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    Summary
    EudraCT Number:2014-004519-35
    Sponsor's Protocol Code Number:PANC2002
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-12-04
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2014-004519-35
    A.3Full title of the trial
    A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
    Estudio de búsqueda de dosis en fase II, multicéntrico, con grupo paralelo, con comparador activo, aleatorizado y doble ciego para evaluar la eficacia y la seguridad de dosis diferentes de Kreon de liberación inmediata en sujetos con insuficiencia pancreática exocrina debida a fibrosis quística
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
    Estudio de búsqueda de dosis en fase II, multicéntrico, con grupo paralelo, con comparador activo, aleatorizado y doble ciego para evaluar la eficacia y la seguridad de dosis diferentes de Kreon de liberación inmediata en sujetos con insuficiencia pancreática exocrina debida a fibrosis quística
    A.4.1Sponsor's protocol code numberPANC2002
    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 SponsorAbbott Laboratories GmbH
    B.1.3.4CountryGermany
    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 supportAbbott Laboratories GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNuvisan Clinical Development Solutions Spain, S.L.U.
    B.5.2Functional name of contact pointAna Moreno Sánchez
    B.5.3 Address:
    B.5.3.1Street Addressc/ Rosa de Lima, 1bis. Edificio Alba.
    B.5.3.2Town/ cityLas Matas / Madrid
    B.5.3.3Post code28290
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913 726 043
    B.5.5Fax number+34913 726 060
    B.5.6E-mailupmmadrid@nuvisan.com
    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 nameKREON de Liberación Inmediata
    D.3.4Pharmaceutical form Capsule, hard
    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 INNNOT APPLICABLE
    D.3.9.1CAS number 8049-47-6
    D.3.9.2Current sponsor codeKREON de liberación inmediata
    D.3.9.3Other descriptive namePANCREATINA (Páncreas Polvo
    D.3.9.4EV Substance CodeSUB12545MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4000 to 30000
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP 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 Kreon 25 000
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories GmbH
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 nameKreon® 25,000
    D.3.4Pharmaceutical form Capsule, hard
    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 INNnot assigned
    D.3.9.1CAS number 8049-47-6
    D.3.9.3Other descriptive namePANCREATINA (Páncreas Polvo)
    D.3.9.4EV Substance CodeSUB12545MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25000
    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) 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Pancreatic exocrine Insufficiency due to Cystic Fibrosis
    Insuficiencia pancreática exocrina debida a fibrosis quística
    E.1.1.1Medical condition in easily understood language
    Maldigestion of diatery macronutrients (pancreas not producing enough enzymes for digestion of fat, sugars and proteins) in Cystic Fibrosis
    Mala digestión de macronutrientes de la dieta (el páncreas no produce suficinetes encima para la digestión de la grasa, azúcares y proteinas) en Fibrosis Quística
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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
    To compare and model the efficacy of four different doses of Creon Immediate Release (IR) and the active control (Creon® (Delayed Release/Gastro-Resistant) [Creon® DR/GR]) in subjects with pancreatic exocrine insufficiency (PEI) due to cystic fibrosis (CF). The primary efficacy objective is based on the evaluation of fat digestion as measured by coefficient of fat absorption (CFA) (%).
    Comparar y modelar la eficacia de cuatro dosis diferentes de Kreon de liberación inmediata y el comparador activo (Kreon® (liberación retardada/gastrorresistente) [Kreon® [DR/GR]) en sujetos con insuficiencia pancreática exocrina (IPE) debida a fibrosis quística (FQ). El objetivo principal de eficacia se basa en la evaluación de la digestión de grasas determinada mediante el coeficiente de absorción de grasas (CAG) (%).
    E.2.2Secondary objectives of the trial
    The secondary efficacy objective is to evaluate the effect on protein digestion (measured by CNA), stool fat content and stool weight, of different doses of Creon IR in comparison to Creon® (DR/GR) in subjects with PEI due to CF.

    The safety objective is to determine the clinical safety of Creon IR based on the evaluation of clinical symptomatology associated with PEI (stool frequency, stool consistency, abdominal pain, flatulence), vital signs, physical examination findings, safety laboratory values and adverse events (AEs) in subjects with PEI due to CF.
    El objetivo secundario de eficacia es comparar la digestión de proteínas (determinada mediante el coeficiente de absorción de nitrógeno [CAN]), el contenido de grasa en heces y el peso de las heces de 4 dosis diferentes de Kreon de liberación inmediata y Kreon® (DR/GR) en sujetos con IPE debida a FQ.

    El objetivo relacionado con la seguridad es determinar la seguridad clínica de Kreon de liberación inmediata en función de la evaluación de la sintomatología clínica asociada con la IPE (frecuencia de las deposiciones, consistencia de la heces, dolor abdominal, flatulencia), constantes vitales, datos de exploraciones físicas, valores de pruebas de seguridad y acontecimientos adversos (AA) en sujetos con IPE debida a FQ.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has voluntarily signed and dated the ICF. For subjects aged less than 18 years, the parents, or a legally acceptable representative, must sign consent and, as required by the IEC, assent will be given by the subject.
    2. Subject is 12 years old or older at the time of consent signature.
    3. Subject has a diagnosis of CF previously confirmed by:
    - a sweat chloride test > or equal to 60 mmol/Ls and/or
    - two CF causing CFTR mutations and
    - CF clinical features7,8.
    4. Subject has a documented clinically confirmed diagnosis of pancreatic exocrine insufficiency.
    5. Subject has human fecal elastase < 100 µg/g stool at screening.
    6. Subject has PEI that is currently clinically controlled (no clinically overt steatorrhea or diarrhea) under treatment with a commercially available PERT, on an individually established dose regimen for more than 3 months, with a daily dose not exceeding 10,000 U lipase/kg/day.
    7. Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 7 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g., Depo Provera?), an intrauterine device, or an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide
    1. El sujeto ha firmado y fechado voluntariamente el documento de consentimiento informado (CI). En el caso de sujetos menores de 18 años, los progenitores o un representante legal deberán firmar el consentimiento, y si lo requiere el Comité Ético de Investigación Clínica (CEIC), el sujeto dará su asentimiento.
    2. El sujeto tiene 12 años o más en el momento de la firma del consentimiento.
    3. El sujeto tiene un diagnóstico de FQ confirmado previamente por:
    ? una prueba de cloruro en sudor > o igual a 60 mmmol/Ls y/o
    ? dos FQ causando mutaciones CFTR y
    ? síntomas de FQ 7,8.
    4. El sujeto tiene un diagnóstico documentado confirmado clínicamente de insuficiencia pancreática exocrina.
    5. El sujeto tiene una concentración de elastasa fecal humana <100 µg/g de heces en el momento de la selección.
    6. El sujeto tiene IPE que en la actualidad está clínicamente controlada (esteatorrea o diarrea clínicamente no sintomática) en tratamiento con una TSEP disponible en el mercado, a una pauta posológica establecida de forma individualizada durante más de 3 meses, con una dosis diaria que no sobrepase de 10 000 U de lipasa/kg/día.
    7. Las mujeres en edad fértil deben estar de acuerdo en continuar usando un método anticonceptivo médicamente aceptable durante todo el estudio y en los 7 días inmediatamente posteriores a la última dosis del fármaco del estudio. Los métodos anticonceptivos médicamente aceptables son: ligadura de trompas bilateral o el uso de un implante anticonceptivo, inyección anticonceptiva (p. ej., Depo-Provera?), dispositivo intrauterino o anticonceptivo oral tomado de forma continuada durante los últimos tres meses y que la paciente acepte continuar tomando durante el estudio o adoptar otro método anticonceptivo, o un método de doble barrera que consista en una combinación de cualquiera de los siguientes métodos: diafragma, capuchón cervical, preservativo o espermicida.
    E.4Principal exclusion criteria
    1. Subject is < 18 years of age and has a Body Mass Index (BMI) Z-Score below -1.59 (minus 1.5).
    2. Subject has a history of any of the following gastrointestinal disorders:
    a. pancreatitis within 6 months prior to study entry;
    b. fibrosing colonopathy;
    c. distal ileal obstruction syndrome (DIOS) within 6 months prior to study entry;
    d. celiac disease;
    e. gastric bypass or partial/total gastrectomy;
    f. Crohn?s disease;
    g. small bowel surgery (other than minor resection due to meconium ileus without resulting in malabsorption syndrome).
    h. Any type of malignancy involving the digestive tract in the last 5 years
    3. Subjects with diabetes mellitus, for which the study specific dietary requirements may not be appropriate (See Section 8.1.1).
    4. Subject has a history of other endocrine or respiratory (except mild asthma) medical illness non-related to CF, which might limit participation in or completion of the study.
    5. Subject has a history of any clinically significant neurological, cardiac, renal, hepatic (including Hepatitis B or C), hematologic or psychiatric disease or disorder, or any other uncontrolled medical illness (except cystic fibrosis) which might limit participation in or completion of the study.
    6. Subjects requiring concomitant treatment with any medication not allowed by the protocol or is expected to be needed.
    7. Subjects requiring Naso-gastric, G-tubes or J-tubes.
    8. Subject is currently participating in any other interventional clinical study or has taken any experimental drug within 30 days prior to Screening.
    9. Subject is known to be HIV-positive.
    10. Subject has a history of allergic reaction or significant sensitivity to pancreatin or inactive ingredients (excipients) of Creon® (DR/GR) or Creon IR
    1. El sujeto es menor de 18 años y tiene un índice de masa corporal (IMC) Z-Score por debajo de -1.59 (menos 1.5).
    2. El sujeto tiene antecedentes de cualquier de los siguientes trastornos gastrointestinales:
    a. pancreatitis en los 6 meses previos a entrar en el estudio;
    b. colonopatía fibrosante;
    c. síndrome de obstrucción intestinal distal (SOID) en los 6 meses previos a la entrada en el estudio;
    d. enfermedad celíaca;
    e. derivación gástrica o gastrectomía parcial/total;
    f. enfermedad de Crohn;
    g. cirugía del intestino delgado (aparte de resección menor debida a íleo meconial sin resultado de síndrome de malabsorción);
    h. cualquier tipo de neoplasia maligna que afecte al tubo digestivo en los últimos 5 años.
    3. Sujetos con diabetes mellitus para los que las necesidades alimentarias específicas del estudio puedan no ser apropiadas (véase la sección 8.1.1).
    4. El sujeto tiene antecedentes de otra enfermedad endocrina o respiratoria (excepto asma leve) no relacionada con la FQ que pudiera limitar su participación o la conclusión del estudio.
    5. El sujeto tiene antecedentes de cualquier enfermedad o trastorno neurológico, cardíaco, renal, hepático (incluido hepatitis B o C), hematológico o psiquiátrico clínicamente significativo, o cualquier otra enfermedad no controlada (excepto fibrosis quística) que pudiera limitar su participación o la conclusión del estudio.
    6. Sujetos que requieren o se espera que necesiten tratamiento concomitante con cualquier medicación no permitida por el protocolo.
    7. Sujetos que requieren sondas nasogástricas, sondas gástricas o sondas de yeyunostomía.
    8. El sujeto está participando actualmente en cualquier otro estudio clínico intervencionista o ha tomado cualquier fármaco experimental en los 30 días previos a la selección.
    9. Se sabe que el sujeto es positivo para VIH.
    10. El sujeto tiene antecedentes de reacción alérgica o sensibilidad significativa a la pancreatina o los componentes inactivos (excipientes) de Kreon® (DR/GR) o Kreon de liberación inmediata.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy criterion is the CFA (Coefficient of Fat Absorption).
    CFA will be calculated from fat intake and fat excretion, according to the formula:
    CFA (%) = 100 [fat intake ? fat excretion] / fat intake
    El criterio principal de valoración de la eficacia es el CAG (Coeficiente de Absorción de Grasas).
    El CAG se calculará a partir del aporte y la excreción de grasas, según la fórmula:
    CAG (%) = 100 [aporte de grasas ? excreción de grasas] / aporte de grasas
    E.5.1.1Timepoint(s) of evaluation of this end point
    The values at the end of the double-blind treatment period of the four different doses of Creon IR, and of the active control Creon®,will be compared .
    Se compararán al final del periodo de tratamiento doble ciego cuatro dosis diferentes de Kreon de liberación inmediata y el comparador activo Kreon®.
    E.5.2Secondary end point(s)
    Secondary efficacy criteria are the CNA (Coefficient of Nitrogen Absorption), stool fat content, and stool weight.
    CNA will be calculated from nitrogen intake and nitrogen according to the formula:
    CNA (%) = 100 [nitrogen intake ? nitrogen excretion] / nitrogen intake.

    The safety data collected during the study are vital signs, physical
    examination, safety laboratory values and adverses events.
    Los criterios secundarios de valoración de la eficacia son el CAN (Coeficiente de Absorción de Nitrógeno), el contenido en grasa de las heces y el peso de las heces.
    El CAN se calculará a partir del aporte y la excreción de nitrógeno, según la fórmula:
    CAN (%) = 100 [aporte de nitrógeno ? excreción de nitrógeno] / aporte de nitrógeno
    E.5.2.1Timepoint(s) of evaluation of this end point
    The values at the end of the double-blind treatment period of the four different doses of Creon IR, and of the active control Creon®, will be compared .

    Safety parameters are assessed throughout the study.
    Se compararán al final del periodo de tratamiento doble ciego cuatro dosis diferentes de Kreon de liberación inmediata y el comparador activo Kreon®.

    Los parámetros de seguridad serán controlados a lo largo del estudio.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial5
    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 EEA25
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    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: 39
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 39
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 39
    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
    For adolescents, the parents will have to give their consent. The adolescents will also have to give their assent.
    En el caso de adolescentes, los padres deberán otorgar su consentimiento. Los adolesdences deberán otorgar también su asentimiento.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    F.4.2.2In the whole clinical trial 78
    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 patient will return to original PERT therapy.
    El paciente volverá a su terapia TSEP original.
    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 Decision2015-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-09
    P. End of Trial
    P.End of Trial StatusOngoing
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