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    Summary
    EudraCT Number:2015-004172-30
    Sponsor's Protocol Code Number:PREPARE
    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:2021-04-16
    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 number2015-004172-30
    A.3Full title of the trial
    Prevention of paclitaxel-related neurological side effects with lithium – a randomized, double-blind, placebo-controlled, explorative proof-of-concept phase II clinical trial to counteract chemotherapy induced neurotoxicity
    Prävention von Paclitaxel-bedingten neurologischen Nebenwirkungen mit Lithium - eine randomisierte, doppelt-verblindete, plazebokontrollierte, explorative Proof-of-Concept-Studie der klinischen Phase II zur Prävention von Chemotherapie induzierter Neurotoxizität
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prevention of paclitaxel-related neurological side effects with lithium to counteract chemotherapy induced neurotoxicity
    Prävention von Paclitaxel-bedingten neurologischen Nebenwirkungen mit Lithium zur Prävention von Chemotherapie induzierter Neurotoxizität
    A.4.1Sponsor's protocol code numberPREPARE
    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 supportCharité – Universitätsmedizin Berlin
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité – Universitätsmedizin Berlin
    B.5.2Functional name of contact pointDepartment of Neurology / NCRC
    B.5.3 Address:
    B.5.3.1Street AddressCharitéplatz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code10117
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930450 560 102
    B.5.5Fax number+4930450 560 932
    B.5.6E-mailprepare-studie@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 No
    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 nameQuilonum® retard
    D.3.4Pharmaceutical form Capsule, hard
    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 INNLITHIUM CARBONATE
    D.3.9.1CAS number 554-13-2
    D.3.9.4EV Substance CodeSUB14375MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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.3.2Product code L01CD01
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 number700 to 1500
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Breast cancer patients scheduled for treatment with paclitaxel chemotherapy
    Brustkrebspatientinnen, bei denen eine Behandlung mit Paclitaxel-Chemotherapie vorgesehen ist
    E.1.1.1Medical condition in easily understood language
    Breast cancer patients scheduled for treatment with paclitaxel chemotherapy
    Brustkrebspatientinnen, bei denen eine Behandlung mit Paclitaxel-Chemotherapie vorgesehen ist
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    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
    The main objective of this proof-of-concept exploratory clinical trial is to test the hypothesis that a co-medication with lithium carbonate (Quilonum® retard) is able to reduce the burden of chemotherapy induced neuropathy (CIN) as measured by the “Total Neuropathy Score reduced” (TNSr) in breast cancer patients undergoing neurotoxic chemotherapy with weekly (q1w) or biweekly (q2w) paclitaxel infusions.
    Das Hauptziel dieser exploratorischen klinischen Proof-of-Concept-Studie ist es, die Hypothese zu prüfen, dass eine Co-Medikation mit Lithiumcarbonat (Quilonum® retard) die Belastung durch Chemotherapie-induzierte Neuropathie (CIN) – gemessen am "Total Neuropathy Score reduced" (TNSr) – bei Brustkrebspatientinnen, die sich einer neurotoxischen Chemotherapie mit wöchentlichen (q1w) oder zweiwöchentlichen (q2w) Paclitaxel-Infusionen unterziehen, reduziert.
    E.2.2Secondary objectives of the trial
    To examine whether:
    Co-medication with lithium carbonate
    - results in a reduced number of patients with moderate to severe CIN
    - leads to less intake or lower doses of atypical pain medication
    - leads to fewer and less severe self-reported symptoms of CIN
    - improves the patients' quality of life
    - can reduce cognitive impairment caused by paclitaxel
    - can reduce the decrease in hippocampal volume and changes in structural connectivity
    - leads to lower concentrations of neurofilament light chain in serum
    Patients with co-medication of lithium carbonate tolerate higher cumulative doses of paclitaxel
    Im Rahmen der klinischen Prüfung soll untersucht werden, ob:
    die Co-Medikation mit Lithiumcarbonat
    - zu einer reduzierten Anzahl von Patientinnen mit mäßiger bis schwerer CIN führt
    - zu geringeren Einnahme oder niedrigeren Dosen atypischer Schmerzmittel führt
    - zu weniger und weniger schweren selbstberichteten Symptomen einer CIN führt
    - die Lebensqualität der Patientinnen verbessert
    - die durch Paclitaxel verursachte kognitive Beeinträchtigung verringern kann
    - die Volumenreduktion des Hippocampus und Veränderungen der strukturellen Konnektivität reduzieren kann
    - zu niedrigeren Konzentrationen des Neurofilament-Leichtkettenproteins im Serum führt
    Patientinnen mit dem Kombinationspräparat Lithiumcarbonat höhere kumulative Dosen von Paclitaxel tolerieren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Written informed consent is present
    - The patient has the capacity to give consent (she is able to understand the nature and anticipated effects/side effects of the proposed medical intervention.)
    - Age 18-70 years
    - Recent diagnosis of breast cancer to be treated with weekly or biweekly paclitaxel therapy
    - Karnofsky index ≥70 %
    - Schriftliche Zustimmung liegt vor
    - Die Patientin ist in der Lage, ihre Einwilligung zu geben (sie ist in der Lage, das Wesen und die zu erwartende Wirkung/ Nebenwirkungen der vorgeschlagenen medizinischen Intervention zu verstehen).
    - Alter 18 -70 Jahre
    - histologische Diagnose von Brustkrebs, der mit wöchentlicher oder zwei-wöchentlicher Paclitaxel-Chemotherapie behandelt werden soll
    - Karnofsky-Index ≥70 %
    E.4Principal exclusion criteria
    -The patient is pregnant or breastfeeding
    -The patient with childbearing potential is not willing to use an acceptable form of contraception.
    -The patient is unwilling to consent to saving, processing and propagation of pseudonymized medical data for study reasons.
    -The patient did or does participate in other interventional trials (6 months before and at the time of this trial)
    -The patient is legally detained in an official institution
    -The patient is an employee of the investigator study site, or a family member of the employees or the investigators, or otherwise dependent on the sponsor, the investigators or study physicians.
    -The patient previously received neurotoxic chemotherapy (especially: taxanes, platinum compounds, vinca alcaloids, proteasome inhibitors)
    -The patient has a history of pre-existing neuropathy with a baseline TNSr > 5
    -The patient has a history of current or former alcohol or drug abuse or Carbohydrate Deficient Transferrin (CDT) > 2.4 % or urine drug screening for amphetamine, barbiturates, benzodiazepines, cocaine, methamphetamine, methadone, opiates, tetrahydrocannabinol is positive unless the positive result can be explained by prescribed medications
    -The patient has a cardiac pacemaker or other non-MRI suitable implants
    -Diagnosis of Covid-19 illness
    Lithium carbonate:
    -The patient has a known allergy against Lithium carbonate or other components of the IMP
    -The patient has one of the following confirmed diagnoses: hereditary galactose intolerance, lactase insufficiency or glucose-galactose-malabsorption
    -The patient has one of the following diagnoses: Brugada-Syndrome, Myasthenia gravis, M. Addison, myeloid leukemia, psoriasis, epilepsy, severe cardiac arrhythmia, severe hyponatremia, severe dehydration, severe hypothyreoidism, acute myocardial infarction, acute kidney failure
    -The patient’s family history is positive for confirmed lethal sudden cardiac arrest
    -The patient uses phenytoin, fosphenytoin, carbamazepine, methyldopa, tricyclic antidepressants
    -The patient has chronic renal disease with a GFR <60ml/min/1.73m2
    Placebo:
    -Allergy to cellulose or lactose
    Paclitaxel:
    -The patient has a known allergy against paclitaxel or other components of the standard-medication (SMP)
    -The patient has a diagnosis of severe liver failure, based on routine standard care bloodwork
    -Die Patientin ist schwanger oder stillt.
    -Die Patientin im gebärfähigen Alter ist nicht bereit ist, eine akzeptable Form der Empfängnisverhütung zu verwenden.
    -Die Patientin ist nicht bereit, der Speicherung, Verarbeitung und Weitergabe von pseudonymisierten medizinischen Daten aus Studiengründen zuzustimmen.
    -Die Patientin nahm oder nimmt an anderen interventionellen Studien teil (6 Monate vor und zum Zeitpunkt dieser Studie)
    -Die Patientin ist rechtmäßig in einer offiziellen Einrichtung untergebracht
    -Die Patientin ist eine Mitarbeiterin der Prüfstelle oder ein Familienmitglied der Mitarbeiter oder der Prüfer oder anderweitig vom Sponsor, den Prüfern oder den Prüfärzten abhängig.
    -Die Patientin hat in der Vergangenheit bereits eine neurotoxische Chemotherapie erhalten (insbesondere: Taxane, Platinverbindungen, Vincaalkaloide, Proteasom-Inhibitoren)
    -Die Patientin hat eine vorbestehende Neuropathie mit einem Ausgangs-TNSr > 5
    -Die Patientin hat eine Vorgeschichte von aktuellem oder früherem Alkohol- oder Drogenmissbrauch oder einen CDT Wert >2.4 % oder ein nicht durch verschriebene Medikamente bedingtes positives Ergebnis des Drogenscreenings auf Amphetamine, Barbiturate, Benzodiazepine, Kokain, Methamphetamin, Methadon, Opiate und Tetrahydrocannabinol im Urin.
    -Die Patientin hat einen Herzschrittmacher oder andere nicht MRT-geeignete Implantate
    -Diagnose einer Covid-19 Erkrankung
    Lithiumcarbonat:
    -Die Patientin hat eine bekannte Allergie gegen Lithiumcarbonat oder andere Bestandteile des IMP
    -Die Patientin hat eine der folgenden gesicherten Diagnosen: hereditäre Galaktose-Intoleranz, Laktase-Insuffizienz oder Glukose-Galaktose-Malabsorption
    -Die Patientin hat eine der folgenden Diagnosen: Brugada-Syndrom, Myasthenia gravis, M. Addison, myeloische Leukämie, Psoriasis, Epilepsie, schwere Herzrhythmusstörungen, schwere Hyponatriämie, schwere Dehydrierung, schwerer Hypothyreoidismus, akuter Myokardinfarkt, akutes Nierenversagen
    -Die Patientin weist eine familiäre Häufung von gesichertem plötzlichem Herztot auf
    -Die Patientin nimmt folgende Medikamente ein: Phenytoin, Fosphenytoin, Carbamazepin, Methyldopa, trizyklischen Antidepressiva
    -Die Patientin hat eine chronische Nierenerkrankung mit einer GFR <60ml/min/1,73m2
    Placebo:
    -Allergie gegenüber Cellulose oder Laktose
    Paclitaxel:
    -Die Patientin hat eine bekannte Allergie gegen Paclitaxel oder andere Bestandteile des Standardmedikaments (SMP)
    -Die Patientin hat schweres Leberversagen, bereits erkennbar in der Routinelabordiagnostik
    E.5 End points
    E.5.1Primary end point(s)
    Value of the “Total Neuropathy Score reduced” (TNSr) at 2 weeks after last paclitaxel chemotherapy. The score has a range of 0 to 28 points.
    Nummerischer Wert des "Total Neuropathy Score reduced" (TNSr) erhoben 2 Wochen nach der letzten Paclitaxel-Infusion. Der Score hat eine Spanne von 0 bis 28 Punkten.
    E.5.1.1Timepoint(s) of evaluation of this end point
    2 weeks after last paclitaxel chemotherapy
    2 Wochen nach der letzten Paclitaxel-Infusion
    E.5.2Secondary end point(s)
    • Indicator of mild vs. moderate vs. severe CIN as assessed by the TNSr at 2 weeks after last paclitaxel infusion: mild 1-10 points, 11-19 points moderate, 20-28 points severe.
    • Amount and dose of pain medication for CIN at 2 weeks after last paclitaxel infusion.
    • Number and cumulative dose of completed paclitaxel chemotherapy cycles at 2 weeks after last paclitaxel infusion.
    • Patient-reported severity of CIN assessed with the European Organisation for Research and Treatment of Cancer (EORTC) CIPN20 questionnaire at 2 weeks after the last paclitaxel infusion. The score has a range of 20 to 80 points.
    • Patient-reported quality of life assessed with the EORTC-QLQ-C30 quality of life questionnaire at 2 weeks after the last paclitaxel infusion. The score has a range from 30 to 126 points.
    • Patient-reported symptoms of anxiety and depression assessed with the Patient Health Questionnaire for Anxiety and Depression (PHQ-4) at 2 weeks after last paclitaxel infusion. The score has a range from 0 to 12 points.
    • Severity of cognitive impairment, tested with the CANTAB system (Cambridge Neuropsychological Test Automated Battery) at 2 respectively 6 weeks after the last paclitaxel infusion (V16 q1w and q2w).
    • Hippocampal volume and changes in structural connectivity measured by brain MRI at 2 respectively 6 weeks after the last paclitaxel infusion (V16 q1w and q2w).
    • Axonal damage assessed by serum neurofilament light chain (NFL) at 2 weeks after the last paclitaxel infusion.
    - Indikator für milde vs. mäßige vs. schwere CIN, bewertet im TNSr gemessen 2 Wochen nach der letzten Paclitaxelinfusion: mild 1-10 Punkte, mäßig 11-19 Punkte, schwer 20-28 Punkte.
    - Anzahl und Dosis von Schmerzmedikation zur symptomatischen Behandlung der CIN gemessen 2 Wochen nach der letzten Paclitaxelinfusion.
    - Anzahl und kumulative Dosis der verabreichten Paclitaxel-Infusionen gemessen 2 Wochen nach der letzten Paclitaxelinfusion.
    - Der von den Patientinnen angegebene Schweregrad der CIN berechnet mit dem CIPN20-Fragebogen der Europäischen Organisation für Krebsforschung und -Behandlung (EORTC) gemessen 2 Wochen nach der letzten Paclitaxelinfusion. Die Spanne liegt zwischen 20 bis 80 Punkten.
    - Mit dem EORTC-QLQ-C30-Fragebogen ermittelte Beeinträchtigung der Lebensqualität erhoben 2 Wochen nach der letzten Paclitaxelinfusion. Der Score hat eine Spanne von 30 bis 126 Punkten.
    - Angst- und Depressionsscreening, erhoben mit dem Patient Health Questionnaire for Anxiety and Depression (PHQ-4) 2 Wochen nach der letzten Paclitaxelinfusion. Der Score hat einen Bereich von 0 bis 12 Punkten.
    - Schweregrad der kognitiven Beeinträchtigungen, getestet mit dem CANTAB-System (Cambridge Neuropsychological Test Automated Battery) erhoben 2 bzw. 7 Wochen nach der letzten Paclitaxelinfusion (V16 q1w und q2w).
    - Hippocampusvolumen und Veränderungen der strukturellen Konnektivität, gemessen mit dem Gehirn-MRT 2 bzw. 7 Wochen nach der letzten Paclitaxelinfusion (Studienvisite V16 q2w und q1w).
    - Axonale Schädigung, gemessen mittels Neurofilament-Leichtkettenprotein (NFL) im Serum 2 Wochen nach der letzten Paclitaxelinfusion.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 weeks after last paclitaxel infusion
    2 Wochen nach der letzten Paclitaxel-Infusion
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy 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 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 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 concerned8
    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
    LVLS
    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 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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 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 state84
    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 completing all the protocol treatment and visits, patients will continue with regular visits according to usual practice.
    Nach Abschluss der klinischen Prüfung werden die Patientinnen ihre übliche Behandlung erhalten.
    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 Decision2021-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-13
    P. End of Trial
    P.End of Trial StatusOngoing
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