Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
  • clinical trials conducted outside the EU / EEA that are linked to European paediatric-medicine development.
  • Learn   more about the EU Clinical Trials Register   including the source of the information and the legal basis.


    The EU Clinical Trials Register currently displays   36094   clinical trials with a EudraCT protocol, of which   5933   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2010-019587-36
    Sponsor's Protocol Code Number:DSHNHL2009-1
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2011-04-19
    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 ConcernedGermany - BfArM
    A.2EudraCT number2010-019587-36
    A.3Full title of the trial
    Improvement of outcome and reduction of toxicity in elderly patients with CD20+ aggressive B-cell lymphoma by an optimised schedule of the monoclonal antibody rituximab, substitution of conventional by liposomal vincristine and FDG-PET based reduction of therapy in combination with vitamin D substitution
    A.3.2Name or abbreviated title of the trial where available
    OPTIMAL>60/DR.CHOP
    A.4.1Sponsor's protocol code numberDSHNHL2009-1
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01478542
    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 SponsorUniversität des Saarlandes
    B.1.3.4CountryGermany
    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 supportSpectrum Pharmaceuticals Inc.
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportF. Hofmann la Roche Ltd.
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAmgen GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversität des Saarlandes
    B.5.2Functional name of contact pointDSHNHL Central Study Office
    B.5.3 Address:
    B.5.3.1Street AddressKlinik für Innere Medizin I
    B.5.3.2Town/ cityHomburg (Saar)
    B.5.3.3Post code66421
    B.5.3.4CountryGermany
    B.5.4Telephone number+4968411615014
    B.5.5Fax number+4968411615015
    B.5.6E-maildshnhl@uks.eu
    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 nameMarqibo
    D.3.2Product code L01CA02
    D.3.4Pharmaceutical form Dispersion for infusion
    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 INNvincristine sulphate
    D.3.9.1CAS number N/A
    D.3.9.3Other descriptive namevincristine sulphate, liposomes
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number0,16
    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 typecytostatic drug
    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 Mabthera 100 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMabthera 100 mg
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNRituximab
    D.3.9.1CAS number 17472231
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Mabthera 500 mg
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRituximab (MabThera) 500 mg
    D.3.2Product code 45-2294
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNRituximab
    D.3.9.1CAS number 17472231
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 4
    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.2.5The 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 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 INNVINCRISTINE SULFATE
    D.3.9.1CAS number 2068-78-2
    D.3.9.4EV Substance CodeSUB05101MIG
    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 typecytostatic drug
    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
    Diffuse large B-cell lymphoma
    Diffus-großzelliges B-Zell-Lymphom
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10005329
    E.1.2Term Blood and lymphatic system disorders
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Patients with less favourable prognosis:
    1:To test whether progression-free survival (PFS) can be improved by substituting conventional by liposomal vincristine;
    2:To test whether PFS can be improved by 12 optimised applications instead of 8 2-week applications of rituximab
    Patients with favourable pro¬gnosis:
    3:Comparison of neurotoxicity of conventional and liposomal vincristine;
    4:Determination of PFS for the treatment strategy of reducing treatment in patients with negative FDG-PET after 4 x R-CHOP/CHLIP-14 (PET-4) and comparison with the corresponding patient population in RICOVER-60.

    bei Patienten mit weniger günstiger Prognose:1.Kann das progressionsfreie Überleben (PFS) durch Ersatz des konv.Vincristins (VCR) in der CHOP-Chemotherapie (CTX) durch lip.VCR verbessert werden? 2.lässt sich das PFS durch 12 optimierte Gaben des Antikörpers Rituximab (R) anstelle von 8 Gaben im Abstand von 2 Wochen in Kombination mit CHOP-14 oder CHLIP-14 CTX verbessern? b)bei Patienten mit günstiger Prognose:3.Vergleich der Neurotoxizität von konventionellem und liposomalem VCR 4.Bestimmung des PFS unter Reduktion der Therapie im Falle eines negativen FDG-PETnach 4x R-CHOP/CHLIP-14 und Vergleich mit der entsprechenden Patientenpopulation in RICOVER-60
    E.2.2Secondary objectives of the trial
    all
    -progn val of pre-treatm PET with conv CT/MRT
    -progn val of diff PET derived imaging biomarkers
    -PET-based indivi treatm strategy in OPTIMAL>60 with fixed treatm strategy in RICOVER>60
    -VCR-rel neurotox (Less Fav)&other tox (all)
    -therap efficacy vit D subst by comparing the first pat w/o vit D subst with pat with vit D subst
    -VCR rel neurotox &CNS events before/after A#4
    - Comp Cheson, Lugano&RECIL resp crit
    -Role of (M)TV
    -progn value of pre- & post-prephase treatm ECOG, of ref path and plasma biomarkers
    Fav pat:
    Determ, if adding 2xChemo+inv-node RX can compensate for assumed worse progn of pat with pos PET after 4xR-Chemo compared to pat with neg PET after 4xR-Chemo. Comp of PET pos pat who receive 2additional R-Chemo+RX with those who do not.
    Less Fav:
    Determ whether assumed worse progn of pat with bulk PET-pos after CTX compared to pat with PET-neg bulk after CTX can be compensated by RX to PET-pos bulk. Comp of pat with pos PET with/without RX
    alle: Vergl progn Wert prätherap PET mit konv CT/MRT
    -progn Wert. versch. PET abgeleiteter Biomarker
    -Vergl.PET-bas indiv Therapiestrat OPTIMAL-Studie mit fixer Therapiestrat RICOVER-60
    -VCR-ass Tox (Less Fav) u. sonst. Tox (alle)
    -therap Stellenwert VitD-Substit durch Vergl Pat ohne/mit VitD-Subst
    -VCR-ass. Tox, CNS-Events vor/nach A#4
    -Cheson-, Lugano-& Recil-Resp Krit
    -Rolle (M)TV
    -progn Wert ECOG vor/nach Vorphase, refpath Biomarker, ctDNA
    Fav: Prüfung, ob 2 zus Chemozyklen + inv-node RX die angenommene schlechtere Progn der Pat mit nach 4xR-Chemo pos PET im Vergl zur Progn von Pat mit neg PET kompensieren können. Vergl PET pos Pat, die zusätzlich 2x R-Chemo+RX erhalten mit PET pos Pat, die diese zusätzliche Therapie nicht erhalten
    Less Fav: Prüf ob RX die angenommene schlechtere Progn der Pat mit nach CTX PET-pos Bulk im Vergl zu Pat mit PET-neg Bulk kompensieren kann sowie Vergl Therapieergebnisse Pat mit posttherap pos PET, die eine/keine Strahlentherapie erhalten
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Cf. chapter 17 of the protocol:
    1)Special investigations: rituximab and vincristine pharmacokinetics
    Another goal of this study is the acquisition of pharmacokinetic data of the different rituximab application schedules as well as of vincristine.
    Therefore, rituximab pharmacokinetic data will be obtained from 20 male and 20 female patients with less favourable patients treated with bi-weekly and optimised rituximab, respectively (i. e. 80 patients in total), irrespective of the type of vincristine given.
    In addition, pharmacokinetic data of conventional and liposomal vincristine will be obtained in 5 male and 5 female patients with less favourable prognosis treated with conventional and liposomal vincristine, respectively in each of the 4 protocol arms (i.e. in 40 patients in total). ). The samples for pharmacokinetic data will be obtained 10 minutes before and 10 minutes after the end of the application of vincristine in cycle 1 . One additional sample will be obtained 12-24 hours after the application of vincristine in cycle 1 . At cycle 6 one sample will be taken 10 minutes before start of vincristine infusion. Even in case of any discontinuation of vincristine/Marqibo one serum sample should be taken before the application of chemotherapy in cycle 6. The schedule for the pharmacokinetic sampling must be strictly adhered to.
    These analyses will not be performed in patients receiving HD-MTX.
    Any pharmacokinetic studies will only be performed in centres with the necessary infrastructure after obtaining written informed consent from the patients.

    2) Circulating lymphoma-derived DNA
    Another goal of this study is the determinaton of circulating lymphoma derived DNA (ctDNA) in the blood of the patients randomised after Amendment #4. This “liquid biopsy” will be taken together with the necessary blood tests before each cycle of CHOP/CHLIP, at restaging after completion of therapy, and at each follow-up during the first two years after the end of treatment.
    Any “liquid biopsy” will only be performed in patients after obtaining a seperate written informed consent.
    E.3Principal inclusion criteria
    Elderly patients (61-80 years) with newly diagnosed aggressive CD20+ B-NHL. All risk groups with good general condition (ECOG 0-2) without majour accompanying diseases after patient's information and written patient's informed consent
    Patienten im Alter von 61 bis 80 Jahren mit neu diagnostiziertem CD20-positivem aggressivem Lymphom aller Risikogruppen in gutem Allgemeinzustand (ECOG 0-2) ohne wesentliche Begleiterkrankungen nach Aufklärung und schriftlicher Einverständniserklärung
    E.4Principal exclusion criteria
    Already initiated lymphoma therapy ; Serious accompanying disorder or impaired organ function; Platelets <75 000/mm3, leukocytes <2 500/mm3; Known hypersensitivity to the medications to be used; Known HIV-positivity; Chronic active hepatitis; Poor patient compliance; Simultaneous participation in other treatment studies or in another clinical trial; Prior chemo- or radiotherapy, long-term use of corticosteroids or anti-neoplastic drugs for previous disorder; CNS involvement of lymphoma; Persistent neuropathy grade ≥2 (unless due to lymphoma involvement) ;Pregnancy or breast-feeding women Persons depending on sponsor or investigator
    Persons from highly protected groups.


    Bereits begonnenen Behandlung des Lymphoms, schwerwiegende Begleiterkrankung; Thrombozyten <75 000/mm3, Leukozyten <2500/mm3, bekannte Allergie gegen eingesetzte Medikament, bekannte HIV-Positivität, chronisch aktive Hepatitis, schlechte Patienten-Compliance, gleichzeitige Teilnahme an anderen klinischen Prüfungen, frühere Chemo- oder Radiotherapie oder Langzeitgebrauch von Corticosteroiden oder Zytostatika bei früheren Erkrankungen, ZNS-Beteiligung des Lymphoms, Polyneuropathie Grad ≥2 (außer lymphomassoziiert), Schwangerschaft oder Stillzeit, vom Sponsor oder Prüfarzt abhängige Personen; sonstige unter besonderem Schutz stehende Personen
    E.5 End points
    E.5.1Primary end point(s)
    Progression free survival.
    PFS is defined by the time between the day of randomisation until one of the following events occurs, whichever comes first:
    - Disease progression (PD)
    - Relapse after achieving CR
    - Progression after PR, NC or unknown
    - Death due to any cause.
    Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment
    E.5.1.1Timepoint(s) of evaluation of this end point
    during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.11 of the protocol).
    E.5.2Secondary end point(s)
    for efficacy: rate of complete remissions (CR rate), rate of partial responses (PR rate), rate of primary progressions, relapse rate, event-free survival (EFS) and overall survival (OS); rate and CTC grades of polyneuropathy.
    Prognostic value of the FDG-PET derived imaging biomarkers for lymphoma load: SUV (standardized uptake value), SUR (standardized uptake ratio), metabolic tumor volume (MTV), total lesion glycolysis (TLG), SUR-derived TLG (TLGSUR).
    Different reference pathology biomarkers from tumor tissue and circulating tumor DNA in the plasma
    E.5.2.1Timepoint(s) of evaluation of this end point
    for efficacy and FDG-PET derived Imaging biomarkers: during the restagings and the follow-up assessments as planned in the protocol (cf. chapter 8.11 of the protocol). The incidence and rates of polyneuropathy will additionally be assessed before each cycle of chemotherapy. Assessment of ctDNA: before each cycle of CHOP/CHLIP, at restaging after completion of therapy, and at each follow-up during the first two years after the end of treatment.
    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 Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Vergleichspräparat für Marqibo (liposomales Vincristin) ist konventionelles Vincristin
    E.8.2.4Number of treatment arms in the trial6
    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 concerned130
    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 Yes
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1152
    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 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 state1152
    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 Decision2011-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
    European Medicines Agency © 1995-2019 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    Legal notice
    EMA HMA