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    Summary
    EudraCT Number:2017-000469-62
    Sponsor's Protocol Code Number:2017-000469-62
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2017-06-16
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2017-000469-62
    A.3Full title of the trial
    Pilot single‐arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV‐1‐infected solid organ transplant patients
    Ensayo clínico piloto de un brazo para evaluar la eficacia, las interacciones farmacocinéticas y la seguridad del dolutegravir más 2 inhibidores nucleósidos de la Transcriptasa Inversa (NRTIs en su siglas en inglés) en pacientes trasplantados de órganos sólidos infectados por el VIH-1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pilot single‐arm clinical trial to evaluate the efficacy, PK interactions and safety of dolutegravir plus 2 NRTIs in HIV‐1‐infected solid organ transplant patients.
    DGT-SOT
    Ensayo clínico piloto de un brazo para evaluar la eficacia, las interacciones farmacocinéticas y la seguridad del dolutegravir más 2 inhibidores nucleósidos de la Transcriptasa Inversa (NRTIs en su siglas en inglés) en pacientes trasplantados de órganos sólidos infectados por el VIH-1. DGT-SOT
    A.3.2Name or abbreviated title of the trial where available
    DTG-SOT
    DTG-SOT
    A.4.1Sponsor's protocol code number2017-000469-62
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    B.1.3.4CountrySpain
    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 supportViiV Healthcare
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU Clinic (clinical Trial Unit)
    B.5.2Functional name of contact pointCTU
    B.5.3 Address:
    B.5.3.1Street Addressroselló
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754009838
    B.5.5Fax number+34932279877
    B.5.6E-mailacruceta@clinic.ub.es
    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 Triumeq®
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex 36 TW8 9GS Reino Unido
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTriumeq 50 mg/600 mg/300 mg comprimidos recubiertos con película dolutegravir/abacavir/lamivudina
    D.3.4Pharmaceutical form Coated 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 INNdolutegravir
    D.3.9.3Other descriptive nameDOLUTEGRAVIR
    D.3.9.4EV Substance CodeSUB35122
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNabacavir
    D.3.9.1CAS number 188062-50-2
    D.3.9.3Other descriptive nameABACAVIR SULFATE
    D.3.9.4EV Substance CodeSUB00231MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.3Other descriptive namelamivudine
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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 Yes
    D.2.1.1.1Trade name Dolutegravir 50 mg
    D.2.1.1.2Name of the Marketing Authorisation holderVIIV Healtcare. 980 Great West road. Brentford. Middlesex. Reino Unido
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTivicay 50 mg
    D.3.4Pharmaceutical form 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 INNdolutegravir
    D.3.9.3Other descriptive nameDOLUTEGRAVIR SODIUM
    D.3.9.4EV Substance CodeSUB130591
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Yes
    D.2.1.1.1Trade name 200 mg de emtricitabina y 245 mg de tenofovir disoproxil (equivalente a 300 mg de tenofovir disoproxil fumarato ó 136 mg de tenofovir).
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited Cambridge CB1 6GT Reino Unido
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameTruvada comprimidos recubiertos con película.
    D.3.4Pharmaceutical form 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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenofovir
    D.3.9.3Other descriptive nameTENOFOVIR DISOPROXIL
    D.3.9.4EV Substance CodeSUB20643
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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
    HIV-1 infected solid organ transplant patients
    pacientes trasplantados de órganos sólidos infectados por el VIH-1.
    E.1.1.1Medical condition in easily understood language
    HIV-1 infected solid organ transplant patients
    pacientes trasplantados de órganos sólidos infectados por el VIH-1.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10057925
    E.1.2Term Transplant evaluation
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aims of this study are to obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients To provide proof of principle data that DTG plus 2 NUCs is safe and effective in HIV‐infected SOT recipients.
    1: Obtener datos farmacocinéticos sobre las interacciones entre DTG y fármacos inmunosupresores (ciclosporina A, Tacrolimus, Syrolimus y ácido micofenólico) en receptores de trasplante de órgano sólido (SOT en sus siglas inglesas) y
    2. Proporcionar una prueba de concepto de que la pauta antirretroviral de DTG más 2 NNRTIs es segura y eficaz en paciente infectados por el VIH receptores de un SOT.
    E.2.2Secondary objectives of the trial
    1. To assess the development of viral resistance in subjects experiencing virological failure;

    2. To assess the changes in CD4+ cell count in peripheral blood;

    3. To assess the changes in lipid profile (triglycerides, total, LDL‐ and HDL‐cholesterol);

    4. To assess renal function in HIV SOT patients.
    1. Evaluar el desarrollo de resistencia viral en sujetos con fracaso virológico;
    2. Evaluar los cambios en el recuento de células CD4 + en la sangre periférica;
    3. Evaluar los cambios en el perfil lipídico (triglicéridos, colesterol total, LDL y HDL);
    4. Evaluar la función renal en pacientes con SOT VIH.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) studies v1.0_ 08_may_2017
    The aim is to detect any possible drug‐drug interactions between DTG and widely‐used immunosuppressant drugs (IS) (Cyclosporine A , Tacrolimus, Syrolimus and Mycophenolic acid).
    estudio Farmacocinético PK) studies v1.0_ 08_may_2017
    El objetivo es detectar cualquier posible interacción fármaco-fármaco entre DTG y fármacos inmunosupresores ampliamente utilizados (ciclosporina A, tacrolimus, sirolimus y ácido micofenólico).
    E.3Principal inclusion criteria
    1. HIV patients >18 years old who provide signed and dated informed consent;
    2. Males and females;
    3. SOT recipients (heart, liver or kidney);
    4. On stable ART for ≥6 months preceding the screening visit;
    5. Plasma HIV RNA <50 cop/ml for 12 months (2 tests separated by at least 12 months with no viral load >50 between determinations);
    6. Absence of major reverse transcriptase or integrase gene mutations affecting study drug efficacy by proviral DNA sequencing
    1. Pacientes VIH> 18 años de edad que proporcionan consentimiento informado firmado y fechado;
    2. Hombres y mujeres;
    3. receptores de SOT (corazón, hígado o riñón);
    4. Sobre ART estable durante ≥6 meses antes de la visita de cribado;
    5. ARN del VIH plasmático <50 cop / ml durante 12 meses (2 pruebas separadas por al menos 12 meses sin carga viral> 50 entre determinaciones);
    6. Ausencia de importantes mutaciones del gen de la transcriptasa inversa o de la integrasa que afectan la eficacia del fármaco del estudio mediante la secuenciación del ADN proviral.
    E.4Principal exclusion criteria
    1. HIV patients who have stopped ART due to virological failure;
    2. HIV patients who require treatment with DTG contraindicated medications;
    3. History or presence of an allergy or intolerance to the study drug;
    4. Active opportunistic infection;
    5. Neoplasms requiring chemotherapy.
    6. Pregnancy or breast feeding or planned pregnancy during the study period
    7. Any other contraindication to study drugs.
    1. Pacientes con VIH que han dejado el TAR debido a fallo virológico;
    2. Pacientes con VIH que requieren tratamiento con medicamentos contraindicados por DTG;
    3. Antecedentes o presencia de una alergia o intolerancia al fármaco del estudio;
    4. Infección oportunista activa;
    5. Neoplasias que requieren quimioterapia;
    6. Cualquier otra contraindicación para estudiar drogas.
    7. Mujeres embarazadas o intención de embarazo durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    1. To obtain pharmacokinetic data on interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid) in SOT recipients;

    2. To provide proof of principle data that DTG plus 2 NRTIs is safe and effective in HIV‐infected SOT recipients. (numer AES, SAEs related treatment and CD4 cels
    1: Obtener datos farmacocinéticos sobre las interacciones entre DTG y fármacos inmunosupresores (ciclosporina A, Tacrolimus, Syrolimus y ácido micofenólico) en receptores de trasplante de órgano sólido (SOT en sus siglas inglesas) y
    2. Proporcionar una prueba de concepto de que la pauta antirretroviral de DTG más 2 NNRTIs es segura y eficaz en paciente infectados por el VIH receptores de un SOT.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Interactions between DTG and immunosuppressant drugs (Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid)

    Susars, SAEs, Death
    Intweracciones del dolutegravir con tratamientos inmuodepresores ( Cyclosporine A, Tacrolimus, Syrolimus and Mycophenolic acid)

    Susars, SAEs, muerte
    E.5.2Secondary end point(s)
    To assess the development of viral resistance in subjects experiencing virological failure;

    2. To assess the changes in CD4+ cell count in peripheral blood;w 48

    3. To assess the changes in lipid profile (triglycerides, total, LDL‐ and HDL‐cholesterol); w 48

    4. To assess renal function in HIV SOT patients.w 48
    . Evaluar el desarrollo de resistencia viral en sujetos con fracaso virológico;sem 48
    2. Evaluar los cambios en el recuento de células CD4 + en la sangre periférica;sem 48
    3. Evaluar los cambios en el perfil lipídico (triglicéridos, colesterol total, LDL y HDL);s 48
    4. Evaluar la función renal en pacientes con SOT VIH.sem 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    N/A
    N/A
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 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.8.3 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.8.5The 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 years2
    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 years2
    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: 20
    F.1.3Elderly (>=65 years) No
    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 state20
    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)
    none
    ninguno
    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 Decision2017-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-07-19
    P. End of Trial
    P.End of Trial StatusOngoing
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