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    Summary
    EudraCT Number:2011-000130-11
    Sponsor's Protocol Code Number:EryDexFCTx1.0
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2012-03-05
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2011-000130-11
    A.3Full title of the trial
    Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation.
    Sperimentazione clinica in malattie rare: alternativa terapeutica all'uso di corticosteroidi orali nei pazienti con Fibrosi Cistica sottoposti a Trapianto di doppio polmone.
    A.4.1Sponsor's protocol code numberEryDexFCTx1.0
    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 SponsorAZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA
    B.1.3.4CountryItaly
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameDexamethasone sodium phosphate 250 mg/10 ml solution
    D.3.2Product code NA
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number500
    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 Yes
    D.3.11.13.1Other medicinal product typeDesametasone sodio fospato incapsulato in eritrociti umani
    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
    Double lung transplantation in patients with Cystic Fibrosis
    Trapianto di doppio polmone in pazienti affetti da Fibrosi Cistica
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10011763
    E.1.2Term Cystic fibrosis lung
    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 10025127
    E.1.2Term Lung transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Reducing the intake of oral steroids in patients with CF and underwent LTX. One wonders whether, compared to the classic dose of 25 mg / day for the first 3 months post-LTX and then 20 mg / day for 1 year post-LTX, low-dose dexamethasone (10 mg / month) encapsulated in RBCs are able to prevent acute/chronic rejection and reduce side effects associated with use of oral steroids
    Ridurre l’apporto di steroidi orali in pazienti affetti da FC e sottoposti a LTx. Ci si chiede se, rispetto al classico dosaggio di 25 mg/die per i primi 3 mesi post-LTx e successivamente 20 mg/die per il 1° anno post-LTx, basse dosi di Dexametasone (10 mg/mese) incapsulato nei RBCs siano in grado di evitare il rigetto acuto/cronico e di ridurre gli effetti secondari associati all’uso degli steroidi orali
    E.2.2Secondary objectives of the trial
    To assess the safety of the drug. Evaluate the reduction of pulmonary infections and / or invasive. Assess the reduction in the incidence of failure or possibly worsening osteoporosis / opsteopenia background to LTX. Assess the reduction of occurrence or worsening of diabetes may be non-existing at LTX. Evaluate the reduction in the incidence of hypertension. Assessing the quality of life.
    Valutare la sicurezza del farmaco. Valutare la riduzione delle infezioni polmonari e/o invasive. Valutare la riduzione dell’incidenza o eventualmente del mancato peggioramento dell’osteoporosi/opsteopenia preesistenti al LTx. Valutare la riduzione dell’insorgenza o eventualmente il mancato peggioramento del diabete preesistente al LTx. Valutare la riduzione dell’incidenza di ipertensione arteriosa. Valutare il miglioramento della qualita' della vita.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis documented FC • Double-lung transplantation at least 3 months • Age ≥ 12 years with no upper limits • Both sexes • Good compliance
    • Diagnosi documentata di FC • Trapianto di doppio polmone da almeno 3 mesi • Eta' ≥ 12 anni senza limiti superiori • Entrambi i sessi • Buona compliance
    E.4Principal exclusion criteria
    • Bulkholderia cepacia colonization and atypical mycobacteria Noncompliant • Subject to usual therapy • Pregnancy • Changes in therapy during the 30 days prior • episodes of acute rejection in the 30 days prior to the start of treatment, for which it was required intravenous or oral corticosteroid therapy • Patients with liver problems and / or kidney showing values of AST, ALT, or creatinine> 2 times the normal value
    • Colonizzazione da Bulkholderia cepacia e Mycobatteri atipici • Soggetto non compliante alla terapia usuale • Gravidanza • Variazioni di terapia nei 30 giorni antecedenti • Episodio di rigetto acuto nei 30 gg antecedenti all’inizio del trattamento, per cui e' stata necessaria terapia corticosteroidea endovenosa o per os • Pazienti con problemi epatici e/o renali che presentino valori di AST, ALT o creatinina &gt; 2 volte il valore normale
    E.5 End points
    E.5.1Primary end point(s)
    Check to see if low doses of Dex-21-P (10 mg / month) encapsulated in RBCs in patients with CF and underwent LTX compared to traditional oral dosing, are able to prevent acute rejection / chronic.
    Verificare se basse dosi di Dex-21-P (10 mg/mese) incapsulato nei RBCs in pazienti affetti da FC e sottoposti a LTx, rispetto al classico dosaggio per via orale, siano in grado di evitare il rigetto acuto/cronico.
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence Yes
    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 No
    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 Yes
    E.8.2.3.1Comparator description
    Stesso farmaco ad altro dosaggio assunto per bocca - Stesso farmaco ad altro dosaggio
    - same IMP used at different dosage
    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.8.4.1Number of sites anticipated in Member State concerned2
    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
    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 months9
    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: 0
    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.1.2Adults (18-64 years) Yes
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2012-03-05. Yes
    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
    popolazione pediatrica
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    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 Decision2011-07-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-07-21
    P. End of Trial
    P.End of Trial StatusOngoing
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