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    Summary
    EudraCT Number:2016-000609-36
    Sponsor's Protocol Code Number:FIFERM03
    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:2019-04-11
    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 number2016-000609-36
    A.3Full title of the trial
    Study of the use of Liposomal Iron in the treatment of iron deficiency anemia in pregnancy and puerperium
    Estudio de empleo de Hierro Liposomado en el tratamiento de la anemia ferropénica en el embarazo y puerperio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the use of Liposomal Iron in the treatment of iron deficiency anemia (a condition in which blood lacks adequate number of red blood cells due to insufficient iron. Without enough iron, your body can't produce enough of a substance in red blood cells that enables them to carry oxygen, hemoglobin) in pregnancy and puerperium (The period of about six weeks after childbirth during which the mother's reproductive organs return to their original non-pregnant condition)
    Estudio de empleo de Hierro Liposomado en el tratamiento de la anemia ferropénica (disminución en el número de glóbulos rojos en la sangre por falta de hierro , el cual es necesario para la formación de la hemoglobina y esta para la de los glóbulos rojos) en el embarazo y puerperio (Período de tiempo que dura la recuperación completa del aparato reproductor después del parto, que suele durar entre cinco y seis semanas)
    A.4.1Sponsor's protocol code numberFIFERM03
    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 SponsorHospital Vall d´Hebrón
    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 supportHospital Vall d´Hebrón
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationManel Casellas Caro
    B.5.2Functional name of contact pointManel Casellas Caro
    B.5.3 Address:
    B.5.3.1Street AddressPasseig Vall d´Hebron 119-129
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number0034667566 342
    B.5.6E-mailmacasell17302@gmail.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 Yes
    D.2.1.1.1Trade name Fisiogen ferro forte
    D.2.1.1.2Name of the Marketing Authorisation holderBiofarma S.p.A. Udine
    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
    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 INNFerric Pyrophosphate
    D.3.9.1CAS number 10058-44-3
    D.3.9.2Current sponsor code164328
    D.3.9.3Other descriptive nameFERRIC PYROPHOSPHATE
    D.3.9.4EV Substance CodeSUB13847MIG
    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: 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 Tardyferon
    D.2.1.1.2Name of the Marketing Authorisation holderPIERRE FABRE IBÉRICA, 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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDried Ferrous Sulphate BP
    D.3.9.1CAS number 70192-61-7
    D.3.9.2Current sponsor code52994
    D.3.9.3Other descriptive nameDRIED FERROUS SULPHATE BP
    D.3.9.4EV Substance CodeSUB178765
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Iron deficiency anemia
    anemia ferropénica
    E.1.1.1Medical condition in easily understood language
    Iron deficiency anemia, a condition in which blood lacks adequate number of red blood cells due to insufficient iron
    anemia ferropénica que es debida a una disminución en el número de glóbulos rojos en la sangre por falta de hierro
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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
    Evaluate the efficacy of a liposome iron food supplement in the treatment of iron deficiency anemia in pregnant women, compared with the standard: ferrous sulfate
    Evaluar la eficacia de un complemento alimenticio de hierro liposomado en el tratamiento de la anemia ferropénica en la gestante, comparado con el estándar: sulfato ferroso
    E.2.2Secondary objectives of the trial
    Evaluate the secondary effects of the treatment with liposome iron and ferrous sulphate and the rate of abandonment due to intolerance.

    Evaluate the kinetics of iron in the newborn via a sample obtained from blood cord and for the study of ferritin, transferrin and transferrin saturation index
    Evaluar los efectos secundarios del tratamiento con hierro liposomado y sulfato ferroso y la tasa de abandono del mismo por intolerancia.

    Evaluar la cinética del hierro en el recién nacido mediante muestra obtenida de sangre de cordón para estudio de ferritina, transferrina e indice de saturación de la transferrina
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Age over 18 years.
    -Pregnancy with a single fetus.
    -Figures of hemoglobin, ferritin, transferrin and transferrin saturation index described in the selection of subjects. -Have completed a basic study on the etiology of anemia.
    -Known gestational age.
    -Acceptance of participating in the study and signing of informed consent.
    -Intake of folic acid, vitamin B12 or iodine with the recommendation / supplementation standards existing in pregnancy
    -Edad superior a 18 años.
    -Embarazo con feto único.
    -Cifras de hemoglobina, ferritina, transferrina e índice de saturación de la transferrina descritas en la selección de sujetos.
    -Haber cumplimentado un estudio básico sobre la etiología de la anemia.
    -Edad gestacional conocida.
    -Aceptación de participar en el estudio y firma del consentimiento informado.
    -Ingesta de ácido fólico, vitamina B12 o yodo con los estándares de recomendación/suplementación existentes en el embarazo.
    E.4Principal exclusion criteria
    Presence of intercurrent haematological diseases (haemosiderosis, hemochromatosis, sideroblastic or sideracestic anemias, thalassemia) or of another nature.
    Previous blood transfusion in the month prior to inclusion in the study.
    Intake of polyvitamins containing iron.
    Patient who is suspected of low predictable compliance.
    Patients with poor adherence to the treatment objectified as described in the therapeutic compliance section.
    Obstetric or medical-surgical situations involving blood loss (eg, placenta previa, bleeding gastric ulcer, hemorrhoids).
    Kidney chronic disease
    Diseases known to cause specific difficulty for the absorption of iron orally (eg some types of bariatric surgery).
    Interruption of pregnancy for whatever reason two months after initiating the protocol.
    Severe iron deficiency anemia or anemia with hemoglobin in the inclusion range but with poor clinical tolerance, which makes them parenteral iron tributaries.
    Iron allergy
    Contraindication to folic acid or vitamin B12
    Presencia de enfermedades hematológicas intercurrentes (hemosiderosis, hemocromatosis, anemias sideroblásticas o sideraocrésticas, talasemia) o de otra naturaleza.
    Transfusión previa de sangre en el mes anterior a la inclusión en el estudio.
    Ingesta de polivitamínicos que contengan hierro.
    Paciente de quien se sospeche un bajo cumplimiento predecible.
    Pacientes con mala adherencia al tratamiento objetivado según lo descrito en el apartado de cumplimiento terapéutico.
    Situaciones obstétricas o médico-quirúrgicas que comporten pérdida de sangre (p.ej. placenta previa, ulcus gástrico sangrante, hemorroides).
    Insuficiencia renal crónica
    Enfermedades que se conoce comportan dificultad específica para la absorción del hierro por vía oral (p.ej. algunos tipos de cirugía bariátrica).
    Interrupción del embarazo por el motivo que sea antes de dos meses de iniciar el protocolo.
    Anemias ferropénicas severas o anemias con hemoglobina en rango de inclusión pero que presentan mala tolerancia clínica, lo que las haga tributarias de hierro parenteral.
    Alergia al hierro.
    Contraindicación al ácido fólico o vitamina B12.
    E.5 End points
    E.5.1Primary end point(s)
    Evolution of hemoglobin levels throughout the treatment.
    A record of the recovery of Hb levels at the end of the study will be made, considering as a positive response:
    -Patients who do not suffer from anemia at the end of pregnancy.
    -Increase of at least 1g / dl at 12 weeks compared to baseline
    Evolución de los niveles de hemoglobina a lo largo del tratamiento.
    Se realizará un registro de la recuperación de los niveles de Hb al final del estudio, considerándose como respuesta positiva:
    -Pacientes que no padecen anemia a término del embarazo.
    -Incremento de al menos 1g/dl a las 12 semanas respecto al valor basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    First Quarter
    Selection visit: Week 12
    2nd visit: Week 16-17
    3rd visit: Week 24-26
    4th visit: Week 30
    5th visit: Week 34-36
    6th visit: Pre labour
    Post Labour visit: Week 2-3 puerperium

    Second quarter
    Selection visit: Week 24
    Second visit: Week 29-30
    Third visit: Week 34-36
    Post Labour visit: Week 2-3 puerperium
    Primer trimestre
    Visita de selección: Semana 12
    2ª visita: Semana 16-17
    3ª visita: Semana 24-26
    4ª visita: Semana 30
    5ª visita: Semana 34-36
    6ª visita: Preparto
    Visita postparto: Semana 2-3 puerperio

    Segundo trimestre
    Visita de Selección: Semana 24
    Segunda visita:Semana 29-30
    Tercera visita: Semana 34-36
    Visita postparto: Semana 2-3 puerperio
    E.5.2Secondary end point(s)
    - Analytical parameters: ferritin, transferrin, transferrin saturation index.
    Laboratory evaluations will collect complete blood count and iron kinetics data.

    -Side effects in each treatment group.
    The tolerability that patients present to treatment will be evaluated; for this, a questionnaire will be carried out in which the general welfare of the patient as well as different gastrointestinal symptomatology will be collected
    The appearance of gastrointestinal symptoms such as:
    Sickness
    Vomiting
    Epigastralgia
    Change in stool color
    Constipation
    -Parámetros analíticos: ferritina, transferrina, transferrin saturation index.
    Las evaluaciones de laboratorio recogerán hemograma completo y datos de cinética de hierro.

    -Efectos secundarios en cada grupo de tratamiento.
    Se evaluará la tolerabilidad que presentan los pacientes al tratamiento; para ello, se efectuará un cuestionario en el que se recogerá el bienestar general del paciente así como diferente sintomatología gastrointestinal
    La aparición de síntomas gastrointestinales como:
    Náuseas
    Vómitos
    Epigastralgia
    Cambio de coloración en las heces
    Estreñimiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Analytical parameters
    First Quarter
    Selection visit: Week 12
    2nd visit: Week 16-17
    3rd visit: Week 24-26
    4th visit: Week 30
    5th visit: Week 34-36
    6th visit: Pre labour
    Post Labour visit: Week 2-3 puerperium

    Second quarter
    Selection visit: Week 24
    Second visit: Week 29-30
    Third visit: Week 34-36
    Post Labour visit: Week 2-3 puerperium

    -Side effects in each treatment group
    First Quarter
    2nd visit: Week 16-17
    3rd visit: Week 24-26
    4th visit: Week 30
    5th visit: Week 34-36
    Post Labour visit: Week 2-3 puerperium

    Second quarter
    Second visit: Week 29-30
    Third visit: Week 34-36
    Post Labour visit: Week 2-3 puerperium
    - Parámetros analíticos.
    Primer trimestre
    Visita de selección: semana 12
    2ª visita: semana 16-17
    3ª visita: semana 24-26
    4ª visita: semana 30
    5ª visita: semana 34-36
    6ª visita: Preparto
    Visita postparto: semana 2-3 puerperio

    Segundo trimestre
    Visita de selección: semana 24
    Segunda visita: semana 29-30
    Tercera visita: semana 34-36
    Visita postparto: semana 2-3 puerperio

    -Efectos secundarios en cada grupo de tratamiento.
    Primer trimestre
    2ª visita: semana 16-17
    3ª visita: semana 24-26
    4ª visita: semana 30
    5ª visita: semana 34-36
    Visita postparto: semana 2-3 puerperio

    Segundo trimestre
    Segunda visita: semana 29-30
    Tercera visita: semana 34-36
    Visita postparto: semana 2-3 puerperio
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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
    12 months of enrolment period + 28 weeks of patient full participation
    12 meses de período inclusión + 28 semanas de participación del paciente
    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 days15
    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: 120
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 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 state120
    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)
    No
    No
    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 Decision2019-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-02
    P. End of Trial
    P.End of Trial StatusOngoing
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