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    Summary
    EudraCT Number:2012-000955-15
    Sponsor's Protocol Code Number:2012-101
    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:2012-09-26
    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 number2012-000955-15
    A.3Full title of the trial
    A phase IIa open-label, single arm, multi-center trial evaluating the safety of standard antiviral therapy (pegylated interferon and ribavirin) plus deferasirox in thalassemia patients with transfusion dependent iron overload and chronic hepatitis C
    Studio di fase IIa, multicentrico, in aperto, con un solo gruppo di trattamento per valutare la sicurezza della terapia antivirale standard (interferone pegilato e ribavirina) associata a deferasirox in pazienti talassemici con sovraccarico di ferro da dipendenza trasfusionale affetti da epatite cronica C.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the safety of standard antiviral therapy (pegylated interferon and ribavirin) plus deferasirox in thalassemia patients with transfusion dependent iron overload and chronic hepatitis C
    Valutare la sicurezza della terapia antivirale standard (interferone pegilato e ribavirina) associata a deferasirox in pazienti talassemici con sovraccarico di ferro da dipendenza trasfusionale affetti da epatite cronica C.
    A.4.1Sponsor's protocol code number2012-101
    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 OSPEDALIERA POLICLINICO DI MODENA
    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 supportAZIENDA OSPEDALIERA POLICLINICO DI MODENA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOPIS s.r.l.
    B.5.2Functional name of contact pointDipartimento Medico
    B.5.3 Address:
    B.5.3.1Street AddressVia Matteotti 10
    B.5.3.2Town/ cityDesio
    B.5.3.3Post code20832
    B.5.3.4CountryItaly
    B.5.4Telephone number0362 6331
    B.5.5Fax number0362 633633
    B.5.6E-mailosservatorio@opis.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 Yes
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2A
    D.3.9.1CAS number 198153-51-4
    D.3.9.4EV Substance CodeSUB16452MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 Yes
    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 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.2.1.2Country 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 and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGINTERFERON ALFA-2B
    D.3.9.1CAS number 215647-85-1
    D.3.9.4EV Substance CodeSUB12549MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1500
    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 Yes
    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: 3
    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.2.1.2Country 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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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 No
    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 EXJADE*28CPR DISP 125MG
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMA SpA
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/02/092
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Dispersible 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 INNDEFERASIROX
    D.3.9.1CAS number 201530-41-8
    D.3.9.4EV Substance CodeSUB21981
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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
    Thalassemia patients with transfusion dependent iron overload and chronic hepatitis C
    Sovraccarico di ferro da dipendenza trasfusionale in pazienti talassemici affetti da epatite cronica C.
    E.1.1.1Medical condition in easily understood language
    Thalassemia patients with transfusion dependent iron overload and chronic hepatitis C
    Sovraccarico di ferro da dipendenza trasfusionale in pazienti talassemici affetti da epatite cronica C.
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level PT
    E.1.2Classification code 10043388
    E.1.2Term Thalassaemia
    E.1.2System Organ Class 10010331 - Congenital, familial and genetic disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Safety profile of peg-IFN and RBV in combination with deferasirox, based upon drug administration and reporting of serious adverse events on the first 12 weeks of antiviral treatment.
    Profilo di sicurezza di peg-IFN e RBV in combinazione con deferasirox, in base alla somministrazione del farmaco e alla segnalazione di eventi avversi seri nelle prime 12 settimane di trattamento antivirale.
    E.2.2Secondary objectives of the trial
    - Safety evaluation for the concomitant use of peg-IFN /RBV + deferasirox, based upon drug administration and reporting of serious adverse events at 24 and 48 wks; - Safety of peg-IFN and RBV in combination with chelation therapy with deferasirox, evaluating all adverse events (AEs), serious adverse events (SAEs) and laboratory abnormalities during the 48 Wks of treatment; - Changes in serum ferritin, transfusion requirements, LIC and cardiac iron content by MRI T2*, cardiac function (LVEF, LVESV, LVEDV and LVMI); - Virological Evaluations: Rapid Virological Response, RVR (Undetectable serum HCV RNA after 4 weeks of therapy), Early Virological Response, EVR (Undetectable serum HCV RNA after 12 weeks of therapy).
    - Valutazione di sicurezza per l’utilizzo concomitante di peg-IFN /RBV + deferasirox,in base alla somministrazione del farmaco e alla segnalazione di eventi avversi seri alla settimana 24 e alla settimana 48;-Sicurezza di peg-IFN e RBV in combinazione con la terapia chelante con deferasirox,tramite la valutazione di tutti gli eventi avversi (AE),degli eventi avversi seri (SAE) e delle anormalità di laboratorio nel corso delle 48 settimane di trattamento;-Variazioni di ferritina sierica,fabbisogno trasfusionale,LIC e contenuto di ferro cardiaco tramite MRI T2*,funzionalità cardiaca (LVEF,LVESV,LVEDV e LVMI);- Valutazioni virologiche:Risposta virologica rapida (Rapid Virological Response,RVR) (HCV RNA sierico non rilevabile dopo 4 settimane di terapia),Risposta virologica precoce (EVR) (HCV RNA sierico non rilevabile dopo 12 settimane di terapia).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥18 years; - β-thalassemia patients with transfusional iron overload: Iron overload:  20 units (about 100 ml/kg) of packed red blood cells received or when there is evidence from clinical monitoring that chronic iron overload is present (e.g. serum ferritin >1,000 µg/l); - Patients previously treated with any iron chelator (deferoxamine, deferiprone, deferasirox) and already receiving deferasirox at least two months before study start; - Cardiac MRI T2* >15msec; - LVEF at MRI ≥56%; -Adult male or female patients with diagnosis of chronic hepatitis C (HCV-RNA and HCV-antibodies positivity), any genotype, candidate to antiviral therapy; - Women of childbearing potential should use a valid contraceptive method; - Written Informed Consent obtained from the patient.
    - Età ≥18 anni; - Pazienti affetti da β-talassemia con sovraccarico di ferro trasfusionale: - Sovraccarico di ferro:  20 unità (circa 100 ml/kg) di emazie concentrate ricevute o quando vi è evidenza dal monitoraggio clinico che è presente il sovraccarico cronico di ferro (ad es. ferritina sierica &gt;1,000 µg/l); - Pazienti precedentemente trattati con qualsiasi terapia ferrochelante (deferoxamina, deferiprone, deferasirox) e che ricevono già deferasirox da almeno due mesi prima dell’inizio dello studio; -MRI T2* cardiaco &gt; 15 msec; - LVEF all’MRI ≥56%; - Pazienti adulti di sesso maschile e femminile con diagnosi di epatite cronica C (positività agli anticorpi HCV-RNA e HCV-), di qualsiasi genotipo, candidati alla terapia antivirale; - Le donne potenzialmente fertili devono utilizzare un metodo contraccettivo valido; - Consenso informato scritto ottenuto dal paziente.
    E.4Principal exclusion criteria
    - Decompensated cirrhosis;- Patients with ALT levels > 10 x ULN;- White-cell count less than 3000 per cubic millimeter;- Neutrophil count less than 1500 per cubic millimeter;- Platelet count less than 90,000 per cubic millimeter;- TSH alterations (with or without HRT);- HBsAg positive / HIV seropositivity (Elisa or Western blot);- HCC or focal hepatic lesions at the ultrasound examination in the 3 months before; - Alcohol abuse (more than 25 grams per day); - Prior organ or HSC transplantation; -Severe psychiatric conditions; - Seizure disorder or other conditions contraindicated to receive peg-IFN and/or Ribavirin, such as history or clinical evidence of chronic pulmonary disease, history of immunologically mediated disease, history of ophthalmologic disorders, history of organ transplantation other than cornea or hair transplant, history of known coagulopathy including hemophilia; - Active cardiovascular disease (heart failure or malignant arrhythmias); - Poorly controlled diabetes mellitus; - Patients with considerable impaired gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral deferasirox (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection); - History of galactose intolerance, lactase deficiency or glucose-galactose malabsorption; - History of hypersensitivity to any of the study drugs or to drugs with similar chemical structure; - Received concomitant systemic antibiotics, antifungals or antivirals for the treatment of active infection within 14 days prior to baseline; - Received systemic corticosteroids (prednisone equivalent of >10mg/day) within 14 days prior to baseline; - Active inflammatory disease that may interfere with accurate measurement of serum ferritin; - History of clinically relevant ocular or ear disorders; - Patients with psychiatric or addictive disorders which prevent them from giving their informed consent or undergoing any of the treatment options or patients unwilling or unable to comply with the protocol; - History of malignancy of any organ system, treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin; - Pregnant or nursing (lactating) women are not eligible to participate in the study; - Patients participating in another clinical trial or receiving an investigational drug; - History of non-compliance with medical regimens or patients who are considered potentially unreliable and/or not cooperative, unwilling or unable to comply with the protocol.
    - Cirrosi scompensata;- Pazienti con livelli di ALT &gt; 10 x ULN;- Conta leucocitaria inferiore a 3000 per millimetro cubo;- Conta dei neutrofili inferiore a 1500 per millimetro cubo;- Conta piastrinica inferiore a 90000 per millimetro cubo;- Alterazioni del TSH (con o senza HRT);- Positività ad HBsAg /sieropositività ad HIV (test Elisa o Western blot);- HCC o lesioni focali epatiche all’esame ecografico nei tre mesi precedenti;- Abuso di alcol (più di 25 grammi al giorno);- Precedente trapianto d’organo o di HSC;- Condizioni psichiatriche gravi;- Disordine convulsivo o altre condizioni che costituiscono una controindicazione a ricevere peg-IFN e/o ribavirina, quali anamnesi o evidenza clinica di malattia polmonare cronica, anamnesi di malattia immunologicamente mediata, anamnesi di disordini oftalmologici, anamnesi di trapianto d’organo fatta eccezione per il trapianto di cornea o di capelli, anamnesi di coagulopatia nota compresa emofilia;- Malattia cardiovascolare attiva (insufficienza cardiaca o aritmie maligne);- Diabete mellito scarsamente controllato;- Pazienti con funzionalità gastrointestinale deteriorata in modo considerevole o patologie gastrointestinali che potrebbero alterare in modo significativo l’assorbimento di deferasirox per via orale (ad esempio, malattie ulcerative, nausea non controllata, vomito, diarrea, sindrome da malassorbimento o resezione dell’intestino tenue);- Anamnesi di intolleranza al galattosio, deficit di lattasi o malassorbimento di glucosio-galattosio;- Anamnesi di ipersensibilità ad uno qualsiasi dei farmaci in studio o a farmaci con struttura chimica simile;- Pazienti che hanno ricevuto antibiotici sistemici, antifunginei o antivirali per il trattamento dell’infezione attiva nei 14 giorni precedenti il basale;- Pazienti che hanno ricevuto corticosteroidi sistemici (prednisone equivalente di &gt;10mg/giorno) nei 14 giorni precedenti il basale;- Patologia infiammatoria attiva che potrebbe interferire con la misurazione accurata della ferritina sierica;- Anamnesi di rilevanti disordini oculari o dell’orecchio;- Pazienti con disordini psichiatrici o legati a dipendenze che impedirebbero loro di dare il proprio consenso informato o di sottoporsi ad una qualsiasi delle opzioni di trattamento o pazienti non disponibili o non in grado di aderire al protocollo;- Anamnesi di patologia maligna di qualsiasi sistema d’organo, trattata o non trattata, nei 5 anni precedenti indipendentemente da evidenza di recidiva locale o metastasi, ad eccezione del carcinoma basocellulare cutaneo localizzato;- Donne in gravidanza o allattamento;- Pazienti che partecipano ad un altro studio sperimentale o che ricevono un altro farmaco sperimentale;- Storia di scarsa aderenza a regimi medici o pazienti che sono considerati potenzialmente non affidabili e/o non collaborativi, non disponibili o non in grado di aderire al protocollo.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence, type and severity of SAEs in first 12 weeks.
    Incidenza, tipo e severità dei SAE nelle prime 12 settimane.
    E.5.1.1Timepoint(s) of evaluation of this end point
    First 12 weeks
    Prime 12 settimane
    E.5.2Secondary end point(s)
    - Incidence, type and severity of SAEs at 24 and 48 weeks; - Incidence, type and severity of AEs, renal, hepatic, biochemistry and hematologic parameters and SAEs during 48 weeks; -Efficacy of chelation therapy: changes in serum ferritin, transfusion requirements, at 12, 24 and 48 weeks and LIC and cardiac iron content by MRI T2* at 48 weeks, cardiac function (LVEF, LVESV, LVEDV and LVMI) at 48 weeks; - HCV RNA assessment after 4 and 12 weeks of therapy.
    - Incidenza, tipo e severità dei SAE alla settimana 24 e alla settimana 48; - Incidenza, tipo e severità degli AE, parametri renali, epatici, biochimici ed ematologici e SAE nel corso di 48 settimane; - Efficacia della terapia chelante: variazioni di ferritina sierica, fabbisogno trasfusionale alle settimane 12, 24 e 48 e LIC e contenuto di ferro cardiaco tramite MRI T2* alle 48 settimane, funzionalità cardiaca (LVEF, LVESV, LVEDV and LVMI) alle 48 settimane; - Valutazione HCV RNA dopo 4 e 12 settimane di terapia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - at 24 and 48 weeks; - during 48 weeks; - at 12, 24 ,48 weeks and at 48 weeks; - after 4 and 12 weeks.
    - alla settimana 24 e alla settimana 48; - nel corso delle 48 settimane; - alla settimana 12, 24 e 48 e alle 48 settimane; - dopo 4 e 12 settimane.
    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 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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    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 years0
    E.8.9.1In the Member State concerned months19
    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.1.1Number 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.1.2.1Number of subjects for this age range: 39
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state42
    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)
    Chelation therapy
    Terapia chelante
    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 Decision2012-10-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-04
    P. End of Trial
    P.End of Trial StatusCompleted
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