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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-005910-17
    Sponsor's Protocol Code Number:KKSH176
    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:2021-02-10
    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 number2020-005910-17
    A.3Full title of the trial
    Phase 2 multicenter study investigating the tolerability and efficacy of UV1 vaccine in patients with recurrent or metastatic PD-L1 positive (CPS≥1) head and neck squamous cell carcinoma planned for first-line treatment with pembrolizumab
    Multizentrische Phase-2-Studie zur Untersuchung der Verträglichkeit und Wirksamkeit des UV1-Impfstoffs bei Patienten mit rezidivierten oder metastasierten PD-L1-positiven (CPS≥1) Plattenepithelkarzinomen des Kopfes und Halses, die für eine Erstlinienbehandlung mit Pembrolizumab vorgesehen sind
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II study of pembrolizumab alone or in combination with UV1 cancer vaccine in patients with recurrent or metastatic PD-L1-positive (CPS≥1) head and neck squamous cell carcinoma.
    Phase-II-Studie mit Pembrolizumab allein oder in Kombination mit dem UV1-Krebsimpfstoff bei Patienten mit rezidiviertem oder metastasiertem PD-L1-positivem (CPS≥1) Plattenepithelkarzinom im Kopf- Hals-Bereich
    A.3.2Name or abbreviated title of the trial where available
    FOCUS
    FOCUS
    A.4.1Sponsor's protocol code numberKKSH176
    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 SponsorMartin-Luther-Universität Halle-Wittenberg
    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 supportUltimovacs ASA
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversitätsklinikum Halle
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressErnst-Grube-Strasse 40
    B.5.3.2Town/ cityHalle (Saale)
    B.5.3.3Post code06120
    B.5.3.4CountryGermany
    B.5.4Telephone number+493455572054
    B.5.5Fax number+493455572950
    B.5.6E-mailmascha.binder@uk-halle.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.2.5The 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 nameUV-1
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1331848-79-3
    D.3.9.3Other descriptive nameP719-20
    D.3.9.4EV Substance CodeSUB171636
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.450
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 1221082-45-6
    D.3.9.3Other descriptive nameP725
    D.3.9.4EV Substance CodeSUB171638
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.225
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot available
    D.3.9.1CAS number 524061-04-9
    D.3.9.3Other descriptive nameP728
    D.3.9.4EV Substance CodeSUB171637
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.225
    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.2.1.1.1Trade name Leukine
    D.2.1.1.2Name of the Marketing Authorisation holderPartner Therapeutics, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 Lyophilisate for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSARGRAMOSTIM
    D.3.9.1CAS number 123774-72-1
    D.3.9.3Other descriptive nameGM-CSF
    D.3.9.4EV Substance CodeSUB10450MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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 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.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
    Recurrent or metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
    Rezidiviertes oder metastasiertes Plattenepithelkarzinom des Kopf-Hals Bereiches (HNSCC)
    E.1.1.1Medical condition in easily understood language
    Recurrent or metastatic head and neck squamous cell carcinoma.
    Rezidiviertes oder metastasiertes Plattenepithelkarzinom des Kopf Hals Bereichs (HNSCC)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10060121
    E.1.2Term Squamous cell carcinoma of head and neck
    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
    The primary objective of this study is to determine the clinical performance of the UV1 vaccine as add on to standard pembrolizumab treatment in patients with recurrent or metastatic PD-L1 positive (CPS >=1%) head and neck squamous cell carcinoma in terms of progression free survival according to iRECIST (PFSR@6 months).
    Das primäre Ziel dieser Studie ist die Ermittlung der klinischen Leistungsfähigkeit des UV1-Vakzin als Zusatz zur Standardbehandlung mit Pembrolizumab bei Patienten mit rezidiviertem oder metastasiertem PD-L1-positivem (CPS >=1%) Plattenepithelkarzinom des Kopf-Hals-Bereiches anhand des progressionsfreien Überlebens nach iRECIST (PFSR@6 Monate).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to determine the efficacy in terms of overall survival and objective response rate according to iRECIST. Further secondary objectives are the assessment of the rate of immune responses against hTERT peptides (as measured by 3H-Thymidine proliferation and IFNgamma ELISPOT assays) and the rate of clearance of ctDNA from blood on treatment. Another secondary objective is to investigate the Safety and tolerability of the UV1 vaccine in combination with pembrolizumab (acc. to NCI CTC AE v4.03 and to the obtained data on vital signs, clinical parameters and feasibility of the regimen). Moreover, this study will explore patient subgroups most likely deriving benefit from a targeted immunotherapy approach combining a checkpoint inhibitor with a cancer vaccine and help to establish liquid biopsy tumor monitoring in HNSCC.
    Sekundäre Ziele sind die Ermittlung der Wirksamkeit in Bezug auf das Gesamtüberleben und die objektive Ansprechrate gemäß iRECIST. Weitere sekundäre Ziele sind die Bewertung der Rate der Immunreaktionen gegen hTERT-Peptide (gemessen durch 3H-Thymidin-Proliferations- und IFNgamma-ELISPOT-Assays) und die Rate der Clearance von ctDNA aus dem Blut unter Behandlung. Ein weiteres sekundäres Ziel ist die Untersuchung der Sicherheit und Verträglichkeit des UV1-Impfstoffs in Kombination mit Pembrolizumab (gemäß NCI CTC AE v4.03 und den erhaltenen Vitalparametern, klinischen Parametern und der Durchführbarkeit des Therapieregimes). Darüber hinaus sollen die Patientensubgruppen ermittelt werden, die am ehesten von einem gezielten Immuntherapie-Ansatz profitieren, der einen Checkpoint-Inhibitor mit einem Krebsimpfstoff kombiniert, und dazu beitragen, ein Tumor-Monitoring mittels Flüssigbiopsie bei HNSCC zu etablieren.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Males and Females at least 18 years of age
    - Histologically confirmed diagnosis of a non-resectable recurrent or metastatic head and neck squamous cell carcinoma
    - At least one measurable tumor lesion as per RECIST v1.1, (Scan not older than 4 weeks before randomization)
    - Eligible for pembrolizumab monotherapy (PD-L1 CPS >/= 1%) and adequate laboratory parameters for pembrolizumab monotherapy as assessed by the investigator
    - ECOG-performance score 0-2
    - Written informed consent obtained according to international guidelines and local laws
    - Ability to understand and give informed consent.
    - Safe contraception measures for males and females. Procedures with a pearl index of less than 1% apply as safe pregnancy prevention measures.
    - Männer und Frauen, mindestens 18 Jahre und älter
    - Histologisch bestätigtes nicht resektables rezidivierendes oder metastasiertes Plattenepithelkarzinoms des Kopfes und Halses
    - Mindestens eine messbare Tumorläsion gemäß RECIST v1.1, (Scan nicht älter als 4 Wochen vor Randomisierung)
    - Geeignet für eine Pembrolizumab-Monotherapie (PD-L1 CPS >/= 1%) und adäquate Laborparameter für eine Pembrolizumab-Monotherapie nach Beurteilung durch den Prüfarzt
    - ECOG-Performance-Score 0-2
    - Schriftliche Einwilligungserklärung gemäß internationalen Richtlinien und lokalen Gesetzen
    - Sichere Verhütungsmaßnahmen für Männer und Frauen. Als sichere Schwangerschaftsverhütungsmaßnahmen gelten Verfahren mit einem Pearl-Index von weniger als 1%.
    E.4Principal exclusion criteria
    - Patients for whom a combination therapy of a checkpoint inhibitor and a chemotherapy is deemed necessary in the opinion of the investigator
    - Participation in another interventional study simultaneously and within the last 30 days prior to inclusion (registries or observational studies allowed)
    - Concurrent malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome
    - Active, known, or suspected autoimmune disease requiring systemic treatment
    - Concomitant therapy with systemic immune suppression (use of chronic systemic steroid medication (up to 5 mg/day prednisolone equivalent is allowed; patients using physiological replacement doses of prednisone for adrenal or pituitary insufficiency are eligible)
    - History of severe autoimmune disorder or history of organ transplant
    - Any serious or uncontrolled medical disorder or active infection that may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug.
    - Significant acute or chronic infections including, among others (test not older tan 4 weeks prior to randomization): Any positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS), Any positive test result for hepatitis B virus or hepatitis C virus indicating acute or chronic infection.
    - Intake of drug products which potentially cause adverse interactions with the medicinal product under investigation
    - Diseases/medical findings which may have a significant effect on the target variables and thus mask or inhibit the therapeutic effect under investigation
    - Pregnancy or lactation
    - (Bacterial) infections requiring systemic antibiotic treatment within 2 weeks prior to first dose of study treatment (depending on group assignment: either prior to first UV1 or prior to first pembrolizumab administration)
    - History of allergy or hypersensitivity to study drug or any constituent of the products
    - Patienten, bei denen eine Kombinationstherapie aus einem Checkpoint-Inhibitor und einer Chemotherapie nach Meinung des Prüfarztes notwendig ist
    - Teilnahme an einer anderen interventionellen Studie gleichzeitig und innerhalb der letzten 30 Tage vor dem Einschluss (Register- oder Beobachtungsstudien erlaubt)
    - Andere maligne Erkrankungen innerhalb der letzten 5 Jahre vor dem Einschluss, mit Ausnahme von solchen mit einem vernachlässigbaren Risiko für Metastasen oder Tod (z. B. erwartetes 5-Jahres-OS > 90 %), die mit erwartetem kurativem Ergebnis behandelt werden
    - Aktive, bekannte oder vermutete Autoimmunerkrankung, die eine systemische Behandlung erfordert (Anwendung von chronischer systemischer Steroidmedikation (bis zu 5 mg/Tag Prednisolon-Äquivalent ist erlaubt; Patienten, die physiologische Ersatzdosen von Prednison für Nebennieren- oder Hypophysen-Insuffizienz verwenden, sind zugelassen)
    - Schwere Autoimmunerkrankung oder Organtransplantation in der Vorgeschichte
    - Jede schwerwiegende oder unkontrollierte medizinische Erkrankung oder aktive Infektion, die das Risiko im Zusammenhang mit der Studienteilnahme oder der Verabreichung des Studienmedikaments erhöhen oder die Fähigkeit des Patienten, das Studienmedikament zu erhalten, beeinträchtigen könnte.
    - Signifikante akute oder chronische Infektionen, u.a. (Test nicht älter als 4 Wochen vor der Randomisierung): positiver HIV-Test oder bekanntes erworbenes Immundefizienz-Syndrom (AIDS), positive Testergebnis auf Hepatitis-B-Virus oder Hepatitis-C-Virus, das auf eine akute oder chronische Infektion hinweist.
    - Einnahme von Arzneimitteln, die potentiell unerwünschte Wechselwirkungen mit dem zu untersuchenden Arzneimittel verursachen können
    - Krankheiten/medizinische Befunde, die einen signifikanten Einfluss auf die Zielvariablen haben können und somit den zu untersuchenden therapeutischen Effekt maskieren oder hemmen
    - Schwangerschaft oder Laktation
    - (Bakterielle) Infektionen, die eine systemische Antibiotikabehandlung innerhalb von 2 Wochen vor der ersten Dosis der Studienbehandlung erfordern (je nach Gruppenzuordnung: entweder vor der ersten UV1- oder vor der ersten Pembrolizumab-Gabe)
    - Vorgeschichte einer Allergie oder Überempfindlichkeit gegen das Studienmedikament oder einen Bestandteil der Produkte.
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival rate at 6 months (PFSR@6) according to iRECIST
    Progressionsfreies Überleben nach 6 Monaten (PFSR@6) gemäß iRECIST
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from study entry
    6 Monate nach Studienbeginn
    E.5.2Secondary end point(s)
    - progression free survival (PFS)
    - overall survival
    - objective response rate (ORR) according to iRECIST
    - duration of response
    - rate of immune responses against hTERT peptides (as measured by 3H-Thymidine proliferation and IFNgamma ELISPOT assays)
    - rate of clearance of ctDNA from blood on treatment
    - Safety and tolerability
    - progressionsfreies Überleben (PFS)
    - Gesamtüberleben
    - objektive Ansprechrate (CR + PR) nach iRECIST
    - Dauer des Ansprechens
    - Rate der Immunantworten gegen hTERT-Peptide (gemessen mit 3H-Thymidin-Proliferations- und IFNgamma-ELISPOT-Assays)
    - Rate der Clearance von ctDNA aus dem Blut unter der Behandlung
    - Sicherheit und Verträglichkeit
    E.5.2.1Timepoint(s) of evaluation of this end point
    - time point of tumor progression (PFS)
    - death of the patient (OS)
    - 6 months from study entry (ORR)
    - day 1, week 5, 8, 14, 30 days after last dose of study drug (ALD), 3 months ALD, 6 months ALD, at disease progression (rate of immune responses against hTERT peptides, rate of clearance of ctDNA from blood on treatment)
    - Until 30 days after last administration of study therapy (toxicity)
    - Zeitpunkt der Tumorprogression (PFS)
    - Tod des Patienten (OS)
    - 6 Monate ab Studieneintritt (ORR)
    - Tag 1, Woche 5, 8, 14, 30 Tage nach der letzten Gabe des Studienmedikaments (ALD), 3 Monate ALD, 6 Monate ALD, bei Progress (Rate der Immunantworten gegen hTERT-Peptide, Rate der Clearance von ctDNA aus dem Blut unter der Behandlung)
    - Bis 30 Tage nach der letzten Verabreichung der Studientherapie (Toxizität)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled 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 Yes
    E.8.1.7.1Other trial design description
    zweiarmig, nicht-vergleichend
    two-armed, non-comparative
    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 concerned10
    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
    Closed database after LVLP
    Datenbankschluss nach der letzten Visite des letzten Patienten
    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: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state75
    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 end of the study, the further treatment and therapy will be performed according to the German treatment guidelines / clinical routine and is left to the investigator’s discretion.
    Nach Beendigung der Studie erfolgt die weitere Behandlung und Therapie entsprechend der deutschen Behandlungsrichtlinien / klinischen Routine und liegt im Ermessen des Prüfarztes.
    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 Decision2021-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-01
    P. End of Trial
    P.End of Trial StatusOngoing
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