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    Summary
    EudraCT Number:2019-004240-30
    Sponsor's Protocol Code Number:PS-ISA-01
    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:2019-12-02
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-004240-30
    A.3Full title of the trial
    Phase IV, unicentric, multiple dose, clinical trial, with a single treatment arm to evaluate bronchopulmonary penetration of isavuconazole in pulmonary transplant recipients (PBISA01)
    ENSAYO CLÍNICO, FASE IV, UNICÉNTRICO, DOSIS MÚLTIPLE, CON UN ÚNICO BRAZO DE TRATAMIENTO PARA ANALIZAR LA PENETRANCIA BRONCOPULMONAR DE ISAVUCONAZOL EN PACIENTES RECEPTORES DE TRASPLANTE PULMONAR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    CLINICAL TRIAL TO ANALYZE THE BRONCHOPULMONARY PENETRANCE OF ISAVUCONAZOLE IN PULMONARY TRANSPLANT RECIPIENTS PATIENTS
    ENSAYO CLÍNICO PARA ANALIZAR LA PENETRANCIA BRONCOPULMONAR DE ISAVUCONAZOL EN PACIENTES RECEPTORES DE TRASPLANTE PULMONAR
    A.3.2Name or abbreviated title of the trial where available
    PS-ISA-01
    PS-ISA-01
    A.4.1Sponsor's protocol code numberPS-ISA-01
    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 SponsorFUNDACIÓN PARA LA INVESTIGACION BIOMEDICA HU PUERTA DE HIERRO MAJADAHONDA
    B.1.3.4CountrySpain
    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 supportPNEUMOLOGY DEPARTMENT (HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPNEUMOLOGY DEPARTMENT (HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA)
    B.5.2Functional name of contact pointPIEDAD USSETTI GIL
    B.5.3 Address:
    B.5.3.1Street AddressC/Manuel de Falla 1
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28222
    B.5.3.4CountrySpain
    B.5.4Telephone number34911917479
    B.5.5Fax number34911917650
    B.5.6E-mailmariapiedad.ussetti@salud.madrid.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 CRESEMBA
    D.2.1.1.2Name of the Marketing Authorisation holderBasilea Pharmaceutica Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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/3/14/1284
    D.3 Description of the IMP
    D.3.1Product nameCRESEMBA
    D.3.4Pharmaceutical form Capsule
    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 INNisavuconazole
    D.3.9.1CAS number 241479-67-4
    D.3.9.2Current sponsor codeCRESEMBA
    D.3.9.3Other descriptive nameISAVUCONAZOLE
    D.3.9.4EV Substance CodeSUB128138
    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
    Lung transplant recipients with a diagnosis of invasive fungal disease
    Pacientes receptores de trasplante pulmonar con diagnóstico de enfermedad fúngica invasiva.
    E.1.1.1Medical condition in easily understood language
    Patients with lung transplantation with invasive fungal infection
    Pacientes con trasplante pulmonar con infección invasiva por hongos
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    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
    Describe the pharmacokinetic profile of oral isavuconazole at the bronchopulmonary level through the degree of penetration into the epithelial lining fluid and the alveolar macrophages in patients receiving lung transplants diagnosed with invasive fungal disease.
    Describir el perfil farmacocinético de isavuconazol oral a nivel broncopulmonar a través del grado de penetrancia en el fluido de revestimiento epitelial y los macrófagos alveolares en pacientes receptores de trasplante pulmonar con diagnóstico de enfermedad fúngica invasiva
    E.2.2Secondary objectives of the trial
    - Establish the relationship between the pulmonary and systemic exposure of Isavuconazole.
    - To evaluate the potential pharmacokinetic interaction of Isavuconazole with immunosuppressive drugs (tacrolimus and mycophenolate). This interaction will be studied in the steady state of the drugs evaluated.
    - Evaluate the safety and tolerability of Isavuconazole.
    - Establecer la relación entre la exposición pulmonar y sistémica de Isavuconazol.
    - Evaluar la potencial interacción farmacocinética de Isavuconazol con fármacos inmunosupresores (tacrolimus y micofenolato). Esta interacción se estudiará en el estado de equilibrio estacionario de los fármacos evaluados.
    - Evaluar la seguridad y tolerabilidad de Isavuconazol.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Receptors of a lung transplant older than 18 years who, with indication of treatment with isavuconazole according to the technical sheet.
    - Will and ability to meet scheduled visits, treatment plan, laboratory analysis and other study procedures.
    - They must be legally competent and able to understand, sign and date the informed consent form.
    - Signing of the written informed consent in accordance with ICH / GCP and local legislation, obtained before any study procedure.
    - Receptores de un trasplante pulmonar mayores de 18 años que, con indicación de tratamiento con isavuconazol de acuerdo a la ficha técnica.
    - Voluntad y capacidad para cumplir con las visitas programadas, plan de tratamiento, análisis de laboratorio y otros procedimientos del estudio.
    - Deben ser jurídicamente competentes y ser capaces de entender, firmar y fechar el formulario de consentimiento informado.
    - Firma del consentimiento informado escrito conforme a ICH/GCP y a la legislación local, obtenido antes de cualquier procedimiento de estudio.
    E.4Principal exclusion criteria
    - Allergy or intolerance to isavuconazole.
    - Contraindication for bronchoscopy and / or BAL.
    - Any clinical condition, and / or analytical alteration to participate in the study.
    - Individuals who show inability to follow the instructions or collaborate during the study.
    - Women with positive results of the pregnancy or breastfeeding test.
    - Having participated in another clinical trial during the 3 months prior to the start of the study in which a research drug or a commercially available drug was tested.
    - Lack of will or inability to follow the procedures described in the protocol.
    - Inability to grant written informed consent.
    - Alergia o intolerancia a isavuconazol.
    - Contraindicación para realización broncoscopia y/o BAL.
    - Cualquier condición clínica, y/o alteración analítiva como para participar en el estudio.
    - Individuos que muestren incapacidad para seguir las instrucciones o colaborar durante el desarrollo del estudio.
    - Mujeres con resultados positivos de la prueba de embarazo o en periodo de lactancia.
    - Haber participado en otro ensayo clínico durante los 3 meses previos al inicio del estudio en el que se probó un fármaco en investigación o un medicamento comercialmente disponible.
    - Falta de voluntad o incapacidad para seguir los procedimientos descritos en el protocolo.
    - Incapacidad para otorgar el consentimiento informado por escrito.
    E.5 End points
    E.5.1Primary end point(s)
    Isovuconazole Penetration in Lung
    The concentrations of isavuconazole in plasma, epithelial lining fluid (ELF) and in alveolar macrophages (CA) will be determined by reverse phase HPLC (RP-HPLC).
    - Serum isavuconazole levels. Four determinations will be made per patient: 72 hours after the start of treatment, the day of bronchoscopy, simultaneously with the BAL and 7 days after the start of treatment.
    - Levels of isavuconazole in epithelial lining fluid (ELF) and in alveolar macrophages (CA), will be obtained from bronchoalveolar lavage (BAL).
    Data from the cell count, percentage of alveolar cells and volume of cell lining fluid will be presented at the different times when bronchoscopy is performed.
    The volume of cell lining fluid will be estimated using the concentration of urea in plasma and in LBA from the following formula:
    Estimated ELF volume = Amount of total UREA in LBA (mg) / plasma UREA concentration (mg / mL)
    The AUC of isavuconazole will be estimated at the ELF level and in CAs. The concentration-time-dependent curves in ELF and CA will be calculated using non-compartmental analyzes.
    The ratio between ELF / plasma and CA / plasma will be estimated from the average of the values ​​of the patients included in each group.
    Penetración de isovuconazol en pulmón
    Se determinarán las concentraciones de isavuconazol en plasma, fluido de revestimiento epitelial (ELF) y en los macrófagos alveolares (CA) mediante HPLC en fase reversa (RP-HPLC).
    - Niveles isavuconazol en suero. Se realizarán 4 determinaciones por paciente: a las 72 h de iniciado el tratamiento, el día de la broncoscopia, simultáneamente a la realización del BAL y a los 7 días de iniciado el tratamiento.
    - Niveles de isavuconazol en fluido de revestimiento epitelial (ELF) y en los macrófagos alveolares (CA), se obtendrán a partir del lavado broncoalveolar (BAL).
    Se presentarán datos del recuento celular, porcentaje de células alveolares y volumen de líquido de revestimiento celular a los diferentes tiempos en que se realice la broncoscopia.
    El volumen de líquido de revestimiento celular se estimará utilizando la concentración de urea en plasma y en LBA a partir de la siguiente fórmula:
    Volumen estimado de ELF= Cantidad de UREA total en LBA (mg)/concentración de UREA en plasma (mg/mL)
    Se estimará el AUC de isavuconazol a nivel del ELF y en CAs. Mediante el uso de análisis no-compartimentales se calcularán las curvas concentración-tiempo dependiente en ELF y CA.
    Se estimará la razón entre ELF/plasma y CA/plasma a partir de la media de los valores de los pacientes incluidos en cada grupo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 hours after the start of treatment, the day of bronchoscopy, simultaneously with the BAL and 7 days after the start of treatment.
    72 h de iniciado el tratamiento, el día de la broncoscopia, simultáneamente a la realización del BAL y a los 7 días de iniciado el tratamiento.
    E.5.2Secondary end point(s)
    Interaction Evaluation: Tacrolimus and mycophenolate concentrations will be determined before and after 72 hours, 96 hours and 7 days after the start of treatment with isavuconazole.
    The percentage of patients who required dose adjustment of the immunosuppressive drug after the start of treatment with isavuconazole will be determined.

    Systemic Security Assessment: According to the recommendations of the EMA (EMA / CPMP / EWP / 280/96 Corr1), systemic safety will be assessed according to the record of adverse effects, physical examination of patients, and the result of analytical studies
    Evaluación de la interacción: Se determinarán las concentraciones de tacrolimus y micofenolato antes y a las 72 horas, 96h y a los 7 días del inicio de tratamiento con isavuconazol.
    Se determinará el porcentaje de pacientes que precisaron ajuste de dosis del fármaco inmunosupresor tras el inicio de tratamiento con isavuconazol.

    Evaluación de la seguridad sistémica: De acuerdo con las recomendaciones de la EMA (EMA/CPMP/EWP/280/96 Corr1), la seguridad sistémica se evaluará atendiendo al registro de los efectos adversos, a la exploración física de los pacientes, y al resultado de los estudios analíticos
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    NO aplicable
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    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 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
    The study will continue until the last eligible patient has completed the initial 14 days of treatment. The completion of the trial is expected to coincide with the last follow-up visit of the last patient included.
    El estudio continuará hasta que el último paciente que fue elegible haya completado los 14 días iniciales de tratamiento. Se prevé que la finalización del ensayo coincida con la última visita de seguimiento del último paciente incluido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 12
    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 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 state12
    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)
    IN ACCORDANCE WITH CLINICAL PRACTICE
    DE ACUERDO CON LA PRÁCTICA CLINICA
    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 Decision2020-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-29
    P. End of Trial
    P.End of Trial StatusOngoing
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