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    Summary
    EudraCT Number:2009-013407-66
    Sponsor's Protocol Code Number:AV-951-09-901
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-01-14
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2009-013407-66
    A.3Full title of the trial
    A Rollover Protocol to Allow Continued Access to Tivozanib Hydrochloride (AV-951) for Subjects Enrolled in Other Tivozanib Hydrochloride Protocols
    Kiterjesztett vizsgálati terv mindazon betegek további tivozanib hidroklorid (AV-951) készítménnyel történő ellátására, akik különböző vizsgálatokban tivozanib hidrokloridot kaptak
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to continue giving Tivozanib to subject participating in other studies with Tivozanib
    Vizsgálati terv mindazon betegek további tivozanib hidroklorid készítménnyel történő ellátására, akik különböző vizsgálatokban tivozanib hidrokloridot kaptak
    A.4.1Sponsor's protocol code numberAV-951-09-901
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01369433
    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 SponsorAVEO Pharmaceuticals, 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 supportAVEO Pharmaceuticals, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAVEO Pharmaceuticals, Inc.
    B.5.2Functional name of contact pointBarbara Fielman
    B.5.3 Address:
    B.5.3.1Street Address650 East Kendall Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02142
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1617299-5902
    B.5.5Fax number+1617995-4827
    B.5.6E-mailbfielman@aveooncology.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 No
    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/3/10/747
    D.3 Description of the IMP
    D.3.1Product nameTivozanib hydrochloride
    D.3.2Product code AV-951
    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 INN Tivozanib Hydrochloride
    D.3.9.1CAS number 475108-18-0
    D.3.9.2Current sponsor codeAV-951
    D.3.9.3Other descriptive nameTIVOZANIB
    D.3.9.4EV Substance CodeSUB64411
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    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: 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 Yes
    D.2.5.1Orphan drug designation numberEU/3/10/747
    D.3 Description of the IMP
    D.3.1Product nameTivozanib hydrochloride
    D.3.2Product code AV-951
    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 INN Tivozanib Hydrochloride
    D.3.9.1CAS number 475108-18-0
    D.3.9.2Current sponsor codeAV-951
    D.3.9.3Other descriptive nameTIVOZANIB
    D.3.9.4EV Substance CodeSUB64411
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    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: 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 No
    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/3/10/747
    D.3 Description of the IMP
    D.3.1Product nameTivozanib hydrochloride
    D.3.2Product code AV-951
    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 INN Tivozanib Hydrochloride
    D.3.9.1CAS number 475108-18-0
    D.3.9.2Current sponsor codeAV-951
    D.3.9.3Other descriptive nameTIVOZANIB
    D.3.9.4EV Substance CodeSUB64411
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.5
    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
    Renal Cell Carcinoma Stage III,
    Renal Cell Carcinoma Stage IV,
    Metastatic Renal Cell Carcinoma
    vese karcinóma
    E.1.1.1Medical condition in easily understood language
    renal cancer
    vese daganat
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10038400
    E.1.2Term Renal carcinoma stage IV
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10038399
    E.1.2Term Renal carcinoma stage III
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10050076
    E.1.2Term Metastatic renal carcinoma
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To allow continued access to tivozanib for subjects who have participated in other tivozanib (monotherapy or combination) protocols, who are tolerating study drug and displaying clinical benefit and to provide access to tivozanib hydrochloride as a treatment option for subjects who received sorafenib in study AV-951-09-902 and were tolerating sorafenib and displaying clinical benefit at the time of study termination.
    •További hozzáférést biztosítani a tivozanib hidrokloridhoz olyan betegeknek, akik más tivozanib hidrokloriddal történő klinikai vizsgálatokban már részt vettek (monoterápiaként, kombinációban, vagy másik karról átlépve kapták a szert), jól tolerálták a vizsgálati készítményt, és klinikailag értékelhető javulást mutattak.
    •Kezelési lehetőségként biztosítani a tivozanib hidrokloridot olyan betegeknek, akik az AV-951-09-902 vizsgálatban sorafenibet kaptak, azt jól tolerálták, és a vizsgálat befejezésekor klinikailag értékelhető javulást mutattak
    E.2.2Secondary objectives of the trial
    To assess long-term safety and tolerability in subjects who continue on tivozanib
    Kiértékelni olyan betegek hosszútávon tapasztalt nemkívánatos eseményeit és súlyos nemkívánatos eseményeit, akik tovább szedik a tivozanib hidrokloridot.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subject must have received tivozanib hydrochloride while enrolled in another protocol, must be tolerating study drug and must currently display clinical benefit. The length of time that a subject must be on the parent protocol before rolling over to this protocol will be dictated by the parent protocol.
    a. Subjects who received tivozanib hydrochloride at any time while on parent protocol AV-951-12-205, regardless of sequence, may enroll if they tolerated and displayed clinical benefit while receiving tivozanib hydrochloride.
    b. Subjects receiving sorafenib in Study AV-951-09-902 who were tolerating sorafenib and displaying clinical benefit at the time of study termination may initiate tivozanib hydrochloride as a treatment option.
    2. If female and of childbearing potential, documentation of negative pregnancy test prior to enrollment (i.e. before the first dose of tivozanib hydrochloride in this protocol).
    3. Ability to give written informed consent.
    1.Egy másik protokollban bevont betegként tivozanib hidrokloridot kellett kapnia, jól kell tolerálnia a vizsgálati készítményt és jelenleg is klinikailag értékelhető javulást kell mutatnia. Hogy mennyi ideje kellett kapnia a betegnek a készítményt, mielőtt átkerülhet ebbe a vizsgálatba, az az eredeti vizsgálati protokolltól függ.
    a.Bevonhatók azok a vizsgálati alanyok, akiket eredetileg az AV-951-12-205 vizsgálatba vontak be és annak keretében bármikor kaptak tivozanib hidrokloridot függetlenül az egymásutániságtól, azt jól tolerálták és a tivozanib hidroklorid kezelés hatására klinikailag értékelhető javulást értek el.
    b.Azok a betegek, akik az AV-951-09-902 vizsgálatban sorafenibet kaptak, és azt jól tolerálták, illetve klinikailag értékelhető javulást értek el, a vizsgálat lezárásakor kezdeményezhetik, hogy kezelésként tivozanib hidrokloridot kaphassanak.
    2.Ha a beteg fogamzóképes nő, akkor a bevonás előtt dokumentumokkal köteles igazolni, hogy a terhességi tesztje negatív (azaz még mielőtt megkapná ebben a klinikai vizsgálatban az első tivozanib hidroklorid dózisát).
    3.A beteg képes írásos beleegyező nyilatkozatot adni.
    E.4Principal exclusion criteria
    1. > 4 weeks since discontinuation of study drug treatment on a previous AVEO-sponsored clinical trial.
    a. For subjects initiating tivozanib hydrochloride (ie receiving sorafenib and demonstrating tolerability and clinical benefit on Study AV-951-09-902 at the time of study termination), > 4 weeks since last dose of sorafenib, unless discussed with Sponsor.
    2. If female, pregnant or lactating.
    3. Sexually active male and pre-menopausal female subjects (and their partners) unless they agree to use adequate contraceptive measures, while on study and for 45 days after the last dose of study drug. All fertile male and female subjects (and their partners) must agree to use a highly effective method of contraception. Highly effective birth control includes (a) IUD plus one barrier method; (b) oral, implantable or injectable contraceptive plus one barrier method; or (c) 2 barrier methods. Effective barrier methods are male or female condoms, diaphragms, and spermicides (creams or gels that contain a chemical to kill sperm).
    4. Uncontrolled hypertension: systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg documented on 2 consecutive measurements taken at least 24 hours apart.
    5. Unhealed wounds (including active peptic ulcers).
    6. Serious/active infection or infection requiring parenteral antibiotics.
    7. Life-threatening illness or organ system dysfunction compromising safety evaluation.
    8. Psychiatric disorder, altered mental status precluding informed consent or necessary testing.
    9. Inability to comply with protocol requirements.
    1.Akiknél több mint 4 hét telt el azóta, hogy egy korábbi AVEO szponzorált vizsgálatban abbamaradt a vizsgálati készítménnyel folytatott kezelés
    a.Ha a beteg tivozanib hidrokloridra szeretne áttérni (azaz a beteg eddig sorafenibet kapott, azt jól tolerálta, és a vizsgálat befejezésekor klinikailag értékelhető javulást ért el az AV-951-09-902 vizsgálat zárásakor) és több mint 4 hét telt el az utolsó adag sorafenib óta, kivéve, ha a szponzorral történt megbeszélés után más döntés nem születik.
    2.Ha a nőbeteg terhes, vagy szoptat.
    3.A szexuálisan aktív férfiak és a pre-menopauzában levő nők (és partnereik), ha nem egyeznek bele, hogy megfelelő fogamzásgátlást alkalmazzanak mindaddig, míg részt vesznek a vizsgálatban és további 45 napig a vizsgálati készítmény utolsó adagjátkövetően. Minden nemzőképes férfi- és fogamzóképes nőbetegnek (és partnereiknek) vállalniuk kell, hogy igen megbízható fogamzásgátlást alkalmaznak. Ilyen megbízható fogamzásgátlás lehet a (a) méhen belüli eszköz (IUD) egy barrier módszerrel együtt; (b) szájon át szedett, implantált, vagy injekcióban adott fogamzásgátló egy barrier módszerrel együtt; vagy (c) egyidejűleg két barrier módszer. Hatékony barrier módszernek tekinthető a férfi, vagy női kondom, a pesszárium és spermicid krémek, vagy gélek, amelyek olyan vegyi anyagot tartalmaznak, amelyek elölik a spermiumokat.
    4.Kezeletlen magas vérnyomás: a szisztolés vérnyomás magasabb, mint 140 Hgmm, vagy a diasztolés vérnyomás több, mint 90 Hgmm két egymást követő mérés alkalmával, melyek között legalább 24 óra telt el .
    5.Nem gyógyuló sebek (ideértve az aktív gyomorfekélyt).
    6.Súlyos/aktív fertőzés, illetve parenterális antibiotikumot igénylő fertőzés.
    7.Életveszélyes betegség, vagy szervrendszeri működészavar, amely veszélyezteti a biztonságossági értékelést.
    8.Pszichiátriai rendellenesség, megváltozott elmeállapot, amely nem teszi lehetővé, hogy a beteg beleegyező nyilatkozatot adjon, vagy elvégezzék a szükséges teszteket
    9.A beteg képtelen betartani a vizsgálat terv előírásait.
    E.5 End points
    E.5.1Primary end point(s)
    Not Applicable
    E.5.1.1Timepoint(s) of evaluation of this end point
    Not Applicable
    E.5.2Secondary end point(s)
    Not Applicable
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    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 Yes
    E.6.13.1Other scope of the trial description
    allow continued access to tivozanib
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Canada
    Chile
    France
    Hungary
    India
    Poland
    Romania
    Russian Federation
    Serbia
    Ukraine
    United Kingdom
    United States
    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
    The end of the study is the last treatment visit of the last subject at the last site.
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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.1.1.1In 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: 1
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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 state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 82
    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)
    Subjects either experiencing unacceptable toxicities or with documented disease progression will be discontinued from further participation in this study.
    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 Decision2014-02-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-23
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    EU Clinical Trials Register Service Desk: https://servicedesk.ema.europa.eu
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