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    Summary
    EudraCT Number:2018-004885-32
    Sponsor's Protocol Code Number:DOBINeuro
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-20
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-004885-32
    A.3Full title of the trial
    THE EFFECTS OF SWITCHING FROM DOLUTEGRAVIR/LAMIVUDINE/ABACAVIR (D/L/A) TO BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (B/F/TAF) IN PATIENTS WITH SUPPRESSED VIRAL LOAD ON NEUROPSYCHIATRIC SIDE EFFECTS AND NEUROCOGNITIVE FUNCTION
    L’IMPATTO DEL PASSAGGIO DA DOLUTEGRAVIR/LAMIVUDINA/ABACAVIR (D/L/A) A BICTEGRAVIR/EMTRICITABINA/TENOFOVIR ALAFENAMIDE (B/F/TAF) NEI PAZIENTI IN TERAPIA ANTIRETROVIRALE CON HIVRNA SOPPRESSO SUGLI EVENTI AVVERSI NEUROPSICHIATRICI E SULLE FUNZIONI NEUROCOGNITIVE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    THE EFFECTS OF SWITCHING FROM DOLUTEGRAVIR/LAMIVUDINE/ABACAVIR (D/L/A) TO BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE (B/F/TAF) IN PATIENTS WITH SUPPRESSED VIRAL LOAD ON NEUROPSYCHIATRIC SIDE EFFECTS AND NEUROCOGNITIVE FUNCTION
    L’IMPATTO DEL PASSAGGIO DA DOLUTEGRAVIR/LAMIVUDINA/ABACAVIR (D/L/A) A BICTEGRAVIR/EMTRICITABINA/TENOFOVIR ALAFENAMIDE (B/F/TAF) NEI PAZIENTI IN TERAPIA ANTIRETROVIRALE CON HIVRNA SOPPRESSO SUGLI EVENTI AVVERSI NEUROPSICHIATRICI E SULLE FUNZIONI NEUROCOGNITIVE
    A.3.2Name or abbreviated title of the trial where available
    DOBINeuro
    DOBINeuro
    A.4.1Sponsor's protocol code numberDOBINeuro
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAZIENDA OSPEDALIERA UNIVERSITARIA SENESE
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda Ospedaliera Universitaria Senese
    B.5.2Functional name of contact pointUOC Malattie Infettive
    B.5.3 Address:
    B.5.3.1Street AddressViale Bracci 16
    B.5.3.2Town/ citySiena
    B.5.3.3Post code53100
    B.5.3.4CountryItaly
    B.5.4Telephone number0577586347
    B.5.5Fax number0577586155
    B.5.6E-mailbarbara.rossetti@ao-siena.toscana.it
    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 BIKTARVY
    D.2.1.1.2Name of the Marketing Authorisation holderGILEAD Sciences
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 namebictegravir/emtricitabina/tenofovir alafenamide
    D.3.2Product code [GS-9883-01]
    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 INNbictegravir/emtricitabina/tenofovir alafenamide
    D.3.9.2Current sponsor codebictegravir/emtricitabina/tenofovir alafenamide - GS-9883-01
    D.3.9.3Other descriptive namebictegravir/emtricitabina/tenofovir alafenamide
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 typeAntiretrovirale
    D.IMP: 2
    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.2.1.1.1Trade name TRIUMEQ
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTRIUMEQ
    D.3.2Product code [dolutegravir/abacavir/lamivudina]
    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/abacavir/lamivudina
    D.3.9.2Current sponsor codedolutegravir/abacavir/lamivudina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number49
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 typeantiretrovirale
    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 infection
    Infezione da HIV-1
    E.1.1.1Medical condition in easily understood language
    Human immunodeficiency virus type 1 (HIV-1) infection
    Infezione da virus dell'immunodeficienza umana acquisita 1 (HIV-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 determine frequence and to compare the severity of neuropsychiatric symptoms in HIV-infected patients treated with antiretroviral therapy with dolutegravir / lamivudine / abacavir switching to bictegravir / emtricitabine / tenofovir alafenamide or continue dolutegravir / lamivudine / abacavir after 3 months
    Determinare l’incidenza e confrontare la severità dei sintomi neuropsichiatrici nei pazienti con infezione da HIV virosoppressi in terapia antiretrovirale con dolutegravir/lamivudina/abacavir dopo 3 mesi dallo switch a bictegravir/emtricitabina/tenofovir alafenamide o dalla prosecuzione di dolutegravir/lamivudina/abacavir
    E.2.2Secondary objectives of the trial
    To compare between the two study arms:
    - severity and incidence of neuropsychiatric symptoms after 12 months in patients switching to bictegravir/emtricitabina/tenofovir alafenamide or continuing dolutegravir/lamivudina/abacavir
    - severity and incidence of neurocognitive impairment after 12 months in patients switching to bictegravir/emtricitabina/tenofovir alafenamide or continuing dolutegravir/lamivudina/abacavir
    - virological failure rates and resistance mutation selection
    - adverse effects rate
    - symptoms reported by patients, adherence, quality of life, satisfaction with treatment
    - to correlate the plasma concentrations of drugs with the severity of neuropsychiatric symptoms and with neurocognitive performances
    Confrontare tra i due bracci di studio:
    • severità ed incidenza dei sintomi neuropsichiatrici a 12 mesi dallo switch a bictegravir/emtricitabina/tenofovir alafenamide o dalla prosecuzione di dolutegravir/lamivudina/abacavir
    • severità ed incidenza della compromissione neurocognitiva a 12 mesi dallo switch a bictegravir/emtricitabina/tenofovir alafenamide o dalla prosecuzione di dolutegravir/lamivudina/abacavir
    • tasso di fallimento virologico e sviluppo di resistenze ai farmaci
    • tasso di effetti avversi
    • sintomi riferiti dai pazienti, aderenza, qualità della vita, soddisfazione al trattamento
    • correlare le concentrazioni plasmatiche dei farmaci con la severità dei sintomi neuropsichiatrici e con le performance neurocognitive
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age >18 years
    - HIV-1 infection
    - HIV RNA <50 copies/mL >12 months (including patients with 1 blip 50-200 cp/ml before screening not confirmed)
    - On treatment with dolutegravir/abacavir/lamivudine >6 months
    - Età superiore ai 18 anni
    - Infezione da HIV-1
    - HIV RNA< 50 copie/mL da almeno 12 mesi (ammesso prima dello screening 1 blip viremico tra 50 e 200 cp/ml non confermato da una successiva determinazione)
    - Terapia antiretrovirale con dolutegravir/abacavir/lamivudina in corso da almeno 6 mesi
    E.4Principal exclusion criteria
    - Previous AIDS events
    - Pregnancy or pregnancy plan
    - Decompensated cirrhosis (Child B or C)
    - Intake of alcohol, substances, other drugs that may affect neurocognitive performance
    - Necessity to receive drugs that may require dosing adjustment of dolutegravir or bictegravir
    - Certified diagnosis of major depression, psychosis, history of suicidal attempts
    - Treatment with antidepressants or antipsychotic drugs
    - History of virological failure with integrase inhibitors
    - Lack of knowledge of italian language
    - Impossibility to obtain informed written consent
    - HBsAg positivity
    - Estimated glomerular filtration rate by CK-EPI <50 ml/min per 1.73m2
    - Pregressi eventi AIDS-definenti
    - Donna in gravidanza o che pianifichi una gravidanza
    - Cirrosi scompensata (stadio Child B o C)
    - Uso di alcol, sostanze stupefacenti, altri farmaci che possono alterare le capacità neurocognitive
    - Necessità di assumere altri farmaci che possono richiedere aggiustamenti di dose di dolutegravir o bictegravir
    - Diagnosi accertata di depressione maggiore, psicosi, storia di tentativi di suicidio
    - Trattamento con farmaci antidepressivi o antipsicotici
    - Storia di fallimento virologico con inibitori dell’integrasi
    - Mancata conoscenza della lingua italiana
    - Incapacità di fornire consenso libero e informato
    - Positività HBsAg
    - Clearance creatinina sec CK-EPI <50 ml/min per 1.73m2
    E.5 End points
    E.5.1Primary end point(s)
    To verify difference in neuropsychiatric symptoms severity, using the Symptom Checklist-90-R, 3 months after switching to bictegravir or continuing dolutegravir (on treatment analysis).
    Differenza nella gravità dei sintomi neuropsichiatrici, usando la Checklist-90-R dei sintomi, 3 mesi dopo lo switch a bictegravir o continuando dolutegravir (analisi on-treatment).
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 mesi
    E.5.2Secondary end point(s)
    Difference in neuropsychiatric symptoms severity, each of the 10 symptoms analyzed separately using the Symptom Checklist-90-R, 3 and 12 months after switching to bictegravir or dolutegravir (on treatment analysis); Changes in self-reported symptoms, adherence and HR-QoL (using validated questionnaires) during the first year of follow up (ITT-exposed, using LOCF).; Difference in neuropsychiatric symptoms severity, using the Mini International Neuropsychiatric Interview Plus subscale for suicide risk, 3 and 12 months after switching to bictegravir or dolutegravir (on treatment analysis); Difference in neurocognitive performance, using a comprehensive and validated neuropsychological battery, 12 months after switching to bictegravir or dolutegravir (on treatment analysis); Correlation between symptoms (neuropsychiatric and other), drug exposure and HR-QoL during the first year of follow up.; Proportion of adverse events and serious adverse events and of patients discontinuing due to side effects in both arms; Proportion of virological failures and antiretrovirals resistance at virological failure; Differences in Treatment Satisfaction between arms as per specific questionnaire; Comparison of the inter-arm and intra-arm incidence of neurocognitive impairment (on the basis of Frascati criteria) at 12 months and neuropsychiatric symptoms (using the Symptom Checklist-90-R) at 3 (on treatment analysis) and 12 months (ITT-exposed, using LOCF)
    Differenza dei sintomi neuropsichiatrici tra i due bracci di trattamento, ciascuno dei 10 sintomi analizzati separatamente utilizzando la Checklist-90-R dei sintomi, 3 e 12 mesi dopo il passaggio a bictegravir o continuando dolutegravir (analisi on-treatment); Cambiamenti nei sintomi auto-riportati, aderenza e qualità della vita HR-Qol (utilizzando questionari validati) durante il primo anno di follow-up (ITT-esposti, utilizzando il criterio “Last Observation Carried Forward”); Differenza nella gravità dei sintomi neuropsichiatrici, utilizzando la sottoscala Mini International Neuropsychiatric Interview Plus per il rischio di suicidio, 3 e 12 mesi dopo il passaggio a bictegravir o continuando dolutegravir (analisi on-treatment); Differenza nelle prestazioni neurocognitive, utilizzando una batteria neuropsicologica completa e validata, 12 mesi dopo il passaggio a bictegravir o continuando dolutegravir (analisi on-treatment); correlazione tra sintomi (neuropsichiatrici e altro), livelli plasmatici di farmaci INSTI e qualità della vita durante il primo anno di follow-up (ITT-esposti, utilizzando il criterio “Last Observation Carried Forward”); Proporzione di eventi avversi ed eventi avversi severi e di pazienti che cessano la terapia a causa di effetti collaterali in entrambi i bracci; Percentuale di fallimenti virologici e di resistenze ai farmaci in caso di fallimento virologico; Differenze nella soddisfazione al trattamento tra i bracci come da questionario specifico; Confronto dell’incidenza nel braccio e tra bracci di danno neurocognitivo (sulla base dei criteri di Frascati) a 12 mesi e dei sintomi neuropsichiatrici (usando la Checklist-90-R dei sintomi) a 3 mesi (analisi on-treatment) e 12 mesi ( ITT esposti, utilizzando il criterio “Last Observation Carried Forward”)
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 and 12 months; 12 months; 3 and 12 months; 12 months; 12 months; 12 months; 12 months; 12; 3 and 12 months
    3 e 12 mesi; 12 mesi; 3 e 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12 mesi; 12; 3 e 12 mesi
    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 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 Yes
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned5
    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 Information not present in EudraCT
    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
    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 months20
    E.8.9.1In the Member State concerned days62
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months20
    E.8.9.2In all countries concerned by the trial days62
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women Yes
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    Continuation antiretroviral therapy
    Prosecuzione terapia farmacologica antiretrovirale
    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 Decision2019-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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