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    Summary
    EudraCT Number:2021-000986-34
    Sponsor's Protocol Code Number:CaboAveNEC
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-09-01
    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 - PEI
    A.2EudraCT number2021-000986-34
    A.3Full title of the trial
    A phase II, open-label, multicenter trial to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3).
    Eine offene, multizentrische Phase II-Studie zur Untersuchung der Wirksamkeit und Sicherheit von Cabozantinib in Kombination mit Avelumab bei Patienten mit fortgeschrittenen neuroendokrinen Neoplasien G3 (NEN G3), welche refraktär auf eine Standard-Chemotherapie sind.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Cabozantinib in combination with Avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3).
    Cabozantinib in Kombination mit Avelumab bei Patienten mit fortgeschrittenen neuroendokrinen Neoplasien G3 (NEN G3), welche refraktär auf eine Standard-Chemotherapie sind.
    A.3.2Name or abbreviated title of the trial where available
    CaboAveNEC
    CaboAveNEC
    A.4.1Sponsor's protocol code numberCaboAveNEC
    A.5.4Other Identifiers
    Name:Ipsen trial codeNumber:ADE60000075
    Name:Merck trial codeNumber:MS100070-0048
    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 SponsorUniversity Medical Center of the Johannes Gutenberg-University Mainz
    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 supportIpsen Pharma GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center of the Johannes Gutenberg-University Mainz
    B.5.2Functional name of contact pointUniv.-Prof. Dr. med. Matthias Weber
    B.5.3 Address:
    B.5.3.1Street AddressLangenbeckstr. 1
    B.5.3.2Town/ cityMainz
    B.5.3.3Post code55131
    B.5.3.4CountryGermany
    B.5.4Telephone number+496131177260
    B.5.5Fax number+496131175608
    B.5.6E-mailmmweber@uni-mainz.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 Bavencio 20 mg/ml Konzentrat
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameAvelumab
    D.3.2Product code MSB0010718C
    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 INNAVELUMAB
    D.3.9.3Other descriptive nameBavencio
    D.3.9.4EV Substance CodeSUB180078
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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.2.1.1.1Trade name Cabometyx 20 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCabozantinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.2.1.1.1Trade name Cabometyx 40 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCabozantinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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.2.1.1.1Trade name Cabometyx 60 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCabozantinib
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabozantinib
    D.3.9.1CAS number 849217-68-1
    D.3.9.4EV Substance CodeSUB93452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    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
    Advanced neuroendocrine neoplasias G3 (NEN G3) (excluding SCLC and Merkel cell carcinomas)
    Fortgeschrittene neuroendokrine Neoplasien G3 (NEN G3) (ausgenommen SCLC und Merkelzellkarzinome)
    E.1.1.1Medical condition in easily understood language
    neuroendocrine cancer
    neuroendokriner Krebs
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057270
    E.1.2Term Neuroendocrine carcinoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary study objective is to assess the clinical activity of the combination therapy of Cabozantinib with Avelumab in comparison to monotherapy with avelumab in the AveNEC trial (EudraCT No.: 2016-004373-40) in patients with progressive Neuroendocrine Neoplasias G3 (NEN G3) after standard chemotherapy. The primary end point is the disease control rate (DCR) according to iRECIST after 16 weeks from start of treatment until documented disease progression (PD). The tumor assessment is done every 8 weeks for the first 6 month and every 12 weeks thereafter.
    Primäres Studienziel ist die Beurteilung der klinischen Aktivität der Kombinationsbehandlung von Cabozantinib und Avelumab im Vergleich zur Monotherapie mit Avelumab in der AveNEC-Studie (EudraCT Nr. 2016-004373-40) bei Patienten mit progressiven neuroendokrinen Neoplasien G3 (NEN G3) nach Standard-Chemotherapie. Der primäre Endpunkt ist die Krankheitskontrollrate (DCR) gemäß iRECIST nach 16 Wochen ab Behandlungsbeginn bis zum dokumentierten Fortschreiten der Erkrankung (PD). Die Tumorbeurteilung erfolgt alle 8 Wochen in den ersten 6 Monaten und danach alle 12 Wochen.
    E.2.2Secondary objectives of the trial
    Secondary study objectives include the objective response rate (ORR), the duration of disease control (DDC), best overall response (BOR), the progression-free survival time (PFS), the overall survival (OS), the quality of life (QoL) and the safety and tolerability. Exploratory study objectives include correlation of subclassification of the NEN G3 (NET G3 vs NEC) and tumor immune microenvironment (e.g. PD-L1 expression, tumor infiltrating lymphocytes (TIL)) with tumor response and (when tumor tissue on/after treatment is available) effect of treatment on tumor microenvironment. Comparison of the efficacy and tolerability of the combination of Cabozantinib and Avelumab to the monotherapy with avelumab in the AveNEC trial (EudraCT No.: 2016-004373-40) and evaluation of tumor growth rate (TGR).
    Sekundäre Studienziele sind die objektive Ansprechrate (ORR), die Dauer der Krankheitskontrolle (DDC), das beste Gesamtansprechen (BOR), die progressionsfreie Überlebenszeit (PFS), das Gesamtüberleben (OS), die Lebensqualität (QoL) sowie die Sicherheit und Verträglichkeit. Explorative Studienziele umfassen die Korrelation der Subklassifikation des NEN G3 (NET G3 vs. NEC) und der Immunmikroumgebung des Tumors (z. B. PD-L1-Expression, tumorinfiltrierende Lymphozyten (TIL)) mit dem Tumoransprechen und (wenn Tumor-gewebe bei/nach der Behandlung zur Verfügung steht) die Wirkung der Behandlung auf die Tumormikro-umgebung. Zudem sollen die Wirksamkeit und die Verträglichkeit der Kombination von Cabozantinib und Avelumab mit der Avelumab-Monotherapie in der AveNEC-Studie verglichen werden (EudraCT-Nr.: 2016-004373-40) und die Tumorwachstumsraten (TGR) ausgewertet werden.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Histologically proven neuroendocrine neoplasia NEN G3 (WHO 2010/2019)
    - One block or 20 slides (4 microns) of archival tumor tissue to perform central pathological review and biomarker assessment and for translational research
    - No curative option available
    - Progression after at least one chemotherapy (platinum based or STZ/TEM/DTIC based chemotherapy)
    - Presence of measurable disease as per RECIST1.1 criteria
    - Adequate organ and bone marrow function
    - ECOG Performance Status 0 – 1
    - Written informed consent
    - Alter ≥ 18 Jahre
    - Histologisch gesicherte neuroendokrine Neoplasie NEN G3 (WHO 2010/2019)
    - Ein Block oder 20 Schnitte (4 Mikrometer) archiviertes Tumorgewebe zur zentralen pathologischen Überprüfung und Biomarker-Bewertung sowie für die translationale Forschung
    - Keine kurative Option verfügbar
    - Progression nach mindestens einer Chemotherapie (Platin-basierte Chemotherapie oder STZ/TEM/DTIC-basierte Chemotherapie)
    - Vorhandensein einer messbaren Erkrankung nach RECIST1.1-Kriterien
    - Adäquate Organ- und Knochenmarkfunktion
    - ECOG Performance Status 0 – 1
    - Unterschriebene Einwilligungserklärung


    E.4Principal exclusion criteria
    - Merkel Cell carcinoma (MCC) or small cell lung cancer (SCLC)
    - Typical or Atypical Carcinoid of the lung with a Ki67 < 20%
    - Prior therapy with any TKI or immune therapy
    - Neuroendocrine tumors that are potentially curable by surgery
    - Major surgery within 4 weeks before first dose of study medication. Complete wound
    healing must be observed at least 10 days prior to enrollment.
    - Patients who are at increased risk for severe haemorrhage
    - TACE, TAE, SIRT or PRRT within 8 weeks before first dose of study medication
    - Patients pretreated with Interferon as last treatment line prior to study entry
    - Concurrent anticancer treatment
    - Active infection requiring systemic therapy including, HIV/AIDS, HBV, HCV, Covid 19
    - Severe active autoimmune disease that requires immunomodulatory therapy
    - Uncontrolled hypertension
    - Congestive heart failure or symptomatic coronary artery disease
    - Pregnancy or lactation
    - Vaccination within 4 weeks before the first dose of avelumab and while on trial
    - Merkelzellkarzinom (MCC) oder kleinzelliges Lungenkarzinom (SCLC)
    - Typisches oder Atypisches Karzinoid der Lunge mit Ki67 < 20%- Vorherige Therapie mit einem TKI oder einer Immuntherapie
    - Neuroendokrine Tumoren, welche potentiell durch eine Operation heilbar sind
    - Größere Operation innerhalb von 4 Wochen vor der ersten Dosis der
    Studienmedikation. Eine vollständige Wundheilung muss mindestens 10 Tage vor der
    Aufnahme in die Studie beobachtet werden.
    - Patienten, bei denen ein erhöhtes Risiko für schwere Blutungen besteht
    - TACE, TAE, SIRT oder PRRT innerhalb von 8 Wochen vor Beginn der
    Studienbehandlung
    - Patienten, welche mit Interferon als letzter Behandlungslinie vor Studienbeginn
    vorbehandelt wurden
    - begleitende Anti-Tumor-Behandlung
    - aktive Infektion, die eine systemische Therapie erfordert, einschließlich HIV/AIDS,
    HBV, HCV, Covid-19
    - schwere aktive Autoimmunerkrankung, die eine immunmodulierende Therapie
    erfordert
    - unkontrollierter Bluthochdruck
    - kongestive Herzinsuffizienz oder symptomatische koronare Herzkrankheit
    - Schwangerschaft oder Stillen
    - Impfungen innerhalb von 4 Wochen vor der ersten Dosis von Avelumab und während
    der Studie
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the disease control rate (DCR: CR, PR, SD) according to iRECIST after 16 weeks from start of treatment until documented disease progression (PD).
    Der primäre Endpunkt ist die Krankheitskontrollrate (DCR: CR, PR, SD) gemäß iRECIST, die im Zeitraum von 16 Wochen nach Behandlungsbeginn bis zur dokumentierten
    Krankheitsprogression (PD) gemessen wird.
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks from start of treatment until disease progression (PD)
    16 Wochen nach Behandlungsbeginn bis Krankheitsprogression (PD)
    E.5.2Secondary end point(s)
    - Disease control rate (DCR) at week 8, week 24, week 48
    - Objective response rate (ORR)
    - Best overall response (BOR)
    - Duration of disease control (DDC)
    - Time to response (TTR)
    - Progression-free survival time (PFS)
    - Evaluation of tumor response according to RECIST 1.1
    - Overall survival (OS)
    - Quality of life (QoL) assessed by EORTC QLQ-C30
    - Number, severity, and duration of treatment-emergent AEs according to NCI-CTCAE v5.0
    - Dose reduction of study drugs
    - Treatment interruption or termination of study drugs due to adverse events
    - Krankheitskontrollrate (DCR) in Woche 8, 24 und Woche 48
    - Objektive Ansprechrate (ORR)
    - Bestes Gesamtansprechen (BOR)
    - Dauer der Krankheitskontrolle (DDC)
    - Zeit bis zum Ansprechen (TTR)
    - Progressionsfreie Überlebenszeit (PFS)
    - Bewertung des Tumoransprechens nach RECIST1.1
    - Gesamtüberleben (OS)
    - Lebensqualität (QoL) bewertet anhand EORTC-QLQ-C30
    - Anzahl, Schweregrad und Dauer von behandlungsbedingten unerwünschten Ereignissen nach NCI-CTCAE v5.0
    - Dosisreduktion der Studienmedikamente
    - Behandlungsunterbrechung oder Behandlungsabbruch von Studienmedikamenten aufgrund von unerwünschten Ereignissen
    E.5.2.1Timepoint(s) of evaluation of this end point
    DCR at week 8, week 24, week 48
    ORR, BOR, DDC, TTR, PFS, OS
    Quality of Life (QoL) assessed by EORTC QLQ-C30
    DCR in Woche 8, 24, und Woche 48
    ORR, BOR, DDC, TTR, PFS, OS
    Quality of Life (QoL) bewertet anhand von EORTC QLQ-C30
    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 No
    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 No
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    einarmig, national, multizentrisch
    single arm, national, multicenter
    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 trial1
    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 concerned4
    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 No
    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 Besuch, letzter Patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months36
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state30
    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 the end of the trial the patients will be treated according to best clinical practice.
    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 Decision2021-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-08
    P. End of Trial
    P.End of Trial StatusOngoing
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