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    Summary
    EudraCT Number:2017-003428-61
    Sponsor's Protocol Code Number:GS-US-380-4449
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-12-21
    Trial results View 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 number2017-003428-61
    A.3Full title of the trial
    A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically-Suppressed, HIV-1 Infected Subjects Aged ≥ 65 Years
    Estudio en fase IIIb, multicéntrico, abierto, para evaluar el cambio desde una pauta combinada de dosis fija de elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida o una pauta que contenga tenofovir disoproxil fumarato a una combinación de dosis fija de bictegravir/emtricitabina/tenofovir alafenamida en sujetos de edad avanzada, de ≥65 años de edad, infectados por VIH-1 con supresión virológica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study will test an experimental drug called B/F/TAF (bictegravir/emtricitabine/tenofovir alafenamide) fixed-dose combination (FDC) for the treatment of HIV-1 infection. The purpose of this study is to evaluate the effectiveness of switching to B/F/TAF FDC in HIV-1 infected adults aged ≥ 65 years who are virologically suppressed (HIV-1 RNA test <50 copies/mL) currently on elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide FDC or tenofovir disoproxil fumarate containing regimens.
    El estudio probará una combinación de dosis fija (CDF) del fármaco experimental,B/F/TAF (bictegravir/emtricitabina/tenofovir alafenamida) para el tratamiento de la infección por VIH-1. El objetivo es evaluar la efectividad del cambio a una CDF de B/F/TAF en adultos infectados por VIH-1 de ≥ 65 años de edad con supresión virológica (prueba de ARN del VIH-1 < 50 copias/ml) en tratamiento con CDF de elvitegravir/cobicist/emtricitabin/tenofovir alafenamida o pautas con tenofovir disoproxil fumarato.
    A.4.1Sponsor's protocol code numberGS-US-380-4449
    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 SponsorGilead Sciences, 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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+913789830
    B.5.5Fax number+913789841
    B.5.6E-mailclinical.trials@gilead.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code B/F/TAF
    D.3.4Pharmaceutical form Film-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 INNBICTEGRAVIR
    D.3.9.1CAS number 1611493-60-7
    D.3.9.2Current sponsor codeBIC
    D.3.9.4EV Substance CodeSUB182699
    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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor codeFTC
    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 ALAFENAMIDE
    D.3.9.1CAS number 379270-37-8
    D.3.9.2Current sponsor codeTAF
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Human Immunodeficiency Virus (HIV-1) Infection
    Infección por el Virus de la Inmunodeficiencia Humana (VIH-1)
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus (HIV-1) Infection
    Infección por el Virus de la Inmunodeficiencia Humana (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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the virologic efficacy of switching virologically suppressed subjects on an E/C/F/TAF FDC or TDF-containing regimen to B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week 24
    Caracterizar la eficacia virológica del cambio de E/C/F/TAF CDF o pauta que contiene TDF a B/F/TAF CDF en pacientes virológicamente suprimidos, definida por el ARN del VIH-1 <50 copias/ml en la semana 24.
    E.2.2Secondary objectives of the trial
    - To characterize the safety and tolerability of switching to B/F/TAF FDC from an E/C/F/TAF FDC or TDF-containing regimen
    - To characterize the virologic efficacy of switching to B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week 48
    - Caracterizar la seguridad y tolerabilidad del cambio a B/F/TAF CDF desde E/C/F/TAF CDF o pauta que contiene TDF.
    - Caracterizar la eficacia virológica del cambio a B/F/TAF CDF definida por el ARN del VIH-1 <50 copias/ml en la semana 48.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.
    1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    2) Age ≥ 65 years
    3) Currently receiving an ARV regimen of E/C/F/TAF FDC (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for ≥ 3 months
    4) Documented plasma HIV-1 RNA < 50 copies/mL during treatment with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously participated in GS-US-292-1826) for the last 2 visits preceding the Screening Visit (or undetectable HIV-1 RNA level according to the local assay being used if the limit of detection is ≥ 50 copies/mL)
    a) Unconfirmed virologic elevations of ≥ 50 copies/mL but < 400 copies/mL (transient detectable viremia, or “blip”) in the past are acceptable.
    b) If the lower limit of detection of the local HIV-1 RNA assay is < 50 copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot exceed 50 copies/mL on two consecutive HIV-1 RNA tests after < 50 copies/mL has been achieved.
    5) Plasma HIV-1 RNA levels < 50 copies/mL at Screening Visit
    6) Have no documented or suspected resistance to FTC, TFV, or BIC including, but not limited, to the reverse transcriptase resistance mutations K65R and M184V/I
    7) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
    8) Adequate renal function: eGFR ≥ 30 mL/min according to the Cockcroft-Gault formula for creatinine clearance
    9) Male subjects who are fertile and engage in heterosexual intercourse with women who are of child-bearing potential must agree to use protocol specified method(s) of contraception
    10) Male subjects must agree to refrain from sperm donation from first study drug dose until after the end of relevant systemic exposure
    11) Life expectancy >1 year
    Los sujetos deben cumplir todos los criterios de inclusión siguientes para ser considerados aptos para su participación en este estudio.
    1) Tener capacidad para comprender y firmar un formulario de consentimiento informado, que debe obtenerse antes de iniciar los procedimientos del estudio.
    2) Tener ≥ 65 años de edad.
    3) Estar recibiendo actualmente una pauta antirretroviral de CDF de E/C/F/TAF (o FTC/TDF + un tercer fármaco si participa actualmente o ha participado previamente en el GS-US-292-1826) durante ≥ 3 meses.
    4) ARN del VIH-1 en plasma documentado < 50 copias/ml durante el tratamiento con E/C/F/TAF (o FTC/TDF + tercer fármaco si está participando actualmente o participó previamente en el GS-US-292-1826) durante las 2 visitas previas a la visita de selección (o nivel de ARN del VIH-1 indetectable de acuerdo con el análisis local que se esté utilizando si el límite de detección es ≥ 50 copias/ml)
    a) Son aceptables las elevaciones virológicas no confirmadas de ≥ 50 copias/ml, pero < 400 copias/ml (viremia detectable temporal, o "blip") en el pasado.
    b) Si el límite inferior de detección del análisis local de ARN del VIH-1 es < 50 copias/ml (p. ej., < 20 copias/ml), el nivel de ARN del VIH-1 en plasma no puede exceder 50 copias/ml en dos análisis de ARN del VIH-1 consecutivas después de haber alcanzado < 50 copias/ml.
    5) Niveles plasmáticos de ARN del VIH-1 < 50 copias/ml en la visita de selección.
    6) No tener sospecha de resistencia o resistencia documentada a FTC, TFV o BIC incluida, entre otras, aquella a las mutaciones K65R y M184V/I de la transcriptasa inversa.
    7) ECG normal (o, si es anormal, determinado como no clínicamente significativo por el investigador)
    8) Función renal adecuada: TFGe ≥ 30 ml/min según la fórmula Cockcroft-Gault para el aclaramiento de la creatinina.
    9) Los sujetos fértiles de sexo masculino que mantengan relaciones heterosexuales con mujeres en edad fértil deben aceptar utilizar uno o varios métodos anticonceptivos especificados en el protocolo.
    10) Los sujetos de sexo masculino deben aceptar abstenerse de donar esperma desde la primera dosis de fármaco del estudio hasta después del final de la exposición sistémica relevante.
    11) Esperanza de vida > 1 año.
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
    1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
    2) Subjects experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)
    3) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids (e.g. prednisone doses > 10 mg daily or equivalent) during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
    4) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
    5) Malignancy within 5 years of screening other than cutaneous Kaposi’s sarcoma, completely resected non-melanoma skin cancer (basal cell carcinoma or non-invasive cutaneous squamous carcinoma), or completely resected carcinoma in-situ of the cervix (CIN 3) or anus
    (AIN 3). A prior malignancy treated with curative therapy and for which there has been no evidence of disease for at least five years prior to screening is allowed.
    6) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
    7) Participation in any other clinical trial, including observational studies, without prior approval from the Medical Monitor
    8) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
    9) Known hypersensitivity to B/F/TAF FDC tablets, their metabolites, or formulation excipient
    10) Subjects receiving ongoing therapy with any of the medications listed in the protocol, including drugs not to be used with BIC, FTC, and TAF
    11) Acute hepatitis in the 30 days prior to study entry
    12) Active tuberculosis infection
    No se inscribirá en este estudio a los sujetos que cumplan cualquiera de los siguientes criterios de exclusión:
    1) Una enfermedad oportunista indicativa de VIH en estadio 3 diagnosticada dentro de los 30 días previos a la selección.
    2) Sujetos que experimenten cirrosis descompensada (p. ej., ascitis, encefalopatía o varices hemorrágicas).
    3) Haber sido tratado con tratamientos inmunosupresores o agentes quimioterapéuticos dentro de los 3 meses previos a la selección del estudio, o que esperen recibir estos agentes o esteroides sistémicos (p. ej., dosis de prednisona > 10 mg al día o equivalente) durante el estudio (p. ej., corticoesteroides, inmunoglobulinas y otras terapias inmunológicas o basadas en citocinas).
    4) Consumo en la actualidad de alcohol o sustancias que el investigador estima podrían interferir con el cumplimiento del estudio por parte del paciente.
    5) Neoplasia maligna dentro de los 5 años previos de la selección distinta de sarcoma de Kaposi cutáneo, cáncer de piel no melanoma completamente resecado (carcinoma de células basales o carcinoma escamoso cutáneo no invasivo), o carcinoma in situ de cervix (CIN 3) o del ano completamente resecado (AIN 3). Se permite una neoplasia maligna anterior tratada con un tratamiento curativo y para la que no ha habido evidencia de enfermedad durante los últimos cinco años previos a la selección.
    6) Infecciones graves, activas (aparte de la infección por VIH-1) que requieran tratamiento antibiótico o antifúngico parenteral dentro de los 30 días previos al día 1.
    7) Participación en cualquier otro ensayo clínico, incluidos estudios observacionales, sin la aprobación previa del supervisor médico.
    8) Cualquier otra afección o tratamiento previo que, en opinión del investigador, haría que el sujeto no fuera apto para el estudio o no pudiera cumplir con los requisitos posológicos.
    9) Hipersensibilidad conocida a comprimidos de CDF de B/F/TAF, sus metabolitos o a los excipientes de formulación.
    10) Sujetos que reciben tratamiento continuado con cualquiera de los medicamentos recogidos en el protocolo, incluidos fármacos que no se vayan a usar con BIC, FTC y TAF.
    11) Hepatitis aguda en los 30 días previos a la entrada en el estudio.
    12) Infección activa por tuberculosis.
    E.5 End points
    E.5.1Primary end point(s)
    HIV-1 RNA <50 copies/mL at Week 24 - defined by the Food and Drug Administration (FDA) snapshot algorithm
    ARN del VIH-1 <50 copias/ml en la semana 24 - definido por el algoritmo snapshot de la Food and Drug Administration (FDA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    - Adverse events through Week 24
    - Adverse events through Week 48
    - HIV-1 RNA <50 copies/mL at Week 48 - defined by the Food and Drug Administration (FDA) snapshot algorithm
    - Acontecimientos adversos a la semana 24
    - Acontecimientos adversos a la semana 48
    - RNA del VIH-1 <50 copias/ml en la semana 48 - definido por el algoritmo snapshot de la Food and Drug Administration (FDA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 and Week 48
    Semana 24 y semana 48
    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 No
    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
    Patient reported outcomes
    Resultados informados del paciente
    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 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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
    Última visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    After a subject has completed/terminated their participation in the study, long-term care for the subject will remain the responsibility of their primary treating physician.
    Después de que el paciente termine su participación en el estudio su cuidado y seguimiento a largo plazo quedará bajo el criterio de su médico de cabecera.
    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 Decision2018-02-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-29
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