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    Summary
    EudraCT Number:2021-006779-41
    Sponsor's Protocol Code Number:CAR-GR
    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:2022-07-22
    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 number2021-006779-41
    A.3Full title of the trial
    HIV-1 RNA suppression and drug concentrations in semen, cervicovaginal fluid and rectum in HIV-1 infected individuals receiving intramuscular long-acting cabotegravir plus rilpivirine (“CAR-GR Study)
    Supresión de ARN VIH-1 y Concentraciones de fármacos en semen, fluido cervicovaginal y fluido rectal en personas infectadas por VIH-1 en tratamiento con Cabotegravir plus Rilpivirina de acción prolongada por vía intramuscular (Estudio CAR GR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HIV-1 RNA suppression and drug concentrations in semen, cervicovaginal fluid and rectum in HIV-1 infected individuals receiving intramuscular long-acting cabotegravir plus rilpivirine (“CAR-GR Study)
    Supresión de ARN VIH-1 y Concentraciones de fármacos en semen, fluido cervicovaginal y fluido rectal en personas infectadas por VIH-1 en tratamiento con Cabotegravir plus Rilpivirina de acción prolongada por vía intramuscular (Estudio CAR GR)
    A.3.2Name or abbreviated title of the trial where available
    CAR-GR
    CAR-GR
    A.4.1Sponsor's protocol code numberCAR-GR
    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 SponsorFUNDACIÓN FLS DE LUCHA CONTRA EL SIDA, LAS ENFERMEDADES INFECCIOSAS Y LA PROMOCIÓN DE LA SALUD Y LA CIENCIA
    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 supportFUNDACIÓN FLS DE LUCHA CONTRA EL SIDA in colaboration with ViiV Healthcare
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari de Bellvitge
    B.5.2Functional name of contact pointArkaitz Imaz Vacas
    B.5.3 Address:
    B.5.3.1Street AddressC/ Feixa Llarga, s/n
    B.5.3.2Town/ cityL'Hospitalet de Llobregat
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932607667
    B.5.5Fax number+34932607669
    B.5.6E-mailaimaz@bellvitgehospital.cat
    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 nameCabotegravir
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCabotegravir
    D.3.9.3Other descriptive nameGSK1265744
    D.3.9.4EV Substance CodeSUB179611
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRilpivirine
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRilpivirine
    D.3.9.1CAS number 500287-72-9
    D.3.9.4EV Substance CodeSUB31456
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCabotegravir
    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 INNCabotegravir Sodium
    D.3.9.3Other descriptive nameCABOTEGRAVIR SODIUM
    D.3.9.4EV Substance CodeSUB198499
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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: 4
    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 nameRilpivirine
    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 INNRilpivirine hydrochloride
    D.3.9.1CAS number 700361-47-3
    D.3.9.3Other descriptive nameRilpivirine hydrochloride
    D.3.9.4EV Substance CodeSUB31460
    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
    HIV infected individuals
    Individuos infectados por VIH
    E.1.1.1Medical condition in easily understood language
    HIV infected individuals
    Individuos infectados por VIH
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    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 Cabotegravir and Rilpivirine concentrations in seminal plasma, rectal tissue and cervicovaginal fluid (CVF) in male and female individuals living with HIV receiving IM Cabotegravir and Rilpivirine LA every 2 months.
    - Determinar las concentraciones de Cabotegravir y Rilpivirina en semen, fluido rectal y fluido cervicovaginal en hombres y mujeres que viven con VIH recibiendo Cabotegravir y Rilpivirina LA intramuscular cada dos meses.
    E.2.2Secondary objectives of the trial
    - To evaluate HIV-1 RNA suppression in seminal plasma, rectal fluid and CVF in male and female individuals living with HIV receiving IM Cabotegravir and Rilpivirine LA every 2 months.
    Evaluar la supresión de ARN-VIH-1 en semen, fluido rectal y fluido cervicovaginal en hombres y mujeres que viven VIH recibiendo Cabotegravir y Rilpivirina LA intramuscular cada dos meses
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.
    2. Male and female HIV-1 infected adult patients receiving standard triple therapy with 2 NRTIs (tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudine plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor) or a dual therapy (Dolutegravir/Lamivudine or Dolutegravir/Rilpivirine) during at least 6 months.
    3. Plasma HIV-1 RNA <50 copies/mL for at least 6 months at the Screening visit.
    4. Signed and dated written informed consent prior to inclusion.
    5. Female Subjects of Childbearing Potential* with a negative pregnancy test (validated and sensitive serum or urine b -human chorionic gonadotrophin [sensitivity <=25mIU/mL], at screening and baseline, must agree to use one of the following methods of contraception to avoid pregnancy:
    o Complete abstinence from penile-vaginal intercourse from at least 2 weeks prior to administration of Investigational Product and during the study intervention period [See Note 2 below];
    o Male partner sterilization confirmed prior to the female participant’s entry into the study, and provided this male is the sole partner for that participant
    o A contraceptive method that is highly effective** (with a failure rate of <1% per year).
    1. Individuos asintomáticos infectados por el VIH-1 ≥ 18 años de edad.
    2. Pacientes adultos infectados por el VIH-1, hombres y mujeres, que reciben triple terapia estándar con 2 NRTI (tenofovir disoproxilo fumarato/emtricitabina o abacavir/lamivudina más un inhibidor de la transcriptasa inversa no nucleósido, un inhibidor de la proteasa potenciado o un inhibidor de la integrasa) o una terapia dual (Dolutegravir/Lamivudina o Dolutegravir/Rilpivirina) durante al menos 6 meses.
    3. ARN del VIH-1 en plasma <50 copias/ml durante al menos 6 meses previos de la visita de selección.
    4. Consentimiento informado por escrito firmado y fechado antes de la inclusión.
    5. Sujetos femeninos en edad fértil* con una prueba de embarazo negativa (gonadotrofina coriónica humana β-gonadotrofina humana validada y sensible en suero u orina [sensibilidad <=25mIU/mL], en la selección y al inicio del estudio, y deben aceptar usar uno de los siguientes métodos anticonceptivos para evitar el embarazo:
    o Abstinencia total del coito pene-vagina desde al menos 2 semanas antes de la administración del Producto en investigación y durante el período de intervención del estudio
    o Esterilización de la pareja masculina confirmada antes de la entrada de la participante femenina en el estudio, y siempre que este hombre sea la única pareja de esa participante
    o Un método anticonceptivo que sea altamente efectivo (con una tasa de falla de <1% por año).
    E.4Principal exclusion criteria
    1. Evidence of hepatitis B virus infection based on results of testing at screening.
    2. Severe hepatic impairment (Grade 3-4 liver fibrosis, or cirrhosis).
    3. Individuals with chronic HCV infection who may be anticipated to need as new HCV therapy prior to the study endpoint.
    4. Ongoing malignancy
    5. Active opportunistic infection
    6. Resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
    7. Any verified Grade 4 laboratory abnormality
    8. Alanine Aminotransferase (ALT) ≥5 × Upper Limit Normal (ULN) or ALT ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin) over the last 6 months
    9. Severe renal impairment (estimated creatine clearance <30 mL/min per 1.73m2 via Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) Method).
    10. Females who are pregnant or breastfeeding or planning to become pregnant during the study period.
    11. Any pre-existing physical or mental condition (including substance use disorder) which, in the opinion of the investigators, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant.
    12. Any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to receive study medication.
    13. History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
    14. Current or anticipated need for chronic anti-coagulation or hereditary coagulation and platelet disorders such as haemophilia or Von Willebrand Disease.
    15. Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternative medication
    1. Evidencia de infección por el virus de la hepatitis B basada en los resultados de las pruebas de detección.
    2. Insuficiencia hepática grave (grado 3-4 de fibrosis hepática o cirrosis).
    3. Individuos con infección crónica por VHC que se puede anticipar que necesitarán una nueva terapia contra el VHC antes del punto final del estudio.
    4. Neoplasia maligna en curso
    5. Infección oportunista activa
    6. Resistencia a alguno de los antirretrovirales incluidos en el estudio o antecedentes de fracaso virológico con riesgo de selección de resistencia a alguno de los fármacos del estudio.
    7. Cualquier anormalidad de laboratorio de Grado 4 verificada
    8. Alanina aminotransferasa (ALT) ≥5 × Límite superior normal (LSN) o ALT ≥3xULN y bilirrubina ≥1,5xULN (con >35 % de bilirrubina directa) durante los últimos 6 meses
    9. Insuficiencia renal grave (depuración de creatina estimada <30 ml/min por 1,73 m2 a través del método de la Colaboración en Epidemiología y Enfermedad Renal Crónica (CKD-EPI)).
    10. Mujeres que estén embarazadas o amamantando o planeando quedar embarazadas durante el período de estudio.
    11. Cualquier condición física o mental preexistente (incluido el trastorno por uso de sustancias) que, en opinión de los investigadores, pueda interferir con la capacidad del participante para cumplir con el programa de dosificación y/o las evaluaciones del protocolo o que pueda comprometer la seguridad del partícipe.
    12. Cualquier condición que, en opinión del investigador, pueda interferir con la absorción, distribución, metabolismo o excreción de los medicamentos del estudio o impedir que el participante reciba la medicación del estudio.
    13. Historia o presencia de alergia o intolerancia a los medicamentos del estudio o sus componentes o medicamentos de su clase.
    14. Necesidad actual o anticipada de anticoagulación crónica o coagulación hereditaria y trastornos plaquetarios como la hemofilia o la enfermedad de Von Willebrand.
    15. Participantes que reciben cualquier medicamento prohibido y que no quieren o no pueden cambiar a un medicamento alternativo
    E.5 End points
    E.5.1Primary end point(s)
    - Total concentrations of Cabotegravir and Rilpivirine in seminal plasma and rectal tissue in male individuals; and in CVF in female individuals, 2 months after cabotegravir and rilpivirine LA IM dose (prior to next dose).
    - Concentraciones totales de Cabotegravir y Rilpivirina en plasma seminal y fluido rectal en individuos masculinos; y en fluido cervicovaginal en mujeres, 2 meses después de la dosis intramuscular de cabotegravir y rilpivirina de acción prolongada (antes de la siguiente dosis).
    E.5.1.1Timepoint(s) of evaluation of this end point
    7 months
    7 meses
    E.5.2Secondary end point(s)
    - Protein unbound fraction and estimated unbound concentrations of Cabotegravir and Rilpivirine in seminal plasma and rectal tissue in male individuals; and in CVF in female individuals, 2 months after cabotegravir and rilpivirine LA IM dose (prior to next dose).
    - HIV-1 RNA in seminal plasma and rectal tissue in male individuals; and in CVF in female individuals, 2 months after cabotegravir and rilpivirine LA IM dose.
    - Fracción de proteínas no unidas y concentraciones no unidas estimadas de Cabotegravir y Rilpivirina en plasma seminal y fluido rectal en individuos masculinos; y en fluido cervicovaginal en mujeres, 2 meses después de la dosis intramuscular de cabotegravir y rilpivirina de acción prolongada (antes de la siguiente dosis).
    - ARN del VIH-1 en plasma seminal y fluido rectal en individuos masculinos; y en fluido cervicovaginal en mujeres, 2 meses después de la dosis intramuscular de cabotegravir y rilpivirina de acción prolongada.
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 months
    2 meses
    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 No
    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
    Prevention
    Prevención
    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 Yes
    E.8.1.7.1Other trial design description
    Single group
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    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.1.2.1Number of subjects for this age range: 32
    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 state32
    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)
    The investigator will provide appropriate medical care both at the end of the study and in the event of premature discontinuation of the 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 Decision2022-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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