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    Summary
    EudraCT Number:2011-002459-33
    Sponsor's Protocol Code Number:MEN_BOC
    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:2011-09-21
    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 number2011-002459-33
    A.3Full title of the trial
    Boceprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Difficult-to-Treat Menopausal Women With Chronic Hepatitis C Genotype 1, either deemed Nonresponders to Peginterferon/Ribavirin or treatment-naives.
    Boceprevir in combinazione con Peginterferone Alfa-2b e Ribavirina nelle donne menopausali con epatite cronica C Genotipo 1 Difficult-to-Treat , Non responder a Peginterferone\Ribavirina o treatment-naives
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluating the effectiveness of therapy whith Boceprevir associated with antiviral therapy standard for chronic hepatitis viruc HCV in a population of menopausal women ganotipe one ever treated or not responsive to previous treatment
    Valutazione dell'efficacia della terapia con Boceprevir associato alla antivirale terapia standard per epatite cronica viruc da HCV in una popolazione di donne in menopausa ganotipo 1 mai trattate o non responsive a un precedente trattamento
    A.3.2Name or abbreviated title of the trial where available
    MEN_BOC
    MEN_BOC
    A.4.1Sponsor's protocol code numberMEN_BOC
    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 supportmerk
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationA.O.U. Policlinico di Modena - U.O. di Gastroenterologia
    B.5.2Functional name of contact pointAnna Ferrari study coordinator
    B.5.3 Address:
    B.5.3.1Street Addressvia del pozzo 71
    B.5.3.2Town/ citymodena
    B.5.3.3Post code41124
    B.5.3.4CountryItaly
    B.5.4Telephone number0594224023
    B.5.5Fax number0594224419
    B.5.6E-maila.ferrari1102@gmail.com
    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 vicrelis
    D.2.1.1.2Name of the Marketing Authorisation holderMerck & co
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 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 INNBoceprevir
    D.3.9.1CAS number 394730-60-0
    D.3.9.2Current sponsor codeSCH503034
    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 Yes
    D.3.11.13.1Other medicinal product typeinibitore delle proteasi
    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.2.1.1.1Trade name PEGINTRON*SC 1FL 80MCG+1 KIT
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH 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 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 IMPCutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNpegintron
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number120
    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.2.1.1.1Trade name REBETOL*168CPS 200MG
    D.2.1.1.2Name of the Marketing Authorisation holderSCHERING PLOUGH 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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Gastro-resistant 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 INNRIBAVIRIN
    D.3.9.1CAS number 36791-04-5
    D.3.9.4EV Substance CodeREBETOL
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number800 to 1200
    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
    menopausal women with chronic HCV genotype1, naive or previously treated her with standard antiviral therapy
    donne in menopausa con epatite cronica da virus HCV genotipo 1, naive o precedentemente trattae con terapia antivirale standard
    E.1.1.1Medical condition in easily understood language
    menopausal women with chronic HCV genotype1, naive or previously treated her with standard antiviral therapy
    donne in menopausa con epatite cronica da virus HCV genotipo 1, naive o precedentemente trattae con terapia antivirale standard
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    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 verify whether the addition of Boceprevir 800 mg TID to standard antiviral therapy with PEG IFN alfa 2b (1.5 µg/kg QW) plus Ribavirin (800-1400 mg/day) will determine at least a 25% improvement in SVR in the cohort of difficult-to-treat post-menopausal women with chronic hepatitis C (CHC) genotype 1 (either previous nonresponders to Peginterferon/Ribavirin (RBV) treatment or treatment naïves).
    Verificare se l'aggiunta di Boceprevir 800 mg TID alla terapia antivirale standard con PEG IFN alfa 2b (1,5 mcg / kg QW) + Ribavirina (800-1400 mg / die), determina un miglioramento di almeno il 25% della risposta virologica sostenuta (SVR) in una coorte ‘difficult to treat’ di donne post-menopausali con epatite cronica C (CHC) genotipo 1 (non responder a precedenti trattamenti con peginterferone e ribavirina (RBV) o naїve.
    E.2.2Secondary objectives of the trial
    na
    na
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Menopausal females with previously documented CHC infection, either (A) relapser or with a >2log10 IU/ml HCV RNA decrease at week 12 in a previous PEG IFN/Ribavirin treatment or (B) naives; • Subject must have a liver biopsy within the last 2 years with histology consistent with CHC and no other etiology. • Subjects with bridging fibrosis or cirrhosis must have an ultrasound within 6 months of the Screening Visit (or between Screening and Day 1) with no findings suspicious for hepatocellular carcinoma (HCC).
    • Donne in menopausa con infezione cronica da epatite C precedentemente documentata, relapser o che hanno presentato una riduzione &lt; 2 log10 UI / ml di RNA di HCV alla 12a settimana di un precedente trattamento con ribavirina/PEG IFN (A) o naïves(B); • Pazienti con biopsia epatica eseguita negli ultimi 2 anni con un’istologia compatibile con epatite cronica C e nessun’altra eziologia; • Pazienti con fibrosi a ponte o cirrosi con un’ecografia eseguita entro 6 mesi dalla visita di screening (o tra screening e 1 ° giorno di arruolamento) senza riscontro di lesioni sospette per carcinoma epatocellulare (HCC);
    E.4Principal exclusion criteria
    •For protocol (A), menopausal women with a null response (<2log10 IU/ml HCV RNA decrease at week 12) in a previous PEG IFN/Ribavirin treatment. •Coinfection with the human immunodeficiency virus (HIV) or hepatitis B virus (HBsAg positive). •Treatment with any investigational drug within 30 days of the randomization visit in this study. •Participation in any other clinical trial within 30 days of randomization or intention to participate in another clinical trial during participation in this study. •Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding varices, or hepatic encephalopathy. •Diabetic and/or hypertensive subjects with clinically significant ocular examination findings: retinopathy, cotton wool spots, optic nerve disorder, retinal hemorrhage, or any other clinically significant abnormality. •Pre-existing psychiatric condition(s). •Clinical diagnosis of substance abuse of the specified drugs within the specified timeframes. •Any known pre-existing medical condition that could interfere with the subject's participation in and completion of the study. •Evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible. •Subjects who had life-threatening serious adverse event (SAE) during screening period. •Protocol-specified hematologic, biochemical, and serologic criteria: Hemoglobin <12 g/dL for females and <13 g/dL for males; Neutrophils <1500/mm^3 (blacks: <1200/mm^3); Platelets <100,000/mm^3; Direct bilirubin >1.5 x upper limit of normal (ULN) •Serum albumin < lower limit of normal (LLN) •Thyroid-stimulating hormone (TSH) >1.2 x ULN or <0.8 x LLN of laboratory, with certain exceptions. •Serum creatinine >ULN of the laboratory reference. •Protocol-specified serum glucose concentrations. •Prothrombin time/partial thromboplastin time (PT/PTT) values >10% above laboratory reference range. •Anti-nuclear antibodies (ANA) >1:320.
    Per il protocollo (A), donne menopausali con una risposta nulla (riduzione &lt;2log10 UI/ml di HCV RNA alla 12a settimana) ad un precedente trattamento con PEG IFN/Ribavirina. • Co-infezione con il virus dell'immunodeficienza umana (HIV) o con il virus dell'epatite B (HBsAg positività). • Partecipazione a qualsiasi altra sperimentazione clinica entro 30 giorni dalla randomizzazione o intenzione di partecipare a un altro studio clinico durante la partecipazione a questo studio. •Evidenza di malattia epatica scompensata tra cui, ma non solo, ascite clinica presente o pregressa, sanguinamento da varici, o encefalopatia epatica. • Soggetti diabetici e / o ipertesi con riscontro all’esame oftamologico di: retinopatia, maculopatia, patologia del nervo ottico, emorragia retinica, o qualsiasi altra anomalia clinicamente significativa. • Condizione psichiatrica pre-esistente. • La diagnosi clinica di abuso di sostanze o uso di farmaci specifici entro i termini specificati. • Ogni condizione medica pre-esistente che possa interferire con la partecipazione del soggetto e il completamento dello studio. • riscontro e/o sospetto di malattia neoplastica o con storia di tumore maligno negli ultimi 5 anni (ad eccezione di carcinoma in situ adeguatamente trattati e carcinoma delle cellule basali della pelle). I soggetti in corso di valutazione per neoplasie maligne non sono arruolabili. • I soggetti che abbiano presentato evento avverso serio (SAE) con pericolo di vita durante il periodo di screening. • Criteri ematologici, biochimici e sierologici specificati nel protocollo con i seguenti valori: emoglobina &lt;12 g/dl per le donne e &lt;13 g/dL per i maschi; neutrofili &lt;1.500/mm ^ 3 (i neri: &lt;1200/mm ^ 3), piastrine &lt;100.000/mm ^ 3; bilirubina diretta&gt; 1,5 volte il limite superiore del valore normale (ULN). • albumina sierica &lt;al limite inferiore di normalità (LLN) • ormone tireostimolante (TSH)&gt;1.2 x ULN o &lt;0,8 x LLN di laboratorio, con alcune eccezioni. • Il valore di creatinina sierica &gt; ULN rispetto ai valori di riferimento del laboratorio. • Valori di glicemia specificati nel Protocollo. • Il tempo di protrombina / tempo di tromboplastina parziale (PT / PTT) con valori &gt;10% sopra il limite del laboratorio di riferimento. • Gli anticorpi antinucleo (ANA) &gt; 1:320.
    E.5 End points
    E.5.1Primary end point(s)
    To verify whether the addition of Boceprevir 800 mg TID to standard antiviral therapy with PEG IFN alfa 2b (1.5 µg/kg QW) plus Ribavirin (800-1400 mg/day) will determine at least a 25% improvement in SVR in the cohort of difficult-to-treat post-menopausal women with chronic hepatitis C (CHC) genotype 1 (either previous nonresponders to Peginterferon/Ribavirin (RBV) treatment or treatment naïves).
    Verificare se l'aggiunta di Boceprevir 800 mg TID alla terapia antivirale standard con PEG IFN alfa 2b (1,5 mcg / kg QW) + Ribavirina (800-1400 mg / die), determina un miglioramento di almeno il 25% della risposta virologica sostenuta (SVR) in una coorte ‘difficult to treat’ di donne post-menopausali con epatite cronica C (CHC) genotipo 1 (non responder a precedenti trattamenti con peginterferone e ribavirina (RBV) o naїve.
    E.5.1.1Timepoint(s) of evaluation of this end point
    72 week
    72 settimane
    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 No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    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) 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 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 Yes
    E.8.1.7.1Other trial design description
    I dati sopra riportati riguardano il braccio non responders a precedenti trattamenti
    na
    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 trial3
    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
    LVLP
    LVLP
    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 months36
    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 months0
    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.1.2.1Number of subjects for this age range: 170
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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)
    ABOUT 15 VISITS IN 6 MOUNTHS DURING THERAPY + 24 WEEKS OF FOLLOW UP
    circa 15 visite in 6 mesi durante la terapia + 24 settimane di follow-up
    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 Decision2011-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-13
    P. End of Trial
    P.End of Trial StatusOngoing
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