Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-004257-24
    Sponsor's Protocol Code Number:PROSPETMR2021
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-02-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2021-004257-24
    A.3Full title of the trial
    Multicentre Evaluation of Clinical Applications of Innovative PET/MRI with a 68Ga-PSMA-11 Radiotracer when Planning a Personalised Therapy in Prostate Cancer Patients
    Wieloośrodkowa ocena przydatności klinicznej innowacyjnego badania PET/MR z wykorzystaniem radioznacznika 68Ga-PSMA-11 w planowaniu terapii personalizowanej u chorych na raka gruczołu krokowego
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicentre, Phase 3 Trial to Determine Diagnostic Value of 68Ga-PSMA-11 (in PET/CT and PET/MRI) in Intermediate and High-Risk Prostate Cancer Patients before Introduction of Radical Treatment and in Patients Diagnosed with Biochemical Failure Following Radical Treatment
    Wieloośrodkowe badanie fazy 3 mające na celu wykazanie wartości diagnostycznej 68Ga-PSMA-11 (w PET/CT i PET/MR) u chorych z rakiem gruczołu krokowego pośredniego i wysokiego ryzyka przed wdrożeniem leczenia radykalnego oraz u chorych z rozpoznaniem wznowy biochemicznej po przebytym leczeniu radykalnym
    A.3.2Name or abbreviated title of the trial where available
    PROSPETMR2021
    A.4.1Sponsor's protocol code numberPROSPETMR2021
    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 SponsorUniwersytet Medyczny w Białymstoku
    B.1.3.4CountryPoland
    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 supportAgencja Badań Medycznych, 2020/ABM/01/00074
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOśrodek Wsparcia Badań Klinicznych, Uniwersytet Medyczny w Białymstoku
    B.5.2Functional name of contact pointClinical Trial Information Point
    B.5.3 Address:
    B.5.3.1Street AddressUl. Jana Kilińskiego 1
    B.5.3.2Town/ cityBiałystok
    B.5.3.3Post code15-089
    B.5.3.4CountryPoland
    B.5.4Telephone number004885 686 51 22
    B.5.6E-mailowbk@umb.edu.pl
    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 name68Ga-PSMA-11
    D.3.4Pharmaceutical form Solution for injection
    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 INN68Ga-PSMA-HBED-CC
    D.3.9.2Current sponsor code68Ga-PSMA-11
    D.3.9.3Other descriptive name68Ga-PSMA-HBED-CC
    D.3.9.4EV Substance CodeSUB192221
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/kg megabecquerel(s)/kilogram
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1.8 to 2.2
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGALLIUM (68GA) CHLORIDE
    D.3.9.2Current sponsor code68Ga
    D.3.9.3Other descriptive nameGALLIUM (68GA) CHLORIDE
    D.3.9.4EV Substance CodeSUB170788
    D.3.10 Strength
    D.3.10.1Concentration unit MBq megabecquerel(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPSMA-11
    D.3.9.1CAS number 1366302-52-4
    D.3.9.2Current sponsor codeinhibitor PSMA
    D.3.9.3Other descriptive namePSMA-11
    D.3.9.4EV Substance CodeSUB208559
    D.3.10 Strength
    D.3.10.1Concentration unit mCi/µg millicurie(s)/microgram
    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 Yes
    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
    Intermediate and high-risk prostate cancer before introduction of radical treatment and in patients diagnosed with biochemical failure following radical treatment
    Rak gruczołu krokowego pośredniego i wysokiego ryzyka przed wdrożeniem leczenia radykalnego oraz u chorych z rozpoznaniem wznowy biochemicznej po przebytym leczeniu radykalnym
    E.1.1.1Medical condition in easily understood language
    Intermediate and high-risk prostate cancer
    Rak gruczołu krokowego pośredniego i wysokiego ryzyka
    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 10060862
    E.1.2Term Prostate cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determination of diagnostic applications of 68Ga-PSMA-11 (in PET/CT and PET/MRI) for staging of prostate cancer and precise location of neoplastic lesions with personalized dosimetry.
    Wykazanie wartości diagnostycznej 68Ga-PSMA-11 (w PET/CT i PET/MR) w ocenie stadium zaawansowania RGK i precyzyjnej lokalizacji zmian nowotworowych spersonalizowanej dozymetrii
    E.2.2Secondary objectives of the trial
    - To compare incidence of treatment plan alterations following standard diagnostics 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
    - To compare incidence of relapse location following standard diagnostics, 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI (Group 2 only)
    - To determine concentration of Prostate Specific Antigen (PSA) justifying 68Ga-PSMA-11 PET/MRI (Group 2 only)
    - To assess and compare safety of 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
    - To assess and compare absorbed radiation dose during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
    - To assess pharmacoeconomic data (compare costs of procedures planned after visit 1 and those actually performed after the investigated diagnostics were carried out)
    - Porównanie częstości zmiany ścieżki terapeutycznej po badaniu standardowymi metodami, 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR
    - Porównanie częstości wykrycia umiejscowienia wznowy po badaniu standardowymi metodami, 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR (tylko dla drugiej grupy)
    - Ustalenie stężenia swoistego antygenu sterczowego (PSA, Prostate Specific Antigen ), dla którego zasadne jest wykonanie badania 68Ga-PSMA-11 PET/MR (tylko dla drugiej grupy)
    - Ocena i porównanie bezpieczeństwa badania 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR
    - Ocena i porównanie dawki pochłoniętego promieniowania podczas badania 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR
    - Ocena danych farmakoekonomicznych (porównanie kosztów procedur, które planowane były do wykonania po pierwszej wizycie, i tych, które w rzeczywistości zostały wykonane po przeprowadzeniu ocenianych badań)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients meeting all of the following criteria will be eligible for the study:
    - Age ≥18 years
    - Signing informed consent to participate in the study
    Group 1.
    Patients with a diagnosis or high probability of intermediate and high risk CRC according to ISUP, in whom radical treatment is planned to be implemented
    - Prostate adenocarcinoma confirmed by biopsy and histopathological examination
    - Results indicative of intermediate (Gleason score 7 or cT2b OR PSA 10-20 ng/ml) or high (Gleason score > 7 OR cT2c or PSA > 20 ng/ml) risk ISUP RGK
    - Creatinine value to safely perform PET/MR with contrast medium: creatinine less than or equal to 1.5x upper limit of normal, creatinine clearance >60 mL/min
    - Performed mpMR study of the pelvis/prostate, no more than 90 days prior to inclusion in the project
    - Status after prostate BAC
    Group 2.
    - Age ≥18 years
    - Signing informed consent to participate in the study
    Patients with CRC after radical treatment, with biochemical recurrence according to EAU criteria, in whom further treatment is planned and the result of the imaging/molecular study may change the therapeutic decision:
    - Prostate adenocarcinoma confirmed by histopathology
    - After radical treatment
    For patients after radical prostatectomy: with at least two PSA measurements ≥0.2 ng/ml not earlier than 6 weeks after radical prostatectomy OR PSA≥0.1 with PSAdt (PSA doubling time) <3 months. PSA in at least two consecutive tests in the last 6 months prior to eligibility (last determination within 6 weeks prior to eligibility, does not need to be done on the day of the visit)
    Or
    - For patients after radical radiotherapy: biochemical recurrence defined as nadir PSA + 2 ng/ml (we consider the lowest PSA concentration during ADT + 2ng/ml)
    - Radical treatment included the inclusion of hormone therapy:
    1. three consecutive PSA increases, of which at least two measurements with an increase of at least 50% above the nadir level
    2. current PSA > 2 ng/mL
    Do badania zakwalifikowani będą pacjenci spełniający wszystkie poniższe kryteria:
    - Wiek ≥18 lat
    - Podpisanie świadomej zgody na udział w badaniu
    Grupa 1.
    Chorzy z rozpoznaniem lub dużym prawdopodobieństwem RGK średniego i wysokiego ryzyka wg ISUP, u których planowane jest wdrożenie leczenia radykalnego
    - Gruczolakorak prostaty potwierdzony biopsją i badaniem histopatologicznym
    - Wyniki wskazujące na RGK średniego (Gleason score 7 lub cT2b LUB PSA 10-20 ng/ml) lub wysokiego (Gleason score > 7 LUB cT2c lub PSA > 20 ng/ml) ryzyka wg ISUP
    - Wartość kreatyniny pozwalająca na bezpieczne wykonanie badania PET/MR ze środkiem kontrastowym: kreatynina mniejsza lub równa 1,5x górnej granicy normy, klirens kreatyniny >60 mL/min
    - Przeprowadzone badanie mpMR miednicy/prostaty, nie wcześniej niż 90 dni przed włączeniem do projektu
    - stan po wykonaniu BAC prostaty
    Grupa 2.
    - Wiek ≥18 lat
    - Podpisanie świadomej zgody na udział w badaniu
    Chorzy na RGK po leczeniu radykalnym, przy wznowie biochemicznej wg kryteriów EAU, u których planuje się dalsze leczenie, a wynik badania obrazowego/molekularnego może wpłynąć na zmianę decyzji terapeutycznej:
    - Gruczolakorak prostaty potwierdzony badaniem histopatologicznym
    - Po leczeniu radykalnym
    W przypadku chorych po radykalnej prostatektomii: z co najmniej dwukrotnym pomiarem PSA ≥0,2 ng/ml nie wcześniej niż po 6 tygodniach po radykalnej prostatektomii LUB PSA≥0,1 przy PSAdt (PSA doubling time) <3 mies. PSA w co najmniej dwóch kolejnych badaniach w ciągu ostatnich 6 miesięcy przed kwalifikacją (ostatnie oznaczenie w ciągu 6 tygodni przed kwalifikacją, nie trzeba robić w dzień wizyty)
    Lub
    - W przypadku chorych po radykalnej radioterapii: wznową biochemiczną definiowaną jako nadir PSA + 2 ng/ml (bierzemy pod uwagę najniższe stężenie PSA podczas ADT + 2ng/ml)
    - Leczenie radykalne obejmowało włączenie hormonoterapii:
    1. Trzy kolejne wzrosty stężenia PSA, z których co najmniej dwa pomiary ze wzrostem co najmniej 50% powyżej poziomu nadir
    2. Aktualne PSA > 2 ng/mL
    E.4Principal exclusion criteria
    A person who is found to have at least one of the following will be excluded from the study
    listed below:
    - No informed consent to participate in the study
    - Age < 18 years
    - Presence of metallic foreign bodies/implants/prostheses/stimulators etc. inside the body, the possession of which is a contraindication to the 3T MR examination
    - Claustrophobia
    - Patient size preventing PET/MR examination due to the diameter of the gantry. In doubtful cases, consultation with the research centre Bialystok or Bydgoszcz respectively is advisable
    - Known contraindications to the use of radiopharmaceuticals or excipients (e.g. renal failure and allergy to the components of the preparation)
    - Hormone therapy (applies to group 1 only)
    - Treatment for a malignant neoplasm unrelated to the prostate gland (skin cancer) within the last 5 years.
    - Participation in another clinical trial
    Z badania zostanie wyłączona osoba, u której stwierdzono choć jedno z
    wymienionych poniżej:
    - Brak świadomej zgody na udział w badaniu
    - Wiek < 18 lat
    - Obecność wewnątrz organizmu metalicznych ciał obcych/implantów/protez/ stymulatorów itp., których posiadanie jest przeciwwskazaniem do wykonania badania MR 3T
    - Klaustrofobia
    - Rozmiary pacjenta uniemożliwiające przeprowadzenie badania PET/MR ze względu na średnicę gantry. W przypadkach wątpliwych wskazana konsultacja z ośrodkiem badawczym odpowiednio Białystok lub Bydgoszcz
    -Znane przeciwwskazania do stosowania produktów radiofarmaceutycznych lub substancji pomocniczych (np. niewydolność nerek oraz alergia na składniki preparatu)
    - Hormonoterapia (dotyczy tylko grupy 1)
    - Leczenie z powodu nowotworu złośliwego niezwiązanego z gruczołem krokowym (rak skóry) w ciągu ostatnich 5 lat.
    - Uczestniczenie w innym badaniu klinicznym
    E.5 End points
    E.5.1Primary end point(s)
    - Percentage of patients for whom, following 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI and precise location of neoplastic lesions , prostate cancer staging was changed according to ISUP (International Society of Urological Pathology) and TNM classification
    - Percentage of patients, in whom, with 68Ga-PSMA PET/MRI and 68Ga-PSMA location of prostate cancer relapse was detected (detection rate) – Study Group 2 only
    - Odsetek pacjentów, u których po badaniach 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR nastąpiła zmiana stagingu RGK wg Międzynarodowego Towarzystwa Uro-Patologii (ISUP, International Society of Urological Pathology) i klasyfikacji TNM, i precyzyjnej lokalizacji zmian nowotworowych
    - Odsetek pacjentów, u których za pomocą 68Ga-PSMA PET/MR i 68Ga-PSMA wykryto lokalizację wznowy RGK (detection rate) – tylko w przypadku drugiej grupy badanej
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Percentage of patients for whom, following 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI and precise location of neoplastic lesions , prostate cancer staging was changed according to ISUP (International Society of Urological Pathology) and TNM classification
    - Percentage of patients, in whom, with 68Ga-PSMA PET/MRI and 68Ga-PSMA location of prostate cancer relapse was detected (detection rate) – Study Group 2 only
    - Odsetek pacjentów, u których po badaniach 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR nastąpiła zmiana stagingu RGK wg Międzynarodowego Towarzystwa Uro-Patologii (ISUP, International Society of Urological Pathology) i klasyfikacji TNM, i precyzyjnej lokalizacji zmian nowotworowych
    - Odsetek pacjentów, u których za pomocą 68Ga-PSMA PET/MR i 68Ga-PSMA wykryto lokalizację wznowy RGK (detection rate) – tylko w przypadku drugiej grupy badanej
    E.5.2Secondary end point(s)
    - Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts an alteration of the treatment plan
    - Percentage of patients, in whom 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI prompts finding of the relapse location (Group 2 only)
    - PSA levels, with which the relapse location was found with 68Ga-PSMA-11 PET/MRI (Group 2 only)
    Number and type of serious adverse effects reported during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
    - Mean absorbed radiation dose during 68Ga-PSMA-11 PET/CT and 68Ga-PSMA-11 PET/MRI
    - Pharmacoeconomic data (cost of procedures planned to be performed after visit 1 and those actually performed after the investigated diagnostics were carried out)
    - Odsetek pacjentów, u których wykonanie badania 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR doprowadzi do zmiany ścieżki terapeutycznej
    - Odsetek pacjentów, u których wykonanie badania 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR doprowadzi do wykrycia umiejscowienia wznowy (tylko dla drugiej grupy)
    - Stężenie PSA, przy którym za pomocą badania 68Ga-PSMA-11 PET/MR wykryto umiejscowienie wznowy (tylko dla drugiej grupy)
    Liczba i rodzaj poważnych zdarzeń niepożądanych podczas badania 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR
    - Średnia dawka pochłoniętego promieniowania podczas badania 68Ga-PSMA-11 PET/CT i 68Ga-PSMA-11 PET/MR
    - Dane farmakoekonomiczne (koszt procedur, które planowane były do wykonania po pierwszej wizycie, i tych, które w rzeczywistości zostały wykonane po przeprowadzeniu ocenianych badań)

    E.5.2.1Timepoint(s) of evaluation of this end point
    It is planned to determine PSA concentration during the visit V0, V2 and V3. The total amount of blood during one blood collection - 6.8 ml.
    Planowane jest wykonanie oznaczenia stężenie PSA podczas wizyty W0,W 2 i W3 Łączna ilość krwi w trakcie jednego pobrania - 6,8 ml.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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) Yes
    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 No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    PET/CT i PET/MR
    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 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
    LPLV
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    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: 183
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 183
    F.2 Gender
    F.2.1Female No
    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 state366
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 366
    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
    BRAK
    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 Decision2022-09-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-01-20
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 10 02:46:49 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA