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    Summary
    EudraCT Number:2012-005480-28
    Sponsor's Protocol Code Number:IJG-FER-2012
    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:2013-04-09
    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 number2012-005480-28
    A.3Full title of the trial
    Effectiveness of adaptation of the dose of iron supplementation in pregnancy on maternal-child health. Randomized clinical trial (ECLIPSES)
    Efectividad de la adaptación de la dosis de suplementación con hierro en el embarazo sobre la salud materno-filial. Ensayo Clínico Aleatorizado (ECLIPSES)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effectiveness of adaptation of the dose of iron supplementation in pregnancy on maternal-child health. Randomized clinical trial (ECLIPSES)
    Efectividad de la adaptación de la dosis de suplementación con hierro en el embarazo sobre la salud materno-filial. Ensayo Clínico Aleatorizado (ECLIPSES)
    A.3.2Name or abbreviated title of the trial where available
    ECLIPSES
    ECLIPSES
    A.4.1Sponsor's protocol code numberIJG-FER-2012
    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 SponsorInstitut d?Investigació en Atenció Primaria IDIAP Jordi Gol
    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 supportInstituto Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut d?Investigació en Atenció Primaria IDIAP Jordi Gol
    B.5.2Functional name of contact pointPau Moreno
    B.5.3 Address:
    B.5.3.1Street AddressGran Via de les Corts Catalanes 587 Atic
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08007
    B.5.3.4CountrySpain
    B.5.4Telephone number34934824572
    B.5.5Fax number34934824174
    B.5.6E-mailpmoreno@idiapjgol.org
    D. IMP Identification
    D.IMP: 1
    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 PROFER 40 mg Granulado
    D.2.1.1.2Name of the Marketing Authorisation holderTEDEC-MEIJI FARMA, 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.3.1Product namePROFER 40 mg
    D.3.2Product code 830182
    D.3.4Pharmaceutical form Powder for 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 INNferrimanitol ovalbumin
    D.3.9.3Other descriptive nameFERRIMANITOL OVALBUMIN
    D.3.9.4EV Substance CodeSUB31658
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 nameFERROPROTINA
    D.3.2Product code 980243
    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 INNferrimanitol ovalbumin
    D.3.9.3Other descriptive nameFERRIMANITOL OVALBUMIN
    D.3.9.4EV Substance CodeSUB31658
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 Yes
    D.2.1.1.1Trade name PROFER 80 mg Granulado
    D.2.1.1.2Name of the Marketing Authorisation holderTEDEC-MEIJI FARMA, 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.3.1Product nameProfer 80mg
    D.3.2Product code 661499
    D.3.4Pharmaceutical form Powder for 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 INNferrimanitol ovalbumin
    D.3.9.3Other descriptive nameFERRIMANITOL OVALBUMIN
    D.3.9.4EV Substance CodeSUB31658
    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.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
    Pregnant women, less than 12 week of gestations,without anemia (Hb <110 d / dL) in the pre-analytical at 12 weeks
    Mujeres embarazadas de menos de 12 semanas de gestacion sin anemia
    E.1.1.1Medical condition in easily understood language
    Pregnant women less than 12 weeks of gestation, with normal iron levels.
    Mujeres embarazadas de menos de 12 semanas de gestacion, con estado del hierro normal
    E.1.1.2Therapeutic area Diseases [C] - Parasitic Diseases [C03]
    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
    -Decreasing the percentage of iron deficiency anemia at the end of gestation in women with baseline hemoglobin of 110 to 130 g / L, which is supplemented with 80 mg / day of iron regarding which are supplemented with 40 mg / day.
    ? Reduce the risk of hemoconcentration percentage at the end of pregnancy in women with baseline hemoglobin greater than 130 g / L, which are supplemented with 20 mg / day of iron compared to those who were supplemented with 40 mg / day.
    ? Disminuir el porcentaje de anemia ferropénica al final de gestación en las mujeres con hemoglobina inicial de 110 a 130 g/L, que son suplementadas con 80 mg/día de hierro respecto a las que son suplementadas con 40 mg/día.
    ? Disminuir el porcentaje de riesgo de hemoconcentración al final de gestación en las mujeres con hemoglobina inicial mayor a 130 g/L, que son suplementadas con 20 mg/día de hierro respecto a las que son suplementadas con 40 mg/día.
    E.2.2Secondary objectives of the trial
    ? Analyze the relationship that initial serum ferritin values ??and the presence of mutations in the HFE gene have on hemoglobin values??, the percentage of anemia and hemoconcentration risk at the end of gestation.
    ? Assess fetal anthropometric development, assessed by ultrasound, and the newborn in the groups supplemented with 80 or 20 mg / day of iron compared to the usual dose of 40 mg / day.
    ? Assess anthropometric development, cognitive and behavioral baby at 40 days of delivery, in the groups supplemented with 80 or 20 mg / day of iron compared to the usual dose of 40 mg / day.
    ? Assess the safety and adverse effects of treatment in the different branches of the test.
    ? Analizar la relación que los valores de ferritina sérica iniciales y la presencia de mutaciones en el gen HFE tienen sobre los valores de hemoglobina, el porcentaje de anemia y de riesgo de hemoconcentración al final de la gestación.
    ? Valorar el desarrollo antropométrico del feto, valorado mediante ecografía, y del recién nacido en los grupos suplementados con 80 o 20 mg/día de hierro respecto a la dosis habitual de 40 mg/día.
    ? Valorar el desarrollo antropométrico, cognitivo y conductual del bebé a los 40 días del parto, en los grupos suplementados con 80 o 20 mg/día de hierro respecto a la dosis habitual de 40 mg/día.
    ? Valorar la seguridad y los efectos adversos del tratamiento en las diferentes ramas del ensayo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? adult woman
    ? ICS belonging to
    ? pregnant less than 12 weeks gestation
    ? to understand the Castilian or Catalan
    ? sign the informed consent
    ? without anemia (Hb <110 d / dL) in the pre-analytical at 12 weeks
    ? Mujer mayor de edad
    ? perteneciente al ICS
    ? embarazada con menos de 12 semanas de gestación
    ? que entienda el castellano o el catalán
    ? que firme el consentimiento informado
    ? sin anemia (Hb < 110 d/dL) en la analítica previa a las 12 semanas
    E.4Principal exclusion criteria
    ? Multiple or risk pregnancy.
    ? Taking iron supplements containing 10mg iron than in the previous three months
    ? Pregnant women with hypersensitivity to the active substance, hypersensitivity to egg proteins or intolerant to fructose or galactose.
    ? chronic or severe pre-existing disease that affects the nutritional development, such as cancer, diabetes mellitus and other metabolic diseases, malabsorptive diseases such as Crohn's disease, ulcerative colitis, gastro-duodenal ulcers, and liver diseases such as chronic hepatitis, liver cirrhosis and chronic pancreatitis.
    ? Immunosuppression: chronic HIV infection, transplant, neutropenic, or patients receiving immunosuppressive therapy.
    ? Embarazo de riesgo o múltiple.
    ? Toma de suplementos de hierro con un contenido en hierro superior a 10mg en los tres meses anteriores
    ? Embarazadas con hipersensibilidad al principio activo, hipersensibilidad a las proteínas del huevo o intolerantes a la fructosa o galactosa.
    ? Patología previa crónica o grave que afecte al desarrollo nutricional, como por ejemplo cáncer, diabetes mellitus y otras enfermedades metabólicas; enfermedades malabsortivas como por ejemplo enfermedad de crohn, colitis úlcerosa; úlcera gastro-duodenal, y enfermedades hepáticas como hepatitis crónica,cirrosis hepática y pancreatitis crónica.
    ? Inmunosupresión: infección crónica por VIH, trasplantados, neutropénicos, o bien, pacientes que reciben tratamiento inmunosupresor.
    E.5 End points
    E.5.1Primary end point(s)
    Haemoglobin Levels
    Niveles de hemoglobina
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 36 of gestation
    a la semana 36 de la gestacion
    E.5.2Secondary end point(s)
    Assess the improved iron status and Hb by FS and assess the effect of the presence of polymorphisms C282Y, H63D HFE on iron status
    Assess anthropometric development of the fetus in the first ultrasound (nuchal translucideza through) in the second and third ultrasound (using the estimated weight of the fetus) and newborn (weight and height at birth)
    Assess development improved anthropometric (weight, length and head circumference) and neurorconductual development (using the Bayley Scales, Carey test and link test) infant
    Assess for adverse events in both arms throughout the whole trial
    Valorar la mejora del estado del hierro mediante la Hb y la FS y valorar el efecto que tiene la presencia de los polimorfismos C282Y, H63D del gen HFE sobre el estado del hierro
    Valorar el desarrollo antropométrico del feto, en la primera ecografía (mediante la translucideza nucal) en la segunda y tercera ecografía (mediante el peso estimado del feto) y del recién nacido (peso y talla al nacer)
    Valorar la mejora del desarrollo antropométrico (peso, talla y perímetro cefálico) y del desarrollo neurorconductual (mediante las escalas de Bayley, test de Carey, y el test de vínculo) del lactante
    Valorar la presencia de acontecimientos adversos en las dos ramas a lo largo de todo el ensayo
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the trial
    Al final del estudio
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    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 trial4
    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
    LVLS
    última visita ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    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: 878
    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 No
    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 state878
    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
    none
    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 Decision2013-05-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-07
    P. End of Trial
    P.End of Trial StatusCompleted
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