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    Summary
    EudraCT Number:2006-003868-59
    Sponsor's Protocol Code Number:WSA-CS-004
    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:2007-05-15
    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 number2006-003868-59
    A.3Full title of the trial
    A Phase III,Double Blind, Randomized Study to evaluate safety and efficacy of BAL8557 versus Voriconazole for primary treatment of Invasive Fungal Disease Caused by Aspergillus species or other filamentous fungi
    Studio di fase III, in doppio cieco, randomizzato per valutare la sicurezza e l'efficacia di BAL8557 verso Voriconazolo nel trattamento primario della malattia fungina invasiva causata dalla specie aspergillus o altri funghi filamentosi.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase III,Double Blind, Randomized Study to evaluate safety and efficacy of BAL8557 versus Voriconazole for primary treatment of Invasive Fungal Disease Caused by Aspergillus species or other filamentous fungi
    Studio di fase III, in doppio cieco, randomizzato per valutare la sicurezza e l`efficacia di BAL8557 verso Voriconazolo nel trattamento primario della malattia fungina invasiva causata dalla specie aspergillus o altri funghi filamentosi.
    A.3.2Name or abbreviated title of the trial where available
    WSA-CS-004
    A.4.1Sponsor's protocol code numberWSA-CS-004
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00412893
    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 SponsorASTELLAS PHARMA GLOBAL DEVELOPMENT, INC.
    B.1.3.4CountryUnited States
    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 supportAstellas
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationND
    B.5.2Functional name of contact pointND
    B.5.3 Address:
    B.5.3.1Street AddressND
    B.5.3.2Town/ cityND
    B.5.3.3Post codeND
    B.5.3.4CountryItaly
    B.5.4Telephone numberND
    B.5.5Fax numberND
    B.5.6E-mailND@ND.it
    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 nameIsavuconazolium sulfate
    D.3.2Product code BAL8557
    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 INNANTIMYCOTICS FOR SYSTEMIC USE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number186.3
    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 typeNon Applicabile
    D.IMP: 2
    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 nameIsavuconazolium sulfate
    D.3.2Product code BAL8557
    D.3.4Pharmaceutical form Powder for 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 INNANTIMYCOTICS FOR SYSTEMIC USE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number372.6
    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 typeNon Applicabile
    D.IMP: 3
    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 VFEND
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 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 INNVoriconazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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 typeNon Applicabile
    D.IMP: 4
    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 VFEND
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER ITALIA Srl
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 Powder for 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 INNVoriconazole
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.3Concentration number200
    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 typeNon Applicabile
    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 placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 2
    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
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboPowder for solution for injection
    D.8.4Route of administration of the placeboIntravenous use
    D.8 Placebo: 4
    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
    Invasive fungal disease caused by Aspergillus species or other filamentous fungi
    malattia fungina invasiva causata dalla specie aspergillus o altri funghi filamentosi.
    E.1.1.1Medical condition in easily understood language
    Invasive fungal disease caused by Aspergillus species or other filamentous fungi
    malattia fungina invasiva causata dalla specie aspergillus o altri funghi filamentosi.
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10003488
    E.1.2Term Aspergillosis
    E.1.2System Organ Class 10021881 - Infections and infestations
    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 overall outcome following primary treatment with BAL8557 versus VRC in patients with IFD caused by Aspergillus species or other filamentous fungi.
    - Confrontare l`esito complessivo conseguente a trattamento primario con BAL8557 verso VRC in pazienti con IFD causata da specie di Aspergillus o da altri funghi filamentosi.
    E.2.2Secondary objectives of the trial
    - To compare the effects of treatment on: - Overall outcome at EOT and Day 84 - Response in patients with mycologically confirmed pulmonary disease - Response in the subpopulations defined by the stratification variables - Mycological response - Survival rate. - To characterize the safety and tolerance of treatment with BAL8557 - To characterize the PK of BAL4815 and cleavage product BAL8278 in the relevant patient population.
    - Paragonare gli effetti di trattamento su:- Esito complessivo all`EOT e al giorno 84- Risposta in pazienti con malattia polmonare confermata per via micologica- Risposta nelle sottopopolazioni definite per mezzo delle variabili di stratificazione- Risposta micologica- Tasso di sopravvivenza.- Caratterizzare la sicurezza e tolleranza del trattamento con BAL8557- Caratterizzare la PK di BAL4815 e del prodotto di scissione BAL8278 nella popolazione di pazienti di interesse.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    PHARMACOGENETIC:
    Vers:4
    Date:2010/11/05
    Title:A Phase III, Double Blind, Randomized Study to Evaluate Safety and Efficacy of BAL8557 Versus Voriconazole for Primary Treatment of Invasive Fungal Disease Caused by Aspergillus Species or Other Filamentous Fungi
    Objectives:study genes that may have a correlation with the fungal infection or study the response to study drug

    FARMACOGENETICA:
    Vers:4
    Data:2010/11/05
    Titolo:Studio di fase III, in doppio cieco e randomizzato volto a valutare la sicurezza e l’efficacia di BAL8557 rispetto a voriconazolo per il trattamento primario di micosi invasiva causata dalla specie Aspergillus o da altri miceti filamentosi.
    Obiettivi:studiare i geni che potrebbero avere una correlazione con l`infezione micotica o studiare la risposta al farmaco in studio

    E.3Principal inclusion criteria
    `Patients and/or legally authorized representative(s), if applicable, who have been fully informed and who have given voluntary written informed consent `or `Patients unable to write and/or read but who fully understand the oral information given by the Investigator (or nominated representative) who have given oral informed consent witnessed in writing by an independent person. `Ability and willingness to comply with the protocol. `Male and female patients aged  18 years. `Female patients must be non-lactating and at no risk for pregnancy for one of the following reasons: `Postmenopausal for at least 1 year `Post hysterectomy and/or post bilateral ovariectomy `If of childbearing potential, having a negative urine or serum human chorionic gonadotropin (hCG) pregnancy test at the screening visit and be using a highly effective method of birth control throughout the course of the study. Reliable sexual abstinence throughout the course of the study is acceptable as a highly effective method of birth control for the purposes of this study. `Patients must have proven or probable IFD caused by Aspergillus species or other filamentous fungi as defined below. `Patients fulfilling the criteria for possible IFD as defined below will be eligible for enrollment; if, however, it is not possible to confirm IFD by culture, histology/ cytology or galactomannan (GM) antigen within the 7 days after the first administration of study medication they will be withdrawn from the study.
    `Pazienti e/o rappresentante(i) legalmente autorizzato(i), ove appropriato, i quali sono stati informati in maniera esauriente e che hanno fornito di propria volonta` un consenso informato scritto `o `Pazienti non in grado di scrivere e/o leggere ma che hanno compreso appieno le informazioni fornite oralmente dallo sperimentatore (o dal rappresentante incaricato), i quali hanno fornito un consenso informato orale attestato per iscritto da una persona indipendente. `Capacita` e volonta` di ottemperare al protocollo. `Pazienti di sesso maschile o femminile di eta`  18 anni. `I pazienti di sesso femminile non devono essere in fase di allattamento o per alcun motivo a rischio di gravidanza per una delle seguenti ragioni: `Postmenopausa da almeno 1 anno `Post isterectomia e/o post ovariectomia bilaterale `Se potenzialmente fertili, alla visita di screening devono presentare un test di gravidanza negativo per le gonadotropine corioniche umane (hCG) sulle urine o sul siero, e fare uso di un metodo altamente efficace di controllo delle nascite per tutta la durata della sperimentazione. Per gli scopi della presente ricerca, come metodo altamente efficace di controllo delle nascite si puo` accettare un`astinenza sessuale attendibile per tutta la durata dello studio. `I pazienti devono evidenziare IFD dimostrata o probabile causata da specie di Aspergillus o da altri funghi filamentosi come definito piu` avanti. `Saranno idonei al reclutamento i pazienti che avranno soddisfatto i criteri di una possibile IFD come definito piu` avanti; qualora, tuttavia, non sia possibile ottenere conferma della IFD mediante coltura, istologia/citologia o antigene galattomannano (GM) entro i 7 giorni successivi la prima somministrazione del farmaco in studio, essi saranno esclusi dalla sperimentazione.
    E.4Principal exclusion criteria
    1. Women who are pregnant or breastfeeding. 2. Known history of allergy, hypersensitivity to or any serious reaction to the azole class of antifungals or to any component of the study medication. 3. Patients for whom VRC is contra-indicated, including cardiovascular findings. 4. Patients at high risk for QT/QTc prolongation such as a family history of long QT syndrome or other known pro-arrythmic conditions. 5. Evidence of moderate to severe hepatic or renal dysfunction with any of the following abnormal laboratory parameters at the screening visit: - Total bilirubin  3 times the upper limit of normal (ULN) - Alanine transaminase (ALT) or aspartate transaminase (AST)  5 times ULN - Calculated creatinine clearance (CLcr) < 50 mL/minutes. 6. Concomitant use of sirolimus, efavirenz ritonavir, astemizole, cisapride, rifampicin, rifabutin, ergot alkaloids, long acting barbiturates, carbamazepine, pimozide, quinidine, neostigmine or terfenadine, in the 5 days prior to first administration of study drug. 7. Patients with any other invasive fungal infection other than Aspergillus species or other filamentous fungi and patients with Zygomycetes or Scedosporium prolificans infection not expected to respond to voriconazole treatment. 8. Patients with either chronic aspergillosis, aspergilloma, or ABPA. 9. Microbiological (e.g. virological) findings or other potential conditions that are temporally related and suggest a different etiology of the clinical features. 10. Patients who have received more than 4 cumulative days of systemic antifungal therapy other than fluconazole within 7 days prior to the first administration of study medication. 11. Advanced human immunodeficiency virus infection with CD4 count < 200 or acquired immunodeficiency syndrome defining condition, body weight < 40 kg. 12. Any known or suspected condition of the patient that may jeopardize adherence to the protocol requirements or impede the accurate measurement of efficacy (e.g. neutropenia not expected to resolve, patients with endocarditis, osteomyelitis, meningitis, uncontrolled malignancy with life expectancy of less than 30 days). 13. Patients with a concomitant medical condition that, in the opinion of the investigator, may be an unacceptable additional risk to the patient should he/she participate in the study. 14. Patients previously enrolled in this study. 15. Treatment with any investigational drug in blinded phase III or any phase I and phase II trials within 30 days prior to the first administration of study medication. 16. Patients who are unlikely to survive longer than 5 days or patients on mechanical ventilation.
    1. Donne in stato di gravidanza o in fase di allattamento. 2. Storia nota di allergia, ipersensibilita` alla, o una qualunque reazione seria alla, classe di antifungini degli azoli, oppure a uno qualunque dei componenti del farmaco in studio. 3. Pazienti per i quali il VRC e` controindicato, compresi i riscontri a livello cardio-vascolare. 4. Pazienti ad alto rischio di prolungamento del QT/QTc, come ad esempio una storia familiare di sindrome del QT lungo, oppure altre condizioni pro-aritmiche note. 5. Evidenze di disfunzione epatica o renale da moderata a severa, con anomalie a carico di uno qualunque dei seguenti parametri di laboratorio alla visita di screening: - Bilirubina totale  3 volte il limite superiore della norma (ULN) - Alanina transaminasi (ALT) o aspartato transaminasi (AST)  5 volte l`ULN - Clearance della creatinina (CLcr) calcolata &lt; 50 ml/minuti. 6. Impiego concomitante di sirolimus, efavirenz, ritonavir astemizolo, cisapride, rifampicina, rifabutina, alcaloidi dell`ergot, barbiturati ad azione prolungata, carbamazepina, pimozide, chinidina, neostigmina o terfenadina nei 5 giorni precedenti la prima somministrazione del farmaco in studio. 7. Pazienti colpiti da una qualsiasi altra infezione funigina invasiva diversa da quella dovuta a specie di Aspergillus o ad altri funghi filamentosi, e pazienti affetti da infezioni da Zygomycetes o da Scedosporium prolificans per i quali non ci si attende che rispondano alla terapia a base di voriconazolo. 8. Pazienti con aspergillosi cronica, aspergilloma o ABPA. 9. Riscontri microbiologici (per es., virologici) oppure altre condizioni potenziali temporaneamente correlati e indicativi di una differente eziologia delle caratteristiche cliniche. 10. Pazienti che hanno ricevuto piu` di 4 giorni cumulativi di terapia antifungina sistemica diversa dal fluconazolo entro i 7 precedenti alla prima somministrazione del farmaco in studio. 11. Infezione avanzata da virus dell`immunodeficienza umana con conte CD4 &lt; 200 oppure condizione che definisce una sindrome da immunodeficienza acquisita, peso corporeo &lt; 40 kg. 12. Qualunque condizione nota o sospetta del paziente che puo` mettere a rischio l`aderenza ai requisiti del protocollo oppure impedire l`accurata misurazione dell`efficacia (per es., neutropenia che non ci si aspetta si possa risolvere, pazienti con endocardite, osteomielite, meningite, neoplasia incontrollata con un`aspettativa di vita inferiore ai 30 giorni). 13. Pazienti con una condizione medica concomitante che, a giudizio dello sperimentatore, puo` rappresentare un rischio aggiuntivo inaccettabile per il paziente, qualora egli/ella dovesse prendere parte allo studio. 14. Pazienti precedentemente reclutati in questa sperimentazione. 15. Trattamento con un farmaco sperimentale qualsiasi in studi clinici di fase III in cieco oppure in qualsiasi studio di fase I e di fase II entro i 30 precedenti la prima somministrazione del farmaco in studio. 16. Pazienti per i quali la probabilita` di sopravvivenza oltre i 5 giorni sia scarsa o pazienti sottoposti a ventilazione meccanica.
    E.5 End points
    E.5.1Primary end point(s)
    All-cause mortality through Day 42
    tutte le cause di mortalità al giorno 42
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 42
    giorno 42
    E.5.2Secondary end point(s)
    na
    na
    E.5.2.1Timepoint(s) of evaluation of this end point
    na
    na
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 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 Information not present in EudraCT
    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 months18
    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 months18
    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 No
    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) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects unable to write and/or read but who fully understand the oral formulation given by the MD
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 95
    F.4.2.2In the whole clinical trial 360
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation NA
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2007-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-28
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