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    Summary
    EudraCT Number:2015-005519-34
    Sponsor's Protocol Code Number:ENVARUS
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-02-03
    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 number2015-005519-34
    A.3Full title of the trial
    Phase II, open, one-site, pilot Clinical trial for assessing the pharmacokinetic characteristics, safety and tolerability after conversion of the immuno-suppressive regimen with Advagraf® to Envarsus® in patients with stable pulmonary transplant.
    ENSAYO CLÍNICO DE FASE II, ABIERTO, UNICÉNTRICO, PILOTO PARA EVALUAR LAS CARACTERÍSTICAS FARMACOCINÉTICAS, SEGURIDAD Y TOLERABILIDAD, TRAS LA CONVERSIÓN DE UN RÉGIMEN INMUNOSUPRESOR CON ADVAGRAF® A ENVARSUS® EN PACIENTES CON TRASPLANTE PULMONAR ESTABLE.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II, open, one-site, pilot Clinical trial for assessing the pharmacokinetic characteristics, safety and tolerability after conversion of the immuno-suppressive regimen with Advagraf® to Envarsus® in patients with stable pulmonary transplant.
    ENSAYO CLÍNICO DE FASE II, ABIERTO, UNICÉNTRICO, PILOTO PARA EVALUAR LAS CARACTERÍSTICAS FARMACOCINÉTICAS, SEGURIDAD Y TOLERABILIDAD, TRAS LA CONVERSIÓN DE UN RÉGIMEN INMUNOSUPRESOR CON ADVAGRAF® A ENVARSUS® EN PACIENTES CON TRASPLANTE PULMONAR ESTABLE.
    A.3.2Name or abbreviated title of the trial where available
    TX PULMONARY
    TX PULMONAR
    A.4.1Sponsor's protocol code numberENVARUS
    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 SponsorFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    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 supportChiesi España S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    B.5.2Functional name of contact pointServicio de Neumología
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall Hebron
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934893000
    B.5.6E-mailaroman@vhebron.net
    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 Envarsus®
    D.2.1.1.2Name of the Marketing Authorisation holderChiesi Farmaceutici S.p.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Prolonged-release tablet
    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 INNTACROLIMUS
    D.3.9.1CAS number 104987-11-3
    D.3.9.4EV Substance CodeSUB10797MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.75 to 4
    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 stable
    Transplante pulmonar estable
    E.1.1.1Medical condition in easily understood language
    Lung transplant stable
    Transplante pulmonar estable
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLGT
    E.1.2Classification code 10038668
    E.1.2Term Respiratory and pulmonary investigations (excl blood gases)
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determinate and compare the tacrolimus pharmacokinetic profile in stable pulmonary transplant patients after the conversion 1:0.7 from Advagraf® to Envarsus®
    Determinar y comparar el perfil farmacocinético de tacrolimus en pacientes con trasplante de pulmón estable tras la conversión 1:0,7 de Advagraf® a Envarsus®
    E.2.2Secondary objectives of the trial
    - By a biopsy, assess the acute rejection incidence during 6 months post-conversion.
    - Determinate the safety profile with Envarsus treatment
    - Know the percentage of patients that show adverse event related to Envarus that causes hospitalization during 6 months post-conversion
    - Conocer la incidencia de rechazo agudo por biopsia durante 6 meses post-conversión.
    - Determinar el perfil de seguridad del tratamiento con Envarsus®.
    - Conocer el porcentaje de pacientes que presentan acontecimientos adversos de Envarsus® que causan hospitalización durante los 6 meses post-conversión.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients between 18 and 65 years, both inclusive
    - Patients with pulmonary transplant at least 6 months before the inclusion
    - Patients with immuno-suppressive regimen with Advagraf and that continue with the treatment at least 4 more weeks
    - Patients in stable phase with tacrolimus blood concentration of 5-15 µg/L, determinated in 2 times separated at least for 6 days during the selection period.
    - Patients capable of understanding purpose and risks of the study, that have been informed and have given their informed consent for participating in the trial.
    - Pacientes con edades comprendidas entre 18 y 65 años, ambas inclusive.
    - Pacientes con edades comprendidas entre 18 y 65 años, ambas inclusive.
    - Pacientes que reciban una pauta inmunosupresora basada en Advagraf® y en los que esté previsto continuar con el tratamiento un mínimo de 4 semanas.
    - Pacientes que en fase estable tengan unas concentraciones mínimas de tacrolimus en sangre de 5-15 µg/L determinadas en dos ocasiones independientes con una separación de al menos 6 días durante el periodo de selección.
    - Pacientes capaces de entender los propósitos y riesgos del estudio, que hayan sido informados y que otorguen su consentimiento informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    - Patients with neoplasia or neoplasia history 5 years before except cell carcinoma or non-metastasic epidermoid treated satisfactory.
    - Patients diagnosed with cystic fibrosis
    - Patients with generalized infections that needs treatment.
    - Patients with severe diarrhea, vomits, active peptic ulcer or digestive disorders that could affect tracrolimus absorption.
    - Patients that Advagraf® o Envarsus® are contraindicated
    - Evidence of acute rejection in the 3 previous months before the inclusion
    - Diagnosed chronic rejection.
    - Liver cirrhosis histologically confirmed
    - Patients with unacceptable pulmonary function
    - GPT (ALT), GOT (AST) and total bilirubin ? 3 ULN
    - Blood creatinine ? 2 mg/dl
    - Patients with drug addition, psychiatric disorder or condition that according to the investigator's opinion could difficult the patient participation.
    - Patients participating o has participated in another investigational trial within 28 days before the selection visit.
    - Patients HIV positive
    - Childbearing women that do not use effective birth control methods
    - Pregnancy or breast-feeding
    - Not sign the informed consent.
    - Pacientes con neoplasia o antecedentes de neoplasia en los 5 años anteriores excepto carcinoma basocelular o epidermoide no metastásico tratado satisfactoriamente.
    - Pacientes diagnosticados de fibrosis quística.
    - Pacientes con infección generalizada que requieran tratamiento.
    - Pacientes con diarrea severa, vómitos, úlcera péptica activa, o trastornos digestivos que puedan afectar la absorción de tacrolimus.
    - Pacientes en los que esté contraindicado el tratamiento con Advagraf® o Envarsus® según ficha técnica.
    - Existencia de un episodio de rechazo agudo en los tres meses previos a la inclusión.
    - Rechazo crónico diagnosticado.
    - Cirrosis hepática probada histológicamente.
    - Pacientes que presenten una función pulmonar no aceptable.
    - GPT (ALT), GOT (AST) y bilirrubina total ? 3 ULN
    - Creatinina sérica ? 2 mg/dl
    - Pacientes con alguna toxicomanía, trastorno psiquiátrico o afección que según el criterio del investigador pueda dificultar la participación.
    - Pacientes que participan simultáneamente o han participado en otro estudio de investigación en los 28 días previos a la entrada en el estudio.
    - Pacientes VIH positivos.
    - Mujeres en edad fértil que no utilicen métodos anticonceptivos eficaces
    - Embarazo y lactancia.
    - No firmar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    AUC0-24 h, Cmax, Tmax, Cmin and the correlation between AUC0-24 h and Cmin on the systematic exposure of 2 exteneded-realase oral formulations on stable phase
    AUC0-24 h, Cmax, Tmax, Cmin y correlación entre AUC0-24 h y Cmin en la exposición sistémica a dos formulaciones orales de tacrolimus de liberación prolongada en fase estacionaria.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 2 or 4 (depending where the pharmacokinetic is done)
    En la semana 2 o 4 (dependiendo cuando se realice la farmacocinética)
    E.5.2Secondary end point(s)
    - Incidence of acute rejection, by biopsy, during 6 months post-conversion
    - Percentage of patients with adverse events related to the investigational product (Envarsus®)
    - Percentage of patients with adverse event related to Envarus that causes hospitalization during 6 months post-conversion
    - Incidencia de rechazo agudo por biopsia durante los 6 meses post-conversión.
    - Porcentaje de pacientes con acontecimientos adversos relacionados con el tratamiento en estudio (Envarsus®).
    - Porcentaje de pacientes que presentan acontecimientos adversos con Envarsus® que causan hospitalización durante los 6 meses post-conversión.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 6 months post -conversion
    - during all trial
    - 6 months post -conversion
    - 6 meses post -conversion
    - durante todo el estudio
    - 6 meses post -conversion
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) 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 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) Yes
    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
    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 months1
    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 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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 be able to continue with the treatment (Envarsus) once finish the clinical trial, as judged by the investigator, if not the investigator will follow the SOC for this kind of patients.
    El paciente podrá continuar con el tratamiento (Envarsus) una vez finalice el ensayo clínico, a criterio del investigador. Si no el investigador seguirá la práctica clínica habitual para este tipo de pacientes.
    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 Decision2016-02-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-29
    P. End of Trial
    P.End of Trial StatusCompleted
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