • Vormalige oder bestehende Zweitneoplasie; Ausnahme
    Basaliom der Haut.
    • Niereninsuffizienz (Kreatininclearance<60 ml/min) nach MDRD-Formel
    • Psychiatrische oder neurologische Erkrankungen, die
    eine Kooperationsfähigkeit nicht möglich machen;
    • HIV-Infektion bzw. Aidserkrankung in der
    Vorgeschichte, Drogenabhängigkeit bekannt;
    • fehlende Bereitschaft zur Speicherung und Weitergabe
    persönlicher Krankheitsdaten im Rahmen des
    Protokolls, mangelnde Compliance- und fehlende
    Bereitschaft zur Studie und regelmäßiger Nachsorge;
    • Frühere Strahlentherapie des Beckens;
    • Frühere Chemotherapie;
    • Bestehende Schwangerschaft, Stillzeit, Frauen ohne
    zuverlässige Kontrazeption während der
    Radiochemotherapie;
    • Schwere internistische Begleiterkrankung
    (Myokardinfarkt, Kardiomyopathie, Herzinsuffizienz
    NYHA III/IV, schwere COPD, nicht einstellbarer
    Diabetes mellitus, unkontrollierte Infektionen).

    • Kontraindikationen Carboplatin:
    - bei Überempfindlichkeit gegen den Wirkstoff selbst, andere platinhaltige Verbindungen
    -bei Patienten mit schwerer vorbestehen- der Nierenfunktionsstörung (Kreatinin- clearance <30 ml/min)
    -bei Patienten mit einer schweren Knochenmarkschädigung
    -bei Patienten mit blutenden Tumoren
    -in der Stillzeit

    • Kontarindikationen Paclitaxel:
    -Überempfindlichkeit gegen den Wirkstoff, Macrogolglycerolricinoleat (Ph.Eur.) oder einen der sonstigen Bestandteile (Macrogolglycerolricinoleat(Ph.Eur., Ethanol).
    -Paclitaxel sollte bei Patienten mit Neutro-philen-Ausgangswerten von < 1.500/mm3 (< 1.000/mm3 bei AIDS-Patienten) nicht angewendet werden.
    -Paclitaxel ist auch kontraindiziert bei AIDS-Patienten mit bestehenden, schwerwiegenden und nicht behandelten Infektionen.
    -Paclitaxel ist kontraindiziert während der Stillzeit.

    • Kontraindikationen Cisplatin:
    -Überempfindlichkeit gegen den Wirkstoff oder weitere Bestandteile (Wasser für Injektionszwecke, Natriumchlorid
, Salzsäure 1 N zur pH-Einstellung, Natriumhydroxid 1 N zur pH-Einstellung) oder andere platinhaltige Arzneimittel.
    -bei Patienten mit einer Myelosuppression, cisplatinbedingter Neuropathie,
    -dehydrierten Patienten (zur Vorbeugung einer schwerwiegenden Nierenfunktionsstörung ist vor und nach der Anwendung eine Hydrierung erforderlich),
    -bei Patienten mit vor- bestehender Niereninsuffizienz (Kreatinin- Clearance < 60 ml/min) oder einer Beeinträchtigung des Gehörs,
    -Während einer Behandlung mit Cisplatin darf nicht gestillt werden.
    -Die gleichzeitige Verabreichung von Gelb- fieberimpfstoff ist kontraindiziert
    -Die Kombination mit prophylaktisch eingesetztem Phenytoin ist kontraindiziert

    • Kontrainikationen Ifosphamid:
    -Überempfindlichkeit gegen den Wirkstoff oder einen der sonstigen Bestandteile (Harnstoff, Natriumchlorid, Natriummonohydrogenphosphat-Dihydrat (Ph.Eur.), Salz- säure 36%, Wasser für Injektionszwecke,
    -schwerer Beeinträchtigung der Knochenmarkfunktion (insbesondere bei zytostatisch und/oder strahlentherapeutisch vor- behandelten Patienten),
    -floriden Infektionen,
    -eingeschränkter Nierenfunktion und/oder Harnabflussbehinderungen,
    -Blasenentzündung (Zystitis),
    -Schwangerschaft und Stillzeit
    -Wegen des Risikos einer möglichen ZNS- Toxizität von Ifosfamid ist eine sorgfältige Beobachtung des Patienten erforderlich. Im Falle einer Enzephalopathie ist die Behandlung mit Ifosfamid abzubrechen und auch nicht wieder aufzunehmen
    E.5 End points
    E.5.1Primary end point(s)
    Disease Free Survival (DFS):Als primäre Zielgröße wird das erkrankungsfreie Überleben (Disease free survival DFS ermittelt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    5 Jahre nach Therapieende
    E.5.2Secondary end point(s)
    Overall Survival (OS), Lebensqualitätsanalyse, Toxizität
    E.5.2.1Timepoint(s) of evaluation of this end point
    5 Jahre nach Thearpieende
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 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 concerned5
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years10
    E.8.9.1In the Member State concerned months
    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: 534
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients No
    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 state534
    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)
    Therapie nach Standard of Care; klinischer Routine und im Ermessen des behandelnden Arztes
    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 Decision2019-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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