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    Summary
    EudraCT Number:2009-018077-31
    Sponsor's Protocol Code Number:012010
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-20
    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 number2009-018077-31
    A.3Full title of the trial
    A PHASE I/II DOSE SCHEDULE FINDING STUDY
    FOR CH14.18/CHO CONTINUOUS INFUSION COMBINED WITH SUBCUTANEOUS ALDESLEUKIN (IL-2)
    IN PATIENTS WITH PRIMARY REFRACTORY OR RELAPSING NEUROBLASTOMA
    Badanie fazy I/II dotyczące schematu dawkowania przeciwciał Anty-GD2 (CH14.18/CHO) we wlewie ciągłym stosowanych łącznie lub bez Interleukiny 2 (IL-2, Aldesleukina) podawanej podskórnie u pacjentów z Neuroblastoma pierwotnie opornym na terapię lub ze wznową choroby
    - Badanie Grupy SIOPEN
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long term continuous infusion ch14.18/CHO plus s.c. aldesleukin (IL-2)
    Długotrwały wlew ciągły ch14.18/CHO z lub bez s.c. aldesleukiny (IL-2) – badanie randomizowane
    A.3.2Name or abbreviated title of the trial where available
    Long term continuous infusion ch14.18/CHO
    Długotrwały wlew ciągły ch14.18/CHO z lub bez s.c. aldesleukiny (IL-2) – badanie randomizowane
    A.4.1Sponsor's protocol code number012010
    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 SponsorJagiellonian University Medical College
    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 supportJagiellonian University Medical College in Krakow
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKlinika Onkologii i Hematologii Dziecięcej
    B.5.2Functional name of contact pointprof. Walentyna Balwierz
    B.5.3 Address:
    B.5.3.1Street Addressul. Wielicka 265
    B.5.3.2Town/ cityKrakow
    B.5.3.3Post code30-663
    B.5.3.4CountryPoland
    B.5.4Telephone number+48126580261
    B.5.5Fax number+48126581081
    B.5.6E-mailwalentyna.balwierz@uj.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 namech14.18/CHO
    D.3.2Product code ch14.18/CHO
    D.3.4Pharmaceutical form 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 INNch14.18/CHO
    D.3.9.3Other descriptive namech14.18/CHO
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.6
    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 Proleukin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameAldesleukin
    D.3.4Pharmaceutical form Powder and solvent 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 INNinterleukin-2
    D.3.9.1CAS number 110942-02-4
    D.3.9.2Current sponsor codePL 00101/0936
    D.3.9.3Other descriptive nameALDESLEUKIN
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18000000
    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: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Kwas 13-cis retinowy
    D.2.1.1.2Name of the Marketing Authorisation holderSunFarm
    D.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameKwas 13-cis retinowy
    D.3.4Pharmaceutical form Capsule, soft
    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 INNISOTRETINOIN
    D.3.9.3Other descriptive nameKwas 13-cis retinowy
    D.3.9.4EV Substance CodeSUB08341MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10 mg i 20 mg
    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
    High-risk neuroblastoma patients having received at least one previous high dose treatment followed by stem cell rescue after conventional therapy fulfilling one of the following criteria:
    • Primary refractory patients with stage 4 disease with at least two lines of treatment prior to HDT/SCT, causing a delay from diagnosis to SCT of over 9 months
    • Relapse after primary stage 4 disease
    • Disseminated relapse after primary localized neuroblastoma
    Pacjenci z NBL wysokiego ryzyka po co najmniej jednej terapii wysokodawkowaną z SCT po konwencjonalnej terapii, spełniający poniższe kryteria:
    1.choroba pierwotnie oporna na leczenie w 4. stopniu zaawansowania, u których przed HDT/SCT podano minimum dwie linie leczenia co spowodowało, że czas pomiędzy diagnozą a SCT był dłuższy niż 9 miesięcy
    2.wznowa choroby u pacjentów wstępnie w 4. stopniu zaawansowania
    3.rozsiana wznowa choroby u pacjentów wstępnie ze zlokalizowaną postacią NBL

    E.1.1.1Medical condition in easily understood language
    Neuroblastoma
    Neuroblastoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To find an improved treatment schedule which reduces the pain-toxicity profile of ch14.18/CHO whilst maintaining immunomodulatory efficacy in patients (1-21 years old) with primary refractory (≥ 2 lines of conventional treatment) or relapsed neuroblastoma through prolonged continuous infusion in combination with s.c aldesleukin (IL-2).
    V3: Based on the IL-2 toxicity profile and recent data from the HRNBL1 SIOPEN trial, the study committee decided to evaluate the role of IL-2 for EFS (event free survival) in the LTI setting by randomizing the current standard arm against an ch14.18/CHO only treatment arm (additional randomised question = ARAQ). The use of isotretinoin remains unchanged in both treatment arms
    Celem głównym badania jest ustalenie schematu dawkowania leku, który zredukuje toksyczności związane z bólem podczas infuzji przeciwciał ch14.18/CHO przy zachowaniu efektywności działania immunomodulującego u pacjentów (1-21 lat) zarówno z neuroblastoma pierwotnie oporną na leczenie (≥2 linie konwencjonalnego leczenia), jak i ze wznową choroby poprzez zastosowanie długotrwałej ciągłej infuzji (LTI) łącznie z aldesleukiną s.c (IL-2).
    Protokół Wersja 3 (Międzynarodowa poprawka 2):
    W oparciu o profil toksyczności IL-2 i ostatnich danych z badania HR-NBL-1 SIOPEN, Komitet Naukowy Badania postanowił ocenić wpływ stosowania IL-2 na EFS (przeżycie wolne od niekorzystnych wydarzeń) w protokole LTI poprzez randomizowany wybór obecnego standardowego ramienia lub ramienia z zastosowaniem tylko ch14.18/CHO (dodatkowe pytanie randomizowane=ARAQ). Izotretinoina stosowana jest jak dotychczas w obu ramionach leczenia.
    E.2.2Secondary objectives of the trial
    To assess pain intensity and relief by appropriate medication with a validated self- report tool.
    To validate, during the first course, the correlation between activated NK cells and ch14.18/CHO level with ADCC by using MNC and serum from patients on day 15.
    To determine systemic immune modulation/response resulting from the combined treatment of ch14.18/CHO and s.c. aldesleukin (IL-2) by repeated analysis of NK-cell activation, soluble IL-2 receptor, ADCC, CDC and anti-idiotype activation (HAMA and HACA).
    To achieve an increase in absolute lymphocyte counts and absolute NK cell numbers after the respective cycles as a measurement of response to s.c. aldesleukin (IL-2).
    To determine the pharmacokinetics of ch14.18/CHO.
    To evaluate anti-tumour responses resulting from this treatment regimen through clinical assessments in patients with measurable disease.

    • Ocena intensywności bólu i jego redukcji po leczeniu na podstawie oceny z zastosowaniem walidowanych skal oceny bólu.
    •Ocena w 1. cyklu korelacji między aktywowanymi kom. NK i poziomem ch14.18/CHO a ADCC w surowicy i MNC w 15. dniu cyklu.
    •Ocena ustrojowej modulacji/odpowiedzi immunologicznej w wyniku leczenia ch14.18/CHO z lub bez s.c. aldesleukiny (IL-2) przez analizy aktywacji kom. NK, rozpuszczalnego receptora IL-2, ADCC, CDC i odpowiedzi anty-idiotypowej (HAMA i HACA).
    •Wzrost bezwzględnej liczby limfocytów i kom. NK po każdym cyklu jako ocena odpowiedzi na s.c. aldesleukinę (IL-2) u pacjentów w ramieniu standardowym
    •Ocena farmakokinetyki ch14.18/CHO.
    •Ocena odpowiedzi wynikającej ze schematu leczenia przez kliniczną ocenę pacjentów z chorobą mierzalną.
    •Ocena ustrojowej modulacji/odpowiedzi immunologicznej przez analizę pełnej krwi (Greifswald, Regensburg, Tübingen, Berlin)
    •Ocena polimorfizmu receptora Fc i niedopasowania KIR/KIR-ligand (wszystkie ośrodki)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Key inclusion criteria
    Patients with neuroblastoma >1 and ≤ 21 years of age (age limit for trial cohorts only), having received at least one previous high dose treatment followed by stem cell rescue after conventional therapy to reduce tumour burden fulfilling one of the following criteria:
    • Primary refractory patients with stage 4 disease with at least two lines of treatment prior to HDT/ASCT, causing a delay from diagnosis to ASCT of over 9 months. (For example, patients who are on the current high-risk SIOPEN trial (HR-NBL-1/SIOPEN) and have completed high-dose treatment but are ineligible for the R4 randomization due to major delays for toxicity).
    • Relapse after primary stage 4 disease.
    • Disseminated relapsed neuroblastoma having received ASCT.
    Patients must have a life expectancy of at least 12 weeks.
    Pacjenci z neuroblastoma >1 i ≤21 lat (limit wiekowy tylko dla grup badanych), z rozpoznanym neuroblastoma zgodnie z kryteriami INSS, którzy otrzymali co najmniej jeden cykl chemioterapii wysokodawkowej z przeszczepieniem macierzystych komórek krwiotwórczych po wcześniejszej chemioterapii konwencjonalnej w celu redukcji masy guza, którzy wypełnili co najmniej jedno z poniższych kryteriów:
    • Pacjenci z 4. stopniem zaawansowania neuroblastoma:
     u których w trakcie leczenia zgodnie z obowiązującym protokołem Grupy SIOPEN dla neuroblastoma wysokiego ryzyka (HR-NBL-1/SIOPEN) mieli stwierdzoną chorobę pierwotnie oporną i u których zastosowano więcej niż dwie linie leczenia indukcyjnego lub którzy nie zostali zakwalifikowani do randomizacji R4 z powodu zbyt dużych opóźnień po zakończeniu leczenia z zastosowaniem chemioterapii wysokodawkowej
    albo
     u których zastosowano inne niż w protokole HR-NBL-1/SIOPEN standardowe leczenie pierwszej linii dla grupy wysokiego ryzyka, składające się z intensywnej chemioterapii indukcyjnej, a następnie megachemioterapią z przeszczepieniem komórek macierzystych
    • Leczona i odpowiadająca na leczenie wznowa neuroblastoma po chorobie w 4. stopniu zaawansowania w czasie pierwszej diagnozy, bez objawów progresji przy włączeniu do badania
    • Leczona i odpowiadająca na leczenie rozsiana wznowa neuroblastoma po zastosowaniu autologicznego przeszczepienia komórek krwiotwórczych (ASCT), bez objawów progresji przy włączeniu do badania
    • Oczekiwana długość przeżycia pacjenta co najmniej 12 tygodni.
    E.4Principal exclusion criteria
    Progressive disease and previous treatment with ch14.18/SP2/0 and/or ch14.18/CHO

    Progresja choroby i wcześniejsze leczenie z zastosowaniem ch14.18/SP2/0 i/lub ch14.18/CHO
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is event free survival calculated from the date of randomisation. The following will be considered as events:
    - disease progression or relapse,
    - death from any cause
    - second neoplasm
    Pierwszorzędowym punktem końcowym jest przeżycie wolne od niekorzystnych wydarzeń oceniane od daty randomizacji.
    Jako wydarzenie będą traktowane:
    1.wznowa lub progresja choroby
    2. zgon z jakiejkolwiek przyczyny
    3. wtórne nowotwory
    E.5.1.1Timepoint(s) of evaluation of this end point
    The final analysis will be performed 1 year after the closure of the randomisation. All analyses will be intention to treat, i.e. with all patients analysed in the arm to which they were randomised
    Końcowa analiza wykonana będzie po jednym roku od zakończenia randomizacji. Wszystkie analizy będą wykonane zgodnie z intencją leczenia (ITT) tj: wszyscy pacjenci analizowani będą w grupie do której zostali randomizowani.
    E.5.2Secondary end point(s)
    Biomarkers
    Response criteria
    Immunological assessments
    Biomarkery
    Kryteria odpowiedzi
    Ocena immunologiczna
    E.5.2.1Timepoint(s) of evaluation of this end point
    Descriptive analysis of serum biomarkers at different time points during treatment will be performed.
    Response analysis - All patients who complete the first cycle will be considered evaluable for anti-tumour response.

    Wykonana będzie analiza opisowa biomarkerów w surowicy w różnych punktach czasowych podczas całego okresu leczenia.
    Ocena odpowiedzi – u wszystkich pacjentów którzy ukończą pierwszy cykl rozważone będzie wykonanie oceny odpowiedzi nowotworu na leczenie.
    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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    dose finding study
    Badanie dotyczące doboru dawki leku
    E.7.2Therapeutic exploratory (Phase II) No
    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 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.8.2.4Number 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    France
    Germany
    Hong Kong
    Israel
    Italy
    Poland
    Spain
    United Kingdom
    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
    The end of trial is defined as the date of the last visit of the last patient undergoing the trial. This will allow sufficient time for the completion of protocol procedures, data collection and data input.
    Zakończenie badania klinicznego jest zdefiniowane jako data ostatniej wizyty ostatniego pacjenta włączonego do badania. Zapewni to odpowiednią ilość czasu na zakończenie procedur związanych z badaniem, zebraniem i uzupełnieniem danych.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 284
    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) Yes
    F.1.1.4.1Number of subjects for this age range: 284
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 284
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 140
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 284
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Patients under 18 years old
    Pacjenci poniżej 18 r.ż.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 274
    F.4.2.2In the whole clinical trial 284
    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
    Nie dotyczy
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-04-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
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