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    Summary
    EudraCT Number:2016-002660-13
    Sponsor's Protocol Code Number:FEHD
    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:2016-09-30
    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 number2016-002660-13
    A.3Full title of the trial
    Treatment of Ferropenic Anaemia due to acute gastrointestinal bleeding: oral vs intravenous iron therapy
    TRATAMIENTO DE LA ANEMIA FERROPÉNICA POSTHEMORRAGIA DIGESTIVA AGUDA: FERROTERAPIA ORAL VS IV
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with intravenous iron versus oral iron in anemia by acute gastrointestinal bleeding.
    Tratamiento con hierro intravenoso frente a hierro oral en la anemia por hemorragia digestiva aguda.
    A.4.1Sponsor's protocol code numberFEHD
    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 SponsorConsorcio Hospital General Universitario de Valencia
    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 supportConsorcio Hospital General Universitario de Valencia
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationConsorcio Hospital General Universitario de Valencia
    B.5.2Functional name of contact pointSecretaría de Patología Digestiva
    B.5.3 Address:
    B.5.3.1Street AddressAvda Tres Cruces, 2
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46014
    B.5.3.4CountrySpain
    B.5.4Telephone number0034963131800
    B.5.5Fax number0034963131800
    B.5.6E-mailluis.ferrer.barcelo@gmail.com
    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 Ferinject 50 mg/ml Solución inyectable y para perfusión
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    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 Solution for injection/infusion
    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 INNFERRIC CARBOXYMALTOSE
    D.3.9.1CAS number 9007-72-1
    D.3.9.4EV Substance CodeSUB66620
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Ferogradumet 105 mg comprimidos de liberación prolongada
    D.2.1.1.2Name of the Marketing Authorisation holderTEOFARMA SRL
    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 Prolonged-release 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 INNIRON SULFATE
    D.3.9.1CAS number 7720-78-7
    D.3.9.3Other descriptive nameFERROUS SULFATE
    D.3.9.4EV Substance CodeSUB13877MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number525
    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
    FERROPENIC ANAEMIA DUE TO ACUTE GASTROINTESTINAL BLEEDING
    ANEMIA FERROPÉNICA SECUNDARIA A HEMORRAGIA DIGESTIVA AGUDA
    E.1.1.1Medical condition in easily understood language
    FERROPENIC ANAEMIA AFTER A GASTROINTESTINAL BLEEDING
    ANEMIA FERROPÉNICA TRAS HEMORRAGIA DIGESTIVA AGUDA
    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
    Study the evolution of the ferropenic anaemia due to an acute gatrointestinal bleeding not secundary to portal hypertension comparing two different ways of iron supplement administration (Oral vs Intravenous).
    Estudiar la evolución de la anemia ferropénica posthemorragia digestiva aguda no secundaria a hipertensión portal, comparando dos pautas de tratamiento con Fe: oral e infusión endovenosa.
    E.2.2Secondary objectives of the trial
    Study if the life quality of patiens improves depending on which treatement they have been administrated.
    Estudiar si la calidad de vida de los pacientes mejora en función del tratamiento administrado.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18 year old patients admited in a hospital due to an acute gastrointestinal bleeding, which present a Hb<10 g/dl, once the bleeding has stopped and the patient is stable.
    - Consent form signed.
    • Pacientes mayores de 18 años ingresados en un hospital de 3er nivel por hemorragia digestiva aguda, tanto alta como baja y que presentan al alta hospitalaria una Hb < 10 g/dl, estando cedida la hemorragia digestiva y el paciente en estabilidad clínica.
    • Firma de consentimiento informado.
    E.4Principal exclusion criteria
    -Associated disease which can influence the evolution of the anaemia (renal chronic failure, liver disease, inflammatory bowel disease, neoplasia, non controlled thyroid disease, malabsorption, folate deficency and/or cianocobalamine deficiency, epo treatement, HIV and hematic disorder).
    - Gastrointestinal bleeding during the following (the administration of iron supplement).
    - Need of blood transfusion during the following (during the administration of iron supplement)
    - Anaemia of a different origin to ferropenia.
    - Previous chronic anaemia from any origin.
    - Contraindication to any drug used in the trial.
    • Patología asociada que puede influir en la evolución de la anemia (insuficiencia renal crónica, hepatopatía, enfermedad inflamatoria crónica, neoplasias, alteraciones tiroideas no compensadas, malabsorción, déficit de ácido fólico y/o vitamina B12, tratamiento con eritropoyetina, VIH, trastornos hematológicos).
    • Recidiva hemorrágica entre el día 0 y el día 42.
    • Requerimiento transfusional en el periodo comprendido entre el día 0 y el día 42.
    • Anemias de origen mixto (no ferropénica pura).
    • Anemias crónicas previas de cualquier origen.
    • Contraindicación a la toma de alguno de los fármacos empleados en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    - Evolution of hemoglobin levels.
    - Evolution of iron levels (TSI, Fe, Ferritin)
    - Quality of life (EuroQoL-5, SF36)
    - Adherence to the treatment
    - Adverse effects
    • Evolución de las cifras de Hb (días 0, 7, 21, 42)
    • Evolución de las cifras de parámetros del Fe (días 0, 7, 21, 42)
    • Calidad de vida (EuroQoL-5, SF 36)
    • Adherencia al tratamiento
    • Efectos adversos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 0 (at discharge), Days: 7-21-42
    Día 0 (al alta hospitalaría), días: 7- 21 - 42
    E.5.2Secondary end point(s)
    - Gastrointestinal bleeding ethiology
    - Presence of anticoagulation/antiagregation/proton bomb inhibitors
    - Number of transfunded patients
    - Number of hemoderivated units transfused
    • Diagnóstico de origen de la hemorragia digestiva
    • Presencia de anticoagulación/antiagregación/IBP
    • Número de pacientes transfundidos
    • Unioades de concentrado de hematíes transfundidas
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 0 (discharged)
    Día 0 (al alta hospitalaria)
    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 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS (day 42)
    Última visita del ensayo (día 42)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-09-30. Yes
    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 state100
    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)
    Clinical practice following
    Seguimiento clínico según práctica clínica habitual.
    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 Decision2016-11-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-11-02
    P. End of Trial
    P.End of Trial StatusOngoing
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