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    Summary
    EudraCT Number:2009-015768-33
    Sponsor's Protocol Code Number:EMR700773-003
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-28
    Trial results View 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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2009-015768-33
    A.3Full title of the trial
    A Phase IIIb, Multicenter, Open-Label, Randomized, Controlled Study of the Efficacy, Safety, and Population Pharmacokinetics of Sapropterin Dihydrochloride (Kuvan) in Phenylketonuria (PKU) Patients <4 Years Old
    Studio di fase IIIb multicentrico, in aperto, randomizzato, controllato sull'efficacia, la sicurezza e la farmacocinetica di popolazione di sapropterina dicloridrato (Kuvan) nei pazienti affetti da fenilchetonuria (PKU) di eta' <4 anni
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    SPARK (Safety Paediatric efficAcy phaRmacokinetic with Kuvan)
    SPARK (Safety Paediatric efficAcy phaRmacokinetic with Kuvan)
    A.3.2Name or abbreviated title of the trial where available
    SPARK
    SPARK
    A.4.1Sponsor's protocol code numberEMR700773-003
    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 SponsorMERCK SERONO SA
    B.1.3.4CountrySwitzerland
    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 supportMerck Serono S.A. - Geneva
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMERCK KGAA
    B.5.2Functional name of contact pointCOMMUNICATION CENTER MERCK KGAA
    B.5.3 Address:
    B.5.3.1Street AddressFRANKFURTER STRASSE 250
    B.5.3.2Town/ cityDARMSTADT
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+49 6151 72 5200
    B.5.5Fax number+49 6151 72 2000
    B.5.6E-mailservice@merck.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name KUVAN
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SERONO EUROPE LTD
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/04/199
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Yes
    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 INNSAPROPTERIN
    D.3.9.1CAS number 62989337
    D.3.9.4EV Substance CodePRD103190
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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
    Phenylketonuria
    Fenilchetonuria
    E.1.1.1Medical condition in easily understood language
    Phenylketonuria
    Fenilchetonuria
    E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level SOC
    E.1.2Classification code 10010331
    E.1.2Term Congenital, familial and genetic disorders
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10034872
    E.1.2Term Phenylketonuria
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Evaluate the efficacy after 26 weeks of Kuvan treatment + Phe-restricted diet therapy in increasing dietary Phe tolerance, as compared to dietary therapy alone in <4 year-old infants and children with phenylketonuria (PKU). Phe tolerance will be defined as the amount of dietary Phe (mg/kg/day) ingested while maintaining blood Phe levels within the range of 120-360 μmol/L (defined as ≥120 to < 360 μmol/L). 2. Evaluate the safety after 26 weeks of Kuvan treatment in <4 year-old infants and children with PKU. 3. Evaluate BH4 (tetrahydrobiopterin; sapropterin) blood levels via scheduled PopPK samplings.
    1. Valutare l`efficacia del trattamento con Kuvan dopo 26 settimane + terapia mediante dieta povera di fenilalanina nell`aumentare la tolleranza alla fenilalanina assunta con la dieta rispetto alla sola terapia mediante dieta nei neonati e nei bambini di eta` &lt;4 anni affetti da fenilchetonuria (PKU). La tolleranza alla fenilalanina verra` definita come la quantita` di fenilalanina assunta con la dieta (mg/kg/die) che e` possibile ingerire mantenendo valori ematici di fenilalanina entro un range di 120-360 μmol/l (definito come da ≥120 a &lt; 360 μmol/l). 2. Valutare dopo 26 settimane la sicurezza del trattamento con Kuvan nei neonati e nei bambini affetti da fenilchetonuria di eta` &lt;4 anni. 3. Valutare i livelli ematici di BH4 (tetraidrobiopterina; sapropterina) tramite prelievi programmati per la valutazione della farmacocinetica di popolazione.
    E.2.2Secondary objectives of the trial
    1. Evaluate blood Phe levels for all subjects during the 26-week Study Period. 2. Evaluate the effectiveness of Kuvan treatment in increasing dietary Phe tolerance, as compared to pre- Kuvan treatment during the 26-week Study Period in <4 year-old infants and children with PKU. 3. Assess neurodevelopmental function during Kuvan treatment, as compared to dietary treatment alone, during the 26-week Study Period in <4 year-old infants and children with PKU. 4. Assess potential effects on blood pressure during the 26-weeks Study Period and the 3-year Extension Period. 5. Assess potential effects on growth during the 26-weeks Study Period and the 3-year Extension Period. 6. Evaluate long-term safety, neurodevelopmental outcomes, dietary Phe tolerance, and blood Phe levels in the 3- year Extension Period. 7. Investigate in BH4-responsive individuals the predictive value of the phenylalanine hydroxylase (PAH) genotype.
    1. Valutare i livelli ematici di fenilalanina di tutti i soggetti durante il periodo di studio di 26 settimane. 2. Valutare l'efficacia del trattamento con Kuvan nell'aumentare la tolleranza alla fenilalanina assunta con la dieta rispetto al trattamento pre-Kuvan nel periodo di studio di 26 settimane nei neonati e nei bambini affetti da fenilchetonuria (PKU) di eta' &lt;4 anni. 3. Valutare la funzione dello sviluppo neurale nel corso del trattamento con Kuvan confrontandola con il solo trattamento mediante dieta nei neonati e nei bambini di eta' &lt;4 anni affetti da fenilchetonuria (PKU) nel periodo di studio di 26 settimane. 4. Valutare i potenziali effetti sulla pressione sanguigna nel periodo di studio di 26 settimane e nel periodo di estensione di 3 anni. 5. Valutare i potenziali effetti sulla crescita nel periodo di studio di 26 settimane e nel periodo di estensione di 3 anni. 6. ecc.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Diagnosis: Confirmed clinical and biochemical PKU. In addition to the above diagnosis, the inclusion criteria to be satisfied for enrolment in this study are as follows: 1. Male or female PKU infants and young children <4 years of age at the scheduled Day 1 visit of the 26-week Study Period (taking into consideration the maximum of 21 days in the Screening Period). 2. At least two previous blood Phe levels ≥ 400 μmol/L obtained on 2 separate occasions. 3. Previously responded, as assessed by the Investigator, to a BH4 test, if all 3 of the following criteria are satisfied: a. The BH4 dose was 20 mg/kg/day; b. The duration of the test was at least for 24 hours; and c. Blood Phe levels decreased by at least 30%. NOTE: If a patient has not undergone a BH4 test prior to Screening, such a test must be performed during Screening, and all 3 of the above criteria must be satisfied for the subject to be eligible for entry into this study. 4. Defined level of dietary Phe tolerance consistent with the diagnosis of PKU; 5. Good adherence to dietary treatment, including prescribed dietary Phe restriction and prescribed amounts of Phe-free protein supplements and low- Phe foods. 6. Maintenance of blood Phe levels within the therapeutic target range of 120-360 μmol/L (defined as ≥120 to <360 μmol/L) over a 1-month period prior to Screening, as assessed by the Investigator. 7. Parent(s) and/or guardian(s) willing to comply with all study procedures, maintain strict adherence to the diet, and willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study procedures.
    Diagnosi: fenilchetonuria clinica e biochimica confermata. Oltre alla diagnosi riportata sopra, i criteri di inclusione da soddisfare per poter essere arruolati in questo studio sono i seguenti: 1. neonati e bambini maschi o femmine affetti da fenilchetonuria di eta` &lt;4 anni al momento della visita programmata il Giorno 1 del periodo di studio di 26 settimane (prendendo in considerazione un massimo di 21 giorni del periodo di screening); 2. almeno due precedenti livelli ematici di fenilalanina ≥ 400 μmol/l, ottenuti in 2 occasioni separate; 3. avere precedentemente risposto, come valutato dallo sperimentatore, a un test per la tetraidrobiopterina, nel caso in cui vengano soddisfatti tutti e 3 i seguenti criteri: a. il dosaggio di tetraidrobiopterina era di 20 mg/kg/die; b. la durata del test e` stata di almeno 24 ore; e c. i livelli ematici di fenilalanina sono stati ridotti almeno del 30%. NOTA: nel caso in cui un paziente non sia stato sottoposto a un test per la tetraidrobiopterina prima dello screening, tale test dovra` essere eseguito durante lo screening, e tutti e 3 i criteri riportati sopra dovranno essere soddisfatti per far si` che il soggetto risulti idoneo alla partecipazione a questo studio; 4. livelli definiti di tolleranza alla fenilalanina assunta con la dieta coerenti con la diagnosi di fenilchetonuria; 5. buona aderenza al trattamento mediante dieta, inclusa la riduzione prescritta della fenilalanina assunta con la dieta, le quantita` prescritte di integratori di proteine privi di fenilalanina e degli alimenti poveri di fenilalanina; 6. mantenimento dei livelli ematici di fenilalanina all`interno del range terapeutico target di 120-360 μmol/l (definito come da ≥120 a &lt;360 μmol/l) per un periodo di oltre 1 mese prima dello screening, come valutato dallo sperimentatore; 7. i genitori/tutori dovranno avere la volonta` di rispettare tutte le procedure dello studio, mantenere una stretta conformita` alla dieta e avere la volonta` e la capacita` di fornire un consenso informato per iscritto e firmato dopo che la natura dello studio sara` stata spiegata loro e prima dell`inizio delle procedure dello studio.
    E.4Principal exclusion criteria
    Use of Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin within the previous 30 days, unless for the purposes of a BH4 responsiveness test. 2. Previous exposure to Kuvan, Biopten, or any unregistered preparation of tetrahydrobiopterin for >30 days. 3. Known hypersensitivity to Kuvan or its excipients. 4. Known hypersensitivity to other approved or nonapproved formulations of tetrahydrobiopterin. 5. Previous diagnosis of BH4 deficiency. 6. Current use of methotrexate, trimethoprim, or other dihydrofolate reductase inhibitors. 7. Current use of medications that are known to affect nitric oxide synthesis, metabolism or action. 8. Current use of levodopa. Current use of experimental or unregistered drugs that may affect the study outcomes. 10. Inability to comply with study procedures. 11. Inability to tolerate oral intake. 12. History of organ transplantation. 13. Concurrent disease or condition that would interfere with study participation or increase the risk for adverse events, including seizure disorders, corticosteroid administration, active malignancy, diabetes mellitus, severe congenital heart disease, renal or hepatic failure. 14. Other significant disease that in the Investigator`™s opinion would exclude the subject from the trial. 15. Any condition that, in the view of the Principal Investigator renders the subject at high risk for failure to comply with treatment or to complete the study.
    1. l'uso di Kuvan, Biopten o di qualsiasi altra preparazione non registrata a base di tetraidrobiopterina nei 30 giorni precedenti, eccetto che per lo svolgimento del test per la valutazione della risposta alla tetraidrobiopterina; 2. precedente esposizione a Kuvan, Biopten o a qualsiasi altra preparazione non registrata a base di tetraidrobiopterina per un periodo &gt;30 giorni; 3. ipersensibilita' nota a Kuvan o ai suoi eccipienti; 4. ipersensibilita' nota ad altre formulazioni, approvate o meno, a base di tetraidrobiopterina; 5. precedente diagnosi di insufficienza di tetraidrobiopterina; 6. uso attuale di metotressato, trimetoprim o di altri inibitori della diidrofolato reduttasi; 7. uso attuale di farmaci noti per l'influenzare la sintesi, il metabolismo o l'azione dell'ossido di azoto; 8. uso attuale di levodopa; 9. uso attuale di farmaci sperimentali o non registrati che potrebbero influenzare i risultati dello studio; 10. impossibilita' a rispettare le procedure dello studio; 11. intolleranza alla somministrazione per via orale; 12. anamnesi di trapianto di organi; 13. malattia o patologia concomitante che potrebbe interferire con la partecipazione allo studio o aumentare il rischio di eventi avversi, inclusi disturbi convulsivi, somministrazione di corticosteroidi, neoplasia maligna attiva, diabete mellito, grave malattia cardiaca congenita e blocco renale o epatico; 14. altre malattie significative che, secondo lo sperimentatore, potrebbero escludere il soggetto dalla sperimentazione; 15. qualsiasi patologia che, dal punto di vista dello sperimentatore, renda estremamente difficile per il soggetto rispettare il trattamento o completare lo studio
    E.5 End points
    E.5.1Primary end point(s)
    Dietary Phe tolerance after 26 weeks (6 months) of treatment with Kuvan + a Phe-restricted diet, as compared to just a Phe-restricted diet alone.
    Tolleranza alla fenilalanina assunta con la dieta dopo 26 settimane (6 mesi) di trattamento con Kuvan + dieta povera di fenilalanina confrontata con quella ottenuta con la sola dieta povera di fenilalanina
    E.5.1.1Timepoint(s) of evaluation of this end point
    AT THE END OF STUDY PART (26 WEEKS) OR AT THE END OF THE EXTENSION PERIOD
    VEDI TESTO INGLESE
    E.5.2Secondary end point(s)
    Evaluate blood Phe levels for all subjects during the 26-week Study Period. 2. Evaluate the effectiveness of Kuvan treatment in increasing dietary Phe tolerance, as compared to pre-Kuvan treatment during the 26-week Study Period in <4 year-old infants and children with PKU.
    1. Livelli ematici di fenilalanina nel corso del periodo di studio. 2. Cambiamenti rispetto al basale (prima dell`arruolamento) nella tolleranza alla fenilalanina assunta con la dieta dopo 26 settimane (6 mesi) di trattamento con Kuvan + dieta povera di fenilalanina confrontata con quella ottenuta con la sola dieta povera di fenilalanina
    E.5.2.1Timepoint(s) of evaluation of this end point
    after 26 weeks (6 months) of treatment with Kuvan
    dopo 26 settimane (6 mesi) di trattamento con Kuvan
    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 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) 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 Yes
    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
    solo dieta
    diet only
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    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
    Turkey
    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
    Data base lock
    Data base lock e risoluzione di eventuali queries, follow-up di eventi avversi, chiusura finale ai centri e database lock (vedere definizione § 5.2.7 del protocollo di studio)
    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 months42
    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 months42
    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: 50
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 25
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 25
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    paediatric patients less than four years of age
    bambini di eta' inferiore a 4 anni
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 44
    F.4.2.2In the whole clinical trial 50
    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)
    The investigator is responsible to plan the treatment of care for the subject after they have ended their participation in the trial
    Lo sperimentatore è responsabile di pianificare il trattamento di cura per i soggetti al termine della loro partecipazione alla sperimentazione
    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 Decision2011-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-11-17
    P. End of Trial
    P.End of Trial StatusCompleted
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