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    Summary
    EudraCT Number:2022-002673-28
    Sponsor's Protocol Code Number:NL82177.078.22
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-26
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2022-002673-28
    A.3Full title of the trial
    Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
    Safe Stop IPI-NIVO Trial: Vroegtijdige stopzetting van nivolumab bij het bereiken van een (bevestigde) volledige of gedeeltelijke respons bij patiënten met irresectabel stadium III of gemetastaseerd melanoom behandeld met eerstelijns ipilimumab-nivolumab
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
    Safe Stop IPI-NIVO Trial: Vroegtijdige stopzetting van nivolumab bij het bereiken van een (bevestigde) volledige of gedeeltelijke respons bij patiënten met irresectabel stadium III of gemetastaseerd melanoom behandeld met eerstelijns ipilimumab-nivolumab
    A.3.2Name or abbreviated title of the trial where available
    Safe Stop ipi-nivo
    A.4.1Sponsor's protocol code numberNL82177.078.22
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportErasmus MC
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationErasmus MC
    B.5.2Functional name of contact pointStudy coordinator
    B.5.3 Address:
    B.5.3.1Street AddressDr. Molewaterplein 40
    B.5.3.2Town/ cityRotterdam
    B.5.3.3Post code3015GD
    B.5.3.4CountryNetherlands
    B.5.6E-mailsafestop.ipinivo@erasmusmc.nl
    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 YERVOY
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Meyers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameipilimumab
    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 INNIpilimumab
    D.3.9.1CAS number 477202-00-9
    D.3.9.4EV Substance CodeSUB29397
    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 OPDIVO
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namenivolumab
    D.3.4Pharmaceutical form Concentrate and solvent 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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.4EV Substance CodeSUB122750
    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 KEYTRUDA
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 namepembrolizumab.
    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 INNPembrolizumab
    D.3.9.1CAS number 1374853-91-4
    D.3.9.4EV Substance CodeSUB167136
    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
    Stage III irresectable or metastatic melanoma treated with first-line ipilimumab-nivolumab
    Stadium III irresectabel of gemetastaseerd melanoom behandeld met eerstelijns ipilimumab-nivolumab
    E.1.1.1Medical condition in easily understood language
    Stage III irresectable or metastatic melanoma treated with first-line ipilimumab-nivolumab
    Stadium III irresectabel of gemetastaseerd melanoom behandeld met eerstelijns ipilimumab-nivolumab
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of this study is to evaluate the rate of ongoing response at 12 months after start of treatment in patients with advanced stage III irresectable or metastaticstage IV or metastatic melanoma who are treated with first-line ipilimumab-nivolumab and who early discontinue treatment upon achieving a (confirmed) CR or PR according to RECIST v1.1.
    Het primaire doel van dit onderzoek is het evalueren van de mate van aanhoudende respons 12 maanden na het begin van de behandeling bij patiënten met gevorderd stadium III irresectabel of gemetastaseerd stadium IV of gemetastaseerd melanoom die worden behandeld met eerstelijns ipilimumab-nivolumab en die de behandeling vroegtijdig stopzetten na het behalen van een (bevestigde) CR of PR volgens RECIST v1.1.
    E.2.2Secondary objectives of the trial
    See 'E.5.2 Secondary end point(s)'
    Zie 'E.5.2 Secondary end point(s)'
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 years of age or older
    - irresectable stage III or metastatic melanoma
    - Treated with at least one dose of first-line ipilimumab-nivolumab and considered to be a candidate for maintenance treatment with nivolumab.
    o Previous systemic treatment, including ICIs, in (neo)adjuvant setting for resectable melanoma is allowed
    o In this protocol, nivolumab maintenance is interchangeable with pembrolizumab maintenance therapy.
    - Response evaluation according to RECIST v1.1 using a diagnostic CT documenting target lesions every 12 (-2/+6) weeks from the start of ipilimumab-nivolumab;
    o For patients with CR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed at baseline
    o For patients with PR on a diagnostic CT at response evaluation, a low-dose CT (which is usually part of 18FDG-PET/CT) is allowed if sufficient target lesions are measurable for response evaluation according to RECIST v1.1 criteria.
    o In case of asymptomatic brain metastases prior to start of first-line ipilimumab-nivolumab, intracerebral tumor response should be confirmed using an MRI prior to inclusion
    - Patients should be included after first CR/PR or first confirmed CR/PR according to RECIST v1.1
    o Inclusion should take place no later than 5 weeks after first confirmed CR/PR
    o In case of SD at first response evaluation, confirmed CR/PR is required for inclusion
    o planned and willing to discontinue nivolumab within 4(+1) weeks after inclusion, i.e. first CR/PR or first confirmed CR/PR
    o no later than 9 months after start of treatment with ipilimumab-nivolumab
    - Presence of MRI brain for the screening of brain metastases (prior to discontinuation of ipilimumab-nivolumab)
    - Participants with previously locally treated brain metastases may participate in case they meet the following criteria:
    o completely asymptomatic brain metastases at inclusion
    o MRI of brain at baseline and for response evaluation during treatment
    - Signed and dated informed consent form
    - 18 jaar of ouder
    - irresectabel stadium III of gemetastaseerd melanoom
    - Behandeld met ten minste één dosis eerstelijns ipilimumab-nivolumab en beschouwd als een kandidaat voor onderhoudsbehandeling met nivolumab.
    o Eerdere systemische behandeling, inclusief ICI's, in (neo)adjuvante setting voor reseceerbaar melanoom is toegestaan
    o In dit protocol is nivolumab-onderhoudstherapie uitwisselbaar met pembrolizumab-onderhoudstherapie.
    - Evaluatie van de respons volgens RECIST v1.1 met behulp van een diagnostische CT die doellaesies documenteert om de 12 (-2/+6) weken vanaf het begin van ipilimumab-nivolumab;
    o Voor patiënten met CR op een diagnostische CT bij responsevaluatie, is een lage dosis CT (die gewoonlijk deel uitmaakt van 18FDG-PET/CT) toegestaan ​​bij baseline
    o Voor patiënten met PR op een diagnostische CT bij de evaluatie van de respons, is een CT met een lage dosis (die gewoonlijk deel uitmaakt van 18FDG-PET/CT) toegestaan ​​als er voldoende doellaesies meetbaar zijn voor de evaluatie van de respons volgens de criteria van RECIST v1.1.
    o In geval van asymptomatische hersenmetastasen voorafgaand aan de start van eerstelijns ipilimumab-nivolumab, dient de intracerebrale tumorrespons te worden bevestigd met behulp van een MRI voorafgaand aan inclusie
    - Patiënten moeten worden opgenomen na de eerste CR/PR of de eerste bevestigde CR/PR volgens RECIST v1.1
    o Opname moet niet later plaatsvinden dan 5 weken na de eerste bevestigde CR/PR
    o In geval van SD bij eerste responsevaluatie, is bevestigde CR/PR vereist voor opname
    o gepland en bereid te stoppen met nivolumab binnen 4 (+1) weken na opname, d.w.z. eerste CR/PR of eerste bevestigde CR/PR
    o uiterlijk 9 maanden na aanvang van de behandeling met ipilimumab-nivolumab
    - Aanwezigheid van MRI-hersenen voor screening van hersenmetastasen (voorafgaand aan stopzetting van ipilimumab-nivolumab)
    - Deelnemers met eerder lokaal behandelde hersenmetastasen mogen deelnemen als ze aan de volgende criteria voldoen:
    o volledig asymptomatische hersenmetastasen bij inclusie
    o MRI van de hersenen bij baseline en voor evaluatie van de respons tijdens de behandeling
    - Getekend en gedateerd toestemmingsformulier
    E.4Principal exclusion criteria
    - Patients with SD/PD according to RECIST v1.1
    - Malignant disease other than being treated in this study. Exceptions to this exclusion include the following: malignancies that were treated curatively and have not recurred within 2 years prior to start of study treatment; completely resected basal cell and squamous cell skin cancers and any completely resected carcinoma in situ.
    - Presence of symptomatic brain metastases
     prior to first-line treatment with ipilimumab-nivolumab, or;
     when defined as new or progressive brain metastases at the time of study entry;
     brain metastases with need for steroid treatment in the last 8 weeks prior to study entry
    Note: An incidental epileptic seizure caused by a brain lesion is not considered an exclusion criterion.
    (provided that the other in- and exclusion criteria are met);
    - Presence of leptomeningeal metastases;
    - Systemic chronic steroid therapy (>10mg/day prednisone or equivalent) at inclusion or patients who need or needed any other second-line immunosuppressive therapy (e.g. infliximab, mycophenolate mofetil) for the treatment of irAEs. Note: local steroids such as topical, inhaled, nasal and ophthalmic steroids are allowed.
    - Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
    - Patiënten met SD/PD volgens RECIST v1.1
    - Kwaadaardige ziekte anders dan behandeld in deze studie. Uitzonderingen op deze uitsluiting zijn de volgende: maligniteiten die curatief werden behandeld en niet zijn teruggekomen binnen 2 jaar voorafgaand aan de start van de onderzoeksbehandeling; volledig weggesneden basaalcel- en plaveiselcelcarcinoom en elk volledig weggesneden carcinoom in situ.
    - Aanwezigheid van symptomatische hersenmetastasen
     voorafgaand aan eerstelijnsbehandeling met ipilimumab-nivolumab, of;
     wanneer gedefinieerd als nieuwe of progressieve hersenmetastasen op het moment van deelname aan het onderzoek;
     hersenmetastasen waarvoor behandeling met steroïden nodig was in de laatste 8 weken voor deelname aan het onderzoek
    Opmerking: Een incidentele epileptische aanval veroorzaakt door een hersenlaesie wordt niet beschouwd als een uitsluitingscriterium.
    (mits aan de overige in- en exclusiecriteria wordt voldaan);
    - Aanwezigheid van leptomeningeale metastasen;
    - Systemische behandeling met chronische steroïden (>10 mg/dag prednison of equivalent) bij inclusie of patiënten die een andere tweedelijns immunosuppressieve therapie nodig hebben of nodig hadden (bijv. infliximab, mycofenolaatmofetil) voor de behandeling van irAE's. Opmerking: lokale steroïden zoals lokale, inhalatie-, nasale en oftalmische steroïden zijn toegestaan.
    - Elke psychologische, familiale, sociologische of geografische aandoening die de naleving van het onderzoeksprotocol en het follow-upschema mogelijk belemmert; die voorwaarden moeten met de patiënt worden besproken vóór registratie in het onderzoek
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint of this study is response rate, defined as the rate of ongoing responses (CR and PR) according to RECIST v1.1 at 12 months after first start of first-line ipilimumab-nivolumab in patients with irresectable stage III or metastatic melanoma.
    Het primaire eindpunt van dit onderzoek is het responspercentage, gedefinieerd als het percentage aanhoudende responsen (CR en PR) volgens RECIST v1.1 op 12 maanden na de eerste start van eerstelijns ipilimumab-nivolumab bij patiënten met irresectabel stadium III of gemetastaseerd melanoom.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after last patient included
    12 maanden nadat de laatste patient is geincludeerd
    E.5.2Secondary end point(s)
    The secondary objectives of this study include the evaluation of:
    A. Patient outcomes:
    1. Ongoing response at 24 months after start of first-line treatment with ipilimumab-nivolumab
    2. Disease control (CR/PR) at different time points
    3. Duration of response (CR/PR) measured until progressive/recurrent disease
    4. Melanoma specific survival measured from start of first-line treatment with ipilimumab-nivolumab until melanoma related death
    5. Overall survival (OS) measured from start of first-line treatment with ipilimumab-nivolumab until death by any cause
    6. Impact of discontinuation treatment on (S)AEs
    7. Overall Response Rate (ORR) per RECIST v1.1 in retreated patients
    8. Need and feasibility of restarting (systemic) treatment for melanoma
    9. Disease control (CR/PR/SD/not PD) after restarting (systemic) treatment for melanoma

    B. Cost-effectiveness analysis
    1. Impact on productivity with respect to paid and unpaid work
    2. Impact on healthcare resource
    3. Impact of early discontinuation of treatment on hours of informal care

    C. Quality of Life.
    De secundaire doelstellingen van deze studie omvatten de evaluatie van:
    A. Patiëntresultaten:
    1. Aanhoudende respons 24 maanden na start van eerstelijnsbehandeling met ipilimumab-nivolumab
    2. Ziektebestrijding (CR/PR) op verschillende tijdstippen
    3. Duur van respons (CR/PR) gemeten tot progressieve/recidiverende ziekte
    4. Melanoomspecifieke overleving gemeten vanaf de start van de eerstelijnsbehandeling met ipilimumab-nivolumab tot aan melanoomgerelateerd overlijden
    5. Totale overleving (OS) gemeten vanaf de start van de eerstelijnsbehandeling met ipilimumab-nivolumab tot overlijden door welke oorzaak dan ook
    6. Impact van stopzetting van de behandeling op (S)AE's
    7. Totaal responspercentage (ORR) volgens RECIST v1.1 bij opnieuw behandelde patiënten
    8. Noodzaak en haalbaarheid van herstart (systemische) behandeling voor melanoom
    9. Ziektebestrijding (CR/PR/SD/niet PD) na herstart (systemische) behandeling voor melanoom

    B. Kosteneffectiviteitsanalyse
    1. Impact op productiviteit met betrekking tot betaald en onbetaald werk
    2. Impact op de middelen voor de gezondheidszorg
    3. Impact van vroegtijdige stopzetting van de behandeling op uren mantelzorg

    C. Kwaliteit van leven.
    E.5.2.1Timepoint(s) of evaluation of this end point
    60 months after last patient has started treatment
    60 maanden nadat de laatste patient startte met behandeling
    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 Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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 concerned14
    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
    After last patient inclusion completed follow up period (i.e. a maximum of 5 years)
    Nadat laatste patient inclusie de follow up periode (max 5 jaar) heeft volbracht
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years10
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 70
    F.1.3Elderly (>=65 years) No
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    Geen
    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 Decision2022-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-31
    P. End of Trial
    P.End of Trial StatusOngoing
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