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    Summary
    EudraCT Number:2015-003389-10
    Sponsor's Protocol Code Number:HepaVac-101
    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:2017-04-26
    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 number2015-003389-10
    A.3Full title of the trial
    A phase I/II trial of IMA970A plus CV8102 following a single pre-vaccination infusion of cyclophosphamide in patients with very early, early and intermediate stage of hepatocellular carcinoma after any standard treatments
    Ensayo en fase I/II de IMA970A más CV8102 tras una única infusión prevacunal de ciclofosfamida en pacientes con carcinoma hepatocelular en estadio muy inicial, inicial o intermedio que han recibido tratamientos habituales de todo tipo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/II clinical study of IMA970A plus CV8102 and Cyclophosphamide for patients with liver cancer
    Ensayo en fase I/II de IMA970A más CV8102 y ciclofosfamida en pacientes con cáncer de higado
    A.4.1Sponsor's protocol code numberHepaVac-101
    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 SponsorIstituto Nazionale Tumori G. "Pascale"
    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 supportEU Seventh Framework Program EU FP7
    B.4.2CountryEuropean Union
    B.4.1Name of organisation providing supportIstituto Nazionale Tumori G. "Pascale"
    B.4.2CountryItaly
    B.4.1Name of organisation providing supportImmatics Biotechnologies GmbH
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportCurevac AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSERMES PLANIFICACION S.L
    B.5.2Functional name of contact pointUnidad de Puesta en Marcha
    B.5.3 Address:
    B.5.3.1Street AddressRufino González 14, Esc.1ª-2ºD
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913756930
    B.5.5Fax number+34917542721
    B.5.6E-mailstart-up@sermescro.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.3.1Product nameIMA970A
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNnot yet available
    D.3.9.2Current sponsor codeIMA970
    D.3.9.3Other descriptive nameIMA970
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10.2
    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 Yes
    D.3.11.13.1Other medicinal product typeTherapeutic cancer vaccine
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Endoxan 1 g
    D.2.1.1.2Name of the Marketing Authorisation holderBaxter Oncology GmbH
    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 nameCyclophosphamide
    D.3.2Product code Cy
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCYCLOPHOSPHAMIDE
    D.3.9.1CAS number 50-18-0
    D.3.9.2Current sponsor codeCyclophosphamide
    D.3.9.3Other descriptive nameCy
    D.3.9.4EV Substance CodeSUB06859MIG
    D.3.10 Strength
    D.3.10.1Concentration unit g gram(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 Yes
    D.3.11.13.1Other medicinal product typeImmunemodulator
    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 nameCV8102
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntradermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNot known
    D.3.9.2Current sponsor codeR2025
    D.3.10 Strength
    D.3.10.1Concentration unit g/l gram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeRNA-based immunomodulator
    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
    Very early, early and intermediate stage hepatocellular carcinoma
    Pacientes con carcinoma hepatocelular en estadio muy inicial, inicial o intermedio
    E.1.1.1Medical condition in easily understood language
    Liver Cancer
    Cáncer de higado
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10049010
    E.1.2Term Carcinoma hepatocellular
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the present phase I/II study is to investigate whether treatment with IMA970A plus CV8102 following a single pre-vaccination infusion of cyclophosphamide (CY) is safe and tolerable, and able to induce a T-cell response in very early, early and intermediate stage hepatocellular carcinoma (HCC) patients after any standard treatment and without any evidence of active disease that warrant further treatment.
    El presente estudio en fase I/II tiene por objetivo principal investigar si el tratamiento con IMA970A más CV8102 tras una sola infusión prevacunal de ciclofosfamida (CY) es seguro, tolerable y capaz de fomentar una respuesta de los linfocitos T en pacientes con carcinoma hepatocelular (CHC) en estadio muy inicial, inicial e intermedio que ya han recibido algún tipo tratamiento ordinario y que no muestran indicio alguno de enfermedad activa que exija iniciar otro tratamiento.
    E.2.2Secondary objectives of the trial
    Secondary/exploratory objectives are the investigation of additional immunological parameters, infiltrating T-lymphocytes, immune cells and potential other (bio)markers in tumor tissue, influence of standard therapy on natural immune response to IMA970A, time to progression and overall survival.
    Los objetivos secundarios/exploratorios son la investigación de otros parámetros inmunitarios, Linfocitos T infiltrados, células inmunitarias y otros posibles (bio) marcadores presentes en el tejido tumoral (cuando se disponga de tejido), evaluación del impacto potencial del tratamiento ordinario en la respuesta inmunitaria natural a los péptidos contenidos en la vacuna IMA970A, tiempo hasta la progresión y Supervivencia global.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Aged at least 18 years
    2. HLA type: HLA-A*02 and/or HLA-A*24 positive (Screening 1)
    3. Very early, early and intermediate stage (Barcelona Clinic Liver Cancer (BCLC) stage 0, A, B disease) hepatocellular carcinoma (HCC) diagnosed by biopsy or resected tissue (pathohistological diagnosis), or imaging findings (non-invasive criteria) following any standard treatment (e.g. hepatic resection, RFA/PEI, TACE, and SIRT) and without any evidence of active disease that warrant further treatment
    4. Patients for whom no standard anti-tumor therapy is indicated for the next 3 months (until after visit 7); thereafter any standard anti-tumor therapies applied for the treatment of BCLC stage 0, A and B HCC (e.g. RFA/PEI, TACE, and SIRT) are allowed to be applied in combination with the study treatment. Patients for whom treatment for advanced disease (e.g. sorafenib) is indicated will be withdrawn from study treatment.
    5. Eastern Cooperative Oncology Group (ECOG) performance status 0
    6. Child-Pugh A5-6 and B7-9 disease
    1. Mayores de 18 años
    2. Tipo de HLA:HLA-A*02 o HLA-A*24 positivo (1ª Selección)
    3.Carcinoma hepatocelular (CHC) en estadio muy inicial, inicial o intermedio (estadios 0, A y B en el sistema de clasificación del cáncer hepático BCLC, Barcelona Clinic Liver Cancer) diagnosticado mediante biopsia o tejido extirpado (diagnóstico histopatológico) o imágenes (criterios no invasivos) que ha sido objeto de cualquier tipo de tratamiento ordinario (hepatectomía, RFA/PEI, TACE y SIRT, por ejemplo) y sin indicio alguno de enfermedad activa que exija nuevo tratamiento.
    4.Pacientes sin ninguna indicación de tratamiento antitumoral ordinario para los próximos 3 meses (hasta después de la 7ª visita del estudio); a partir de entonces estará permitido combinar el tratamiento en estudio con cualquier otro tratamiento ordinario contra el cáncer aplicable para el tratamiento del CHC en los estadios BCLC 0, A y B (p. ej. RFA/PEI, TACE y SIRT). A los pacientes que deban recibir tratamiento contra la enfermedad avanzada (p. ej. sorafenib) se les retirará el tratamiento del estudio.
    5. Estado general igual a 0 (PS del ECOG; Eastern Cooperative Oncology Group)
    6. Child-Pugh A (5 ó 6 puntos) o B (7, 8 ó 9 puntos)
    E.4Principal exclusion criteria
    1. Any prior systemic anti-tumor treatment (including drug or treatment regimen, approved or experimental) within 2 weeks before signing of the IC 1 by the patient
    2. Liver transplanted patients; patients who are on the liver transplantation waiting list are allowed to be enrolled
    3. Patients with a history or evidence of systemic autoimmune disease, e.g. rheumatoid arthritis, multiple sclerosis, systemic lupus erythematodes (SLE), scleroderma, Sjögren's syndrome, Wegener's granulomatosis, Guillain-Barre syndrome
    4. Need for concomitant treatment with immunosuppressive drugs or other immune-modifying drugs. The use of inhaled and nasally applied steroids, as well as topical steroids outside the vaccination area are permitted
    5. Any medically diagnosed or suspected condition of immunodeficiency or medical history thereof
    6. Known HIV infection
    7. Acute and active infections requiring oral or intravenous antibiotics, antiviral or antifungal therapy within 30 days prior to signing of the IC 2 by the patient
    8. Patients undergoing renal dialysis or with relevant chronic renal failure
    9. Abnormal laboratory values as specified
    10. Clinically relevant ascites with the only exception of patients that remain free from symptomatic ascites under low-dose diuretics (Spironolactone > 100 mg daily and Furosemide > 40 mg daily).
    11. Evidence of current alcohol or drug abuse
    1.Haber recibido algún tratamiento antitumoral de acción general en las dos semanas previas a la firma del primer consentimiento informado por parte del paciente (regímenes farmacológicos o terapéuticos de cualquier tipo, autorizados o experimentales).
    2. Pacientes que hayan recibido un trasplante de hígado; podrán participar aquellos que figuren en una lista de espera para ese tipo de trasplante
    3. Pacientes con antecedentes o indicios sólidos de enfermedad autoinmunitaria sistémica, como por ejemplo, artritis reumatoide, esclerosis múltiple, lupus eritematoso sistémico (LES), esclerodermia, síndrome de Sjögren, granulomatosis de Wegener o síndrome de Guillain Barré.
    4. Necesidad de tratamiento simultáneo con fármacos inmunodepresores u otro tipo de fármacos que alteren el sistema inmunitario. Se permite el uso de corticoesteroides inhalados o instilados por vía nasal, así como por vía tópica, pero solo fuera de la zona de administración de la vacuna.
    5. Cualquier trastorno de inmunodeficiencia, diagnosticado o presunto, o antecedentes del mismo
    6. Infección por VIH confirmada
    7. Infecciones agudas y activas que exijan la administración por vía endovenosa u oral de antibióticos, antimicóticos o antivirales enlos 30 días previos a la firma del segundo consentimientoinformado por el paciente
    8. Pacientes sometidos a diálisis renal o con insuficiencia renal crónica relevante
    9. Valores analíticos anormales, especificados en el protocolo
    10. Ascitis clínicamente relevante, con la única excepción de aquellos pacientes que permanezcan sin ascitis sintomática al recibir diuréticos en dosis bajas (espironolactona > 100 mg diarios y furosemida > 40 mg diarios).
    11. Indicios de alcoholemia o toxicomanía
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints of the study are safety and tolerability, and immunogenicity (T-cell response in peripheral blood).
    Los criterios principales de valoración del estudio son la seguridad y la tolerabilidad, así como la inmunogenicidad (respuesta de los linfocitos T en la sangre periférica).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety and Tolerability: continuous full safety surveillance between S2 and EOV visit. Limited safety surveillance between S1 and S2 and during the non-interventional follow-up starting after EOV Visit.
    Immunogenicity: PBMCs for immunogenicity assessment will be drawn at visits S1, S2, C, 4, 5, 6, 7, 9, EOV.
    Seguridad y Tolerabilidad: Vigilancia completa continua de la seguridad entre la visita S2 y EOV. Supervisión limitada de la seguridad entre S1 y S2 y durante el seguimiento no intervencional que comienza después de la visita de la EOV.
    Inmunogenicidad: Las evaluaciones de PBMC para la inmunogenicidad se sacarán en las visitas S1, S2, C, 4, 5, 6, 7, 9, EOV.
    E.5.2Secondary end point(s)
    • Additional immunological parameters in blood (e.g. regulatory T-cells, myeloid-derived suppressor cells)
    • Infiltrating T-lymphocytes, immune cells and potential other (bio)markers in tumor tissue (depending on availability of tissue)
    • Assessment of the potential impact of the standard therapy on the natural immune response to peptides contained in IMA970A
    • Time to progression (TTP)
    • Overall survival (OS)
    Otros parámetros inmunitarios analizados a través de la sangre (p. ej. linfocitos T reguladores y células mieloides supresoras)
    • Linfocitos T infiltrados, células inmunitarias y otros posibles
    (bio)marcadores presentes en el tejido tumoral (cuando se disponga de tejido)
    • Evaluación del impacto potencial del tratamiento ordinario en la respuesta inmunitaria natural a los péptidos contenidos en la vacuna IMA970A
    • Tiempo hasta la progresión (TTP)
    • Supervivencia global (SG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Additional immunological parameters in blood: PBMCs for immunogenicity assessment will be drawn at visits S1, S2, C, 4, 5, 6, 7, 9, EOV.
    Infiltrating T-lymphocytes: depending on availability of tumor tissue
    Assessment of potential impact of standard therapy: S1 and S2
    TTP: S1, S2, V7, EOV visit
    OS: continues capture until end-of-trial.
    Otros parámetros inmunitarios analizados a través de la sangre: las evaluaciones PBMC de la inmunogenicidad se sacarán en las visitas S1, S2, C, 4, 5, 6, 7, 9, EOV.
    Linfocitos T infiltrados: dependiendo de la disponibilidad de tejido tumoral.
    Evaluación del impacto potencial del tratamiento ordinario: visitas S1 y S2
    TTP: visitas S1, S2, V7, EOV
    SG: seguimiento hasta el final del ensayo.
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration to Humans for PR1
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state7
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    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)
    Patients who completed the study treatment as defined in the clinical protocol as well as prematurely withdrawn patients will be offered best medical care according to local standard of procedures. In addition, suitable HepaVac-101 patients enrolled in Germany may be invited to participate in an extension clinical study investigating APVACs.
    Tanto a los pacientes que completen el tratamiento del estudio conforme a lo estipulado en el protocolo clínico como a los que se retiren de forma prematura se les ofrecerá el mejor tratamiento médico del sistema nacional de salud de acuerdo la practica clínica habitual. Asimismo, a los pacientes de HepaVac-101 reclutados en Alemania que sean aptos se les podrá invitar a participar en un estudio clínico de extensión que investigará las APVAC.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-04-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-20
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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