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    Summary
    EudraCT Number:2022-000617-13
    Sponsor's Protocol Code Number:TOR-VAX
    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:2022-03-04
    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 number2022-000617-13
    A.3Full title of the trial
    A prospective, randomized, controlled trial assessing the effect of conversion from Tacrolimus-antimetabolite to Tacrolimus-mTor-inhibitors based immunosuppression to booster SARS-CoV-2-specific seroconversion after a fourth dose of SARS-CoV-2 mRNA vaccine in unresponsive Solid Organ Transplant recipients
    Un estudio prospectivo, aleatorizado y controlado que evalúa el efecto de la conversión del antimetabolito de tacrolimus a la inmunosupresión basada en inhibidores de mTor + tacrolimus para reforzar la seroconversión específica del SARS-CoV-2 después de una cuarta dosis de la vacuna de ARNm del SARS-CoV-2 en pacientes receptores de trasplante de órgano sólido que no han respondido previamente.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    prospective, randomized, controlled study evaluating the effect of conversion from tacrolimus treatment to mTor inhibitor-based immunosuppression + tacrolimus to boost conversion to positive SARS-CoV-2 serology after a fourth dose of the vaccine of SARS-CoV-2 mRNA in solid organ transplant recipients who have not previously responded.
    Un estudio prospectivo, aleatorizado y controlado que evalúa el efecto de la conversión del tratamiento de tacrolimus a la inmunosupresión basada en inhibidores de mTor + tacrolimus para reforzar laconversión a positivo e la serología del SARS-CoV-2 después de una cuarta dosis de la vacuna de ARNm del SARS-CoV-2 en pacientes receptores de trasplante de órgano sólido que no han respondido previamente.
    A.3.2Name or abbreviated title of the trial where available
    TOR-VAX
    A.4.1Sponsor's protocol code numberTOR-VAX
    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 Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    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 supportFundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari Vall d'Hebron
    B.5.2Functional name of contact pointOriol Bestard
    B.5.3 Address:
    B.5.3.1Street AddressPasseig de la Vall d'Hebron, 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone numberSPAIN9327460006219
    B.5.5Fax numberSPAIN9327460006219
    B.5.6E-mailobestard@vhebron.net
    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 Rapamune
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    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.3.4Pharmaceutical form Oral solution
    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 INNSirolimus
    D.3.9.1CAS number 53123-88-9
    D.3.9.4EV Substance CodeSUB10537MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 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 Myfortic
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Farmacéutica, S.A.
    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.3.4Pharmaceutical 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 INNMYCOPHENOLIC ACID
    D.3.9.1CAS number 24280-93-1
    D.3.9.4EV Substance CodeSUB09098MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number180
    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 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 Cellcept
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical 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 INNmycophenolate mofetil
    D.3.9.1CAS number 128794-94-5
    D.3.9.3Other descriptive nameMYCOPHENOLATE MOFETIL
    D.3.9.4EV Substance CodeSUB03360MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    Seroconversion is evaluated after changing treatment from tacrolimus to tacrolimus + mTOR inhibitor in solid organ transplant patients who have not responded to the first three doses of the vaccine
    Se evalua la seroconversión tras el cambio de tratamiento de tacrolimus a tacrolimus + inhibidor de mTOR de los pacientes trasplantados de órgano sólido que no hayan respondido a las tres primeras dosis de la vacuna
    E.1.1.1Medical condition in easily understood language
    Se evalúa si los pacientes crean anticuerpos contra la covid tras cambiar el tratamiento a tacrolimus + imTOR en pacientes trasplantados que no han respondido a las tres primeras dosis de la vacuna
    It's evaluated if patients create antibodies against covid after changing treatment to tacrolimus + imTOR in transplant patients who have not responded to the first three doses of the vaccine
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10080575
    E.1.2Term Solid organ transplant
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objective of the study is to compare whether, after conversion from tacrolimus treatment to tacrolimus + mTor inhibitor, seroconversion is achieved with a fourth dose of the mRA vaccine against SARS-COV-2 in patients who have not responded to the first three dose
    El objetivo del estudio es comparar si tras la conversión del tratamiento de tacrolimus a tacrolimus + inhibidor de mTor se consigue la seroconversión con una cuarta dosis de la vacuna de mRA contra SARS-COV-2 de los pacientes que no han respondido a las tres primeras dosis
    E.2.2Secondary objectives of the trial
    • Differences in the percentage of patients with a positive memory T and B-cell immune responses assessed using functional immune assays one month after the 4th dose of the mRNA SARS-CoV-2 vaccines between groups.
    • Differences in the rates of patients with a diagnosis of COVID-19 one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups.
    • Rate of mTor-inhibitor discontinuation one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Estimated glomerular filtration rate one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Urine protein to creatinine ratio one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Rate of de novo anti-HLA antibodies one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Rate of biopsy-proven acute rejection one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Rate of adverse events one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    Diferencias en el porcentaje de pacientes con respuestas inmunitarias de células T y B de memoria positivas evaluadas mediante inmunoensayos funcionales un mes después de la 4ª dosis de las vacunas de ARNm SARS-CoV-2 entre grupos.
    • Diferencias en las tasas de pacientes con diagnóstico de COVID-19 al mes de la 4ª dosis de la vacuna mRNA SARS-CoV-2 entre grupos.
    • Tasa de suspensión del inhibidor de mTor un mes después de la 4.ª dosis de la vacuna mRNA SARS-CoV-2.
    • Tasa de eGFR un mes después de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    • Ratio de proteína/creatinina en orina un mes después de la cuarta dosis de la vacuna de ARNm SARS-CoV-2.
    • Tasa de anticuerpos anti-HLA de novo un mes después de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    • Tasa de rechazo agudo comprobado por biopsia al mes de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    • Tasa de eventos adversos al mes de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patient’s age ≥ 18 years
    2. Time of transplantation ≥ 1 year
    3. Negative or very weak (<143BAU/ml) serological immune response after 3 doses of an mRNA SARS-CoV-2 vaccine
    4. Stable renal function with an estimated GFR ≥ 40 mL/min/1.73 m2
    5. Urine protein to creatinine ratio < 0.8 g/g
    6. Written informed consent
    1. Edad del paciente ≥ 18 años
    2. Tiempo de trasplante ≥ 1 año
    3. Respuesta inmune serológica negativa o muy débil (<143BAU/ml) después de 3 dosis de una vacuna de ARNm SARS-CoV-2
    4. Función renal estable con FG estimado ≥ 40 ml/min/1,73 m2
    5. Proporción de proteína en orina a creatinina < 0,8 g/g
    6. Consentimiento informado por escrito
    E.4Principal exclusion criteria
    1. Previous diagnosis of T-cell mediated or antibody-mediated rejection
    2. Previous seroconversion after any SARS-CoV-2 vaccine.
    3. Previous COVID-19 infection
    4. Presence of HLA donor-specific antibodies
    5. Active cancer excluding non-melanoma skin cancer
    6. Pregnancy
    1. Diagnóstico previo de rechazo mediado por células T o mediado por anticuerpos
    2. Seroconversión previa después de cualquier vacuna contra el SARS-CoV-2.
    3. Infección previa por COVID-19
    4. Presencia de anticuerpos específicos del donante HLA
    5. Cáncer activo excluyendo el cáncer de piel no melanoma
    6. Embarazo
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the percentage of patients with a positive humoral immune response one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups.
    Diferencia en el porcentaje de pacientes con respuesta inmune humoral positiva al mes de la 4ª dosis de la vacuna mRNA SARS-CoV-2 entre grupos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Se hará una analítica previa a entrar en el estudio para confirmar la serología COVID negativa.
    Una semana después, y una vez confirmada la eligibilidad, se aleatoriazá al paciente a una rama de las dos ramas del tratamiento: Rama control o rama con cambio de tratamiento a tacrolimus + imtor
    Una vez asignada la rama de tratamiento, a los 30 dias se administrará la cuarta dosis de la vacuna de mRNA contra el SARS-COV-2. 30 dias depués de la administración se hará un control analítico a todos los pacientes para comprobar si ha habido seroconversión. Otros 30 dias después se volverá a repetir este control.
    An analysis will be done prior to entering the study to confirm the negative COVID serology.
    One week later, and once eligibility is confirmed, the patient will be randomized to one of two treatment arms: Control arm or arm with change to tacrolimus + imtor.
    Once the treatment arm has been assigned, the fourth dose of the mRNA vaccine against SARS-COV-2 will be administered 30 days later. 30 days after administration, all patients will undergo an analytical control to check whether there has been seroconversion. Another 30 days later, this control will be repeated.
    E.5.2Secondary end point(s)
    • Differences in the percentage of patients with a positive memory T and B-cell immune responses assessed using functional immune assays one month after the 4th dose of the mRNA SARS-CoV-2 vaccines between groups.
    • Differences in the rates of patients with a diagnosis of COVID-19 one month after the 4th dose of the mRNA SARS-CoV-2 vaccine between groups.
    • Rate of mTor-inhibitor discontinuation one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Estimated glomerular filtration rate one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Urine protein to creatinine ratio one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Rate of de novo anti-HLA antibodies one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Rate of biopsy-proven acute rejection one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    • Rate of adverse events one month after the 4th dose of the mRNA SARS-CoV-2 vaccine.
    Diferencias en el porcentaje de pacientes con respuestas inmunitarias de células T y B de memoria positivas evaluadas mediante inmunoensayos funcionales un mes después de la 4ª dosis de las vacunas de ARNm SARS-CoV-2 entre grupos.
    • Diferencias en las tasas de pacientes con diagnóstico de COVID-19 al mes de la 4ª dosis de la vacuna mRNA SARS-CoV-2 entre grupos.
    • Tasa de suspensión del inhibidor de mTor un mes después de la 4.ª dosis de la vacuna mRNA SARS-CoV-2.
    • Tasa de eGFR un mes después de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    • Ratio de proteína/creatinina en orina un mes después de la cuarta dosis de la vacuna de ARNm SARS-CoV-2.
    • Tasa de anticuerpos anti-HLA de novo un mes después de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    • Tasa de rechazo agudo comprobado por biopsia al mes de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    • Tasa de eventos adversos al mes de la 4ª dosis de la vacuna mRNA SARS-CoV-2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    An analysis will be done prior to entering the study to confirm the negative COVID serology.
    One week later, and once eligibility is confirmed, the patient will be randomized to one of the two treatment arms: Control arm or arm with change of treatment to tacrolimus + imtor. A week later, another control test will be done to check the drug levels in the blood.
    Once the treatment arm has been assigned, at 30 days, another analytical control will be carried out and the fourth dose of the mRNA vaccine against SARS-COV-2 will be administered. 30 days after administration, an analytical control will be carried out on all patients to check if there has been seroconversion and to check the rest of the secondary endpoints. Another 30 days later, this control will be repeated.
    Se hará una analítica previa a entrar en el estudio para confirmar la serología COVID negativa.
    Una semana después, y una vez confirmada la eligibilidad, se aleatoriazá al paciente a una rama de las dos ramas del tratamiento: Rama control o rama con cambio de tratamiento a tacrolimus + imtor. A la semana se hará otra analitica de control para comprobar los nieveles de fármaco en sangre.
    Una vez asignada la rama de tratamiento, a los 30 dias, se realizará otro control analítico y se administrará la cuarta dosis de la vacuna de mRNA contra el SARS-COV-2. 30 dias depués de la administración se hará un control analítico a todos los pacientes para comprobar si ha habido seroconversión y comprobar el resto de endpoints secundarios. Otros 30 dias después se volverá a repetir este control.
    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 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 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 concerned2
    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
    LVLP
    ultimo paciente ultima visita
    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 months8
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state50
    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
    nada
    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 Decision2022-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-06-09
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