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    Summary
    EudraCT Number:2013-003303-18
    Sponsor's Protocol Code Number:rl.01.2013
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-01-24
    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 number2013-003303-18
    A.3Full title of the trial
    Clinical phase IV study assessing the efficacy and safety of the medicinal product Groprinosin in treatment of recurrent airway inflammation in children with impaired cellular immunity and diagnosed or undiagnosed allergic disease
    Badanie kliniczne fazy IV oceniające skuteczność i bezpieczeństwo produktu leczniczego Groprinosin w leczeniu nawracająch stanów zapalnych dróg oddechowych u dzieci z upośledzeniem odporności komórkowej i rozpoznaną lub nie chorobą alergiczną
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical phase IV study assessing the efficacy and safety of the medicinal product Groprinosin in treatment of recurrent airway inflammation in children with impaired cellular immunity and diagnosed or undiagnosed allergic disease
    Badanie kliniczne fazy IV oceniające skuteczność i bezpieczeństwo produktu leczniczego Groprinosin w leczeniu nawracająch stanów zapalnych dróg oddechowych u dzieci z upośledzeniem odporności komórkowej i rozpoznaną lub nie chorobą alergiczną
    A.4.1Sponsor's protocol code numberrl.01.2013
    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 SponsorGedeon Richter Polska Sp. z o. o.
    B.1.3.4CountryPoland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGedeon Richter Polska Sp. z o. o.
    B.4.2CountryPoland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDr n. med. Paweł Rakowski
    B.5.2Functional name of contact pointDział Medyczny (Medical Department)
    B.5.3 Address:
    B.5.3.1Street AddressGedeon Richter Polska Sp. z o. o. ,ul. Ks. J. Poniatowskiego 5
    B.5.3.2Town/ cityGrodzisk Mazowiecki
    B.5.3.3Post code05-825
    B.5.3.4CountryPoland
    B.5.4Telephone number48227559625
    B.5.5Fax number48227555566
    B.5.6E-mailprakowski@grodzisk.rgnet.org
    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 Groprinosin 50 mg/ml, syrup
    D.2.1.1.2Name of the Marketing Authorisation holderGedeon Richter Polska Sp. z o. o.
    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.3.4Pharmaceutical form Syrup
    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 INNINOSINE ACEDOBEN DIMEPRANOL
    D.3.9.1CAS number 36703-88-5
    D.3.9.4EV Substance CodeSUB14214MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    Recurrent airway inflammation in children with impaired cellular immunity.
    Nawracające stany zapalne dróg oddechowych u dzieci z upośledzeniem odporności komórkowej.
    E.1.1.1Medical condition in easily understood language
    Recurrent airway inflammation in children with immunodeficiency.
    Nawracające stany zapalne dróg oddechowych u dzieci z niedoborem odporności.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    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
    Evaluation of short-and long-term safety and efficacy of the medicinal product Groprinosin 50 mg / ml syrup in the treatment of recurrent airway inflammation in children with impaired cellular immunity and diagnosed or undiagnosed allergic disease.
    Ocena krótko-i długoterminowa skuteczności i bezpieczeństwa produktu leczniczego Groprinosin 50 mg/ml, syrop w leczeniu nawracających stanów zapalnych dróg oddechowych u dzieci z upośledzeniem odporności komórkowej i rozpoznaną chorobą alergiczną lub jej brakiem.
    E.2.2Secondary objectives of the trial
    Not applicable
    Nie dotyczy
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1 Age> 24 months to <12 years at inclusion in the study.
    2 Consent of parent / legal representative of the child to participate in the study, confirmed by signing the Informed Consent Form for Parent / legal representative of the patient before the first study procedures and after obtaining explanations concerning the design and purpose of the study;
    3 Frequent respiratory infection (not less than 6 cases per year), of chronic (> 10 days), difficult to treat (the slow process of recovery).
    4 Patients with laboratory-confirmed impaired cellular immunity (reduction in absolute number and / or interest of T cells and / or impairment of the function) with a possible simultaneous slight decrease in the level of fractions of IgG, IgM, IgA.
    1. Wiek > 24 miesiąca życia do < 12 lat w dniu włączenia do badania.
    2. Wyrażenie zgody rodzica/ przedstawiciela ustawowego na udział dziecka w badaniu, potwierdzone przez podpisanie Formularza Świadomej Zgody Rodzica/ Przedstawiciela ustawowego pacjenta przed wykonaniem pierwszych procedur badawczych i po uzyskaniu wyjaśnień dotyczących formy i celu tego badania;
    3. Częste stany zapalne układu oddechowego (nie mniej niż 6 zachorowań na rok), o przewlekłym przebiegu (> 10 dni), trudne do leczenia (powolny proces zdrowienia).
    4. Pacjenci, u których potwierdzono laboratoryjnie upośledzenie odporności komórkowej (obniżenie liczby bezwzględnej i/lub odsetkowej limfocytów T oraz/lub upośledzenie ich funkcji) z możliwym jednoczesnym nieznacznym obniżeniem poziomu frakcji immunoglobulin IgG, IgM, IgA.
    E.4Principal exclusion criteria
    1 Renal failure , determined on the basis of clinical evaluation and laboratory tests .
    2 Gout , kidney stones and increased uric acid in the blood indicated on the basis of medical history and laboratory tests .
    3 Hypersensitivity to the active substance or any Groprinosin drug excipients .
    4 Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase - isomaltase insufficiency.
    5 Administration of xanthine oxidase inhibitors , diuretics or azidothymidine .
    6 Currently recognized infectious or contagious disease or inflammation of different etiologies and the need for antibiotic treatment.
    7 The use of immunostimulatory drugs (including nonspecific vaccines ) or immunosuppressants within 6 months or corticosteroids- systemic, inhaled and used externally within 1 month prior to inclusion in the study.
    8 The use of specific immunotherapy and vaccinations within 4 weeks prior to enrollment .
    9 The use of antibiotic therapy within 1 month prior to inclusion in the study.
    10 Another reason , which in the opinion of the investigator disqualify a patient from the study
    1. Niewydolność nerek, oznaczona na podstawie oceny klinicznej i testów laboratoryjnych.
    2. Dna moczanowa, kamica nerkowa i zwiększone stężenie kwasu moczowego we krwi oznaczone na podstawie wywiadu medycznego i testów laboratoryjnych.
    3. Nadwrażliwość na substancję czynną leku Groprinosin lub jakąkolwiek substancję pomocniczą leku.
    4. Pacjenci z rzadkimi dziedzicznymi zaburzeniami związanymi z nietolerancją fruktozy, zespołem złego wchłaniania glukozy-galaktozy lub niedoborem sacharazy- izomaltazy.
    5. Przyjmowanie inhibitorów oksydazy ksantynowej, diuretyków lub azydotymidyny.
    6. Rozpoznana aktualnie choroba zakaźna infekcyjna lub stan zapalny o innej etiologii i potrzeba zastosowania antybiotykoterapii.
    7. Stosowanie leków immunostymulujących (w tym szczepionek nieswoistych) lub immunosupresyjnych w okresie 6 miesięcy lub kortykosteroidów stosowanych systemowo, wziewnie oraz zewnętrznie w okresie 1 miesiąca poprzedzającego włączenie do badania.
    8. Stosowanie immunoterapii swoistej oraz szczepień ochronnych w okresie 4 tygodni poprzedzających włączenie do badania.
    9. Stosowanie antybiotykoterapii w ciągu 1 miesiąca poprzedzającego włączenie do badania.
    10. Inny powód, który w ocenie Badacza dyskwalifikuje pacjenta z udziału w badaniu
    E.5 End points
    E.5.1Primary end point(s)
    Evaluation of the short-term efficacy :
    • Number of episodes of respiratory infection- comparison of period 4 months before and 4 months after the start of the treatment period 1
    • The average duration of episodes of respiratory tract infection - (number of sickness days ) comparison of period 4 months before and 4 months after the start of the treatment period 1
    • Change in the severity of the infection, according to the scale of clinical symptoms - a comparison of the period 4 months before and 4 months after the start of the treatment period 1
    Evaluation of the long-term efficacy :
    • The number of episodes of respiratory tract infection - comparison of period 12 months before and 12 months of treatment period and follow-up ( number of infectious episodes per year ) .
    • The average duration of episodes of respiratory tract infection (number of sickness days ) comparison of the 12- month duration of the study and observation to the pre-treatment period (12 months).
    • Changing the severity of infection by clinical symptoms - comparison of period of 12 months pre-treatment to the period of 12 months of treatment and follow-up
    • The number of antibiotic treatment- comparison of period of 12 months before treatment and 12 months of treatment and follow-up
    Ocena skuteczności krótkoterminowej:
    • Liczba epizodów infekcji dróg oddechowych– porównanie okresu 4 miesięcy przed i 4 miesięcy po rozpoczęciu 1 okresu leczenia
    • Średni czas trwania epizodów infekcji dróg oddechowych– (liczba chorobo-dni) –porównanie okresu 4 miesięcy przed i 4 miesięcy po rozpoczęciu 1 okresu leczenia
    • Zmiana stopnia ciężkości infekcji wg skali objawów klinicznych - porównanie okresu 4 miesięcy przed i 4 miesięcy po rozpoczęciu 1 okresu leczenia
    Ocena skuteczności długoterminowej:
    • Liczba epizodów infekcji dróg oddechowych- porównanie okresu 12 miesięcy sprzed leczenia i okresu 12 miesięcy trwania badania i obserwacji (liczba epizodów infekcyjnych w skali roku).
    • Średni czas trwania epizodów infekcji dróg oddechowych (liczba chorobo-dni) –porównanie okresu 12 miesięcy trwania badania i obserwacji do okresu sprzed leczenia (12 miesięcy).
    • Zmiana stopnia ciężkości infekcji wg skali objawów klinicznych- porównanie okresu 12 miesięcy sprzed leczenia i okresu 12 miesięcy trwania badania i obserwacji
    • Liczba antybiotykoterapii- porównanie okresu 12 miesięcy sprzed leczenia i 12 miesięcy trwania badania i obserwacji.
    E.5.1.1Timepoint(s) of evaluation of this end point
    after the end of the study
    po zakończeniu badania
    E.5.2Secondary end point(s)
    - Change in the results of cytometry of peripheral blood lymphocytes (CD3, CD4, CD8, CD19, CD16CD56, CD3/HLA-DR, CD45) obtained after 4 months of the study and observation in relation to the results obtained at the time of enrollment.
    - Change the results of blastic transformation of lymphocytes in cultures stimulated with PHA, after 4 months of the study comparing the results obtained at the time of enrollment.
    - Change in concentrations of IgG, IgA, IgM in serum, after 4 months of the study and observation in comparison to the results of these studies obtained at the time of enrollment.
    - Change in the concentration of Th1 cytokine profile, and Th17 and Th 2 (IL-2, IFN-gamma, TNF-alpha, IL-4, IL-6, IL-10 and IL-17) after 4 months of the study and follow-up in comparison to the results of these tests obtained at the time of enrollment.
    • Zmiana wyników badań cytometrycznych limfocytów krwi obwodowej (CD3, CD4, CD8, CD19, CD16CD56, CD3/HLA-DR, CD45) uzyskanych po 4 miesiącach trwania badania i obserwacji w odniesieniu do wyników uzyskanych w chwili włączenia do badania.
    • Zmiana wyniku testu transformacji blastycznej limfocytów w hodowlach stymulowanych PHA, po 4 miesiącach trwania badania porównanie do wyników uzyskanych w chwili włączenia do badania.
    • Zmiana stężeń IgG, IgA, IgM w surowicy, po 4 miesiącach trwania badania i obserwacji w odniesieniu do wyników powyższych badań uzyskanych w chwili włączenia do badania.
    • Zmiana stężenia cytokin profilu Th1, Th 2 i Th17 (IL-2, IFN-gamma, TNF-alfa,IL-4, IL-6, IL-10 i IL-17). po 4 miesiącach trwania badania i obserwacji w odniesieniu do wyników powyższych badań uzyskanych w chwili włączenia do badania.
    E.5.2.1Timepoint(s) of evaluation of this end point
    after the end of the study
    po zakończeniu badania
    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) 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 Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    ostatnia wizyta ostatniego uczestnika
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months24
    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 Yes
    F.1.1Number of subjects for this age range: 60
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children (2-11 years old)
    dzieci (w wieku 2-11 lat)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    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
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-04-14
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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