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    The EU Clinical Trials Register currently displays   37221   clinical trials with a EudraCT protocol, of which   6123   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-002786-35
    Sponsor's Protocol Code Number:12/0246
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-07
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-002786-35
    A.3Full title of the trial
    A randomised double-blind controlled phase III study to compare the efficacy and safety of intravenous ferric carboxymaltose with placebo in patients with anaemia undergoing major open abdominal surgery
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PREVENTT (Preoperative intravenous iron to treat anaemia in major surgery)
    A.3.2Name or abbreviated title of the trial where available
    Preoperative intravenous iron to treat anaemia in major surgery
    A.4.1Sponsor's protocol code number12/0246
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN67322816
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01692418
    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 SponsorUniversity College London
    B.1.3.4CountryUnited Kingdom
    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 supportNIHR Health Technology Assessment programme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLondon School of Hygiene & Tropical Medicine
    B.5.2Functional name of contact pointLaura Van Dyck
    B.5.3 Address:
    B.5.3.1Street AddressDept of Medical Statistics, Keppel Street
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeWC1E 7HT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number020 7927 2075
    B.5.5Fax number020 7927 2189
    B.5.6E-maillaura.vandyck@lshtm.ac.uk
    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 Ferinject
    D.2.1.1.2Name of the Marketing Authorisation holderVifor France SA
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameFerric Carboxymaltose (Ferinject)
    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 0009007-72-1
    D.3.9.4EV Substance CodeAS2
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Anaemia
    E.1.1.1Medical condition in easily understood language
    Anaemia
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10022972
    E.1.2Term Iron deficiency anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine if a single dose of intravenous iron given to patients with anaemia prior to major open abdominal surgery, reduces the need for peri-operative blood transfusion (the peri-operative period is defined as from randomisation to the trial until 30 days following operation)
    E.2.2Secondary objectives of the trial
    To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on change in haemoglobin levels.

    To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on post-operative morbidity, length of hospital stay and mortality.

    To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on health related quality of life.

    To evaluate resource use and costs associated with the treatment with intravenous ferric carboxymaltose (Ferinject®) compared with placebo.

    To evaluate the tolerability and safety of Ferinject® compared with placebo from randomisation till study termination.

    To evaluate the effect of intravenous ferric carboxymaltose (Ferinject®) compared with placebo on:
    o Complications of the intervention itself.
    o Complications from blood transfusion or blood products.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. At least 18 years of age and signed written informed consent.
    2. Patients undergoing elective major open abdominal surgery.
    a. The Indication for operation may be for benign or malignant disease.
    b. Major Surgery is defined as an operation of anticipated duration more than one hour.
    3. Screening haemoglobin (Hb) greater than or equal to 90 g/L (9.0 g/dL) but below or equal to 120 g/L (12.0 g/dL) in women or 130g/L (13.0g.dL) in men within four weeks of randomisation.
    4. Randomisation and administration of study infusion a minimum of 10 days and maximum 42 days before planned operation.
    5. Negative pregnancy test for women of childbearing potential (within last 7 days), and agree to use effective form of contraception until 6 weeks post treatment.
    6. Laboratory data used for determination of eligibility at the baseline visit must not be older than four weeks.
    E.4Principal exclusion criteria
    1. Patients undergoing laparoscopic surgery.
    2. Body weight under 50kg.
    3. Known history of acquired iron overload, or family history of haemochromatosis or thalassemia or TSAT >50%.
    4. Known reason for anaemia (e.g. untreated B12 or folate deficiency or haemoglobinopathy).
    5. Known hypersensitivity to ferric carboxymaltose (Ferinject®) or its excipients.
    6. Temperature > 37.5C or patient on non-prophylactic antibiotics
    7. Known chronic liver disease
    8. If clinically indicated for the patient to have LFT’s as part of preassessment for surgery and this screening alanine transaminase (ALT) or aspartate transaminase (AST) is above three times the upper limit of the normal range.
    9. Received erythropoietin or i.v. iron therapy in the previous 12 weeks.
    10. Immunosuppressive therapy (for organ transplantation) or renal dialysis (current or planned within the next 12 months).
    11. Patients with severe asthma or severe allergy (requiring hospitalisation within the last 12 months).
    12. Unfit for elective surgery.
    13. Pregnancy or lactation.
    14. Inability to fully comprehend and/or perform study procedures in the investigator’s opinion.
    15. Patient involvement in another IMP trial within the previous 4 weeks, prior to randomisation. Involvement in another IMP trial, following randomisation, that may impact on the results of the PREVENTT trial.


    E.5 End points
    E.5.1Primary end point(s)
    The co-primary outcomes are:
    • Risk of blood transfusion or death from randomisation until 30-days following the index operation.
    • Blood transfusion rate (including repeat transfusions) from randomisation until 30-days following the index operation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    30-days post operation
    E.5.2Secondary end point(s)
    Change in haemoglobin levels; total number of units of blood transfused; post operative morbidity; change in health related quality of life (HRQOL); health economic outcome; safety & related efficacy outcomes.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Change in haemoglobin levels – at operation and 8 weeks and 6 months post operation;
    Total number of units of blood transfused – at 30 days post operation;
    Post operative morbidity – at 3 days, 5 days, 7 days and 14 days post operation;
    Change in HRQOL from baseline to – 10 days post transfusion, 8 weeks and 6 months post operation.
    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) 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 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) No
    E.8.2.2Placebo Yes
    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 concerned35
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months11
    E.8.9.1In the Member State concerned days31
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months11
    E.8.9.2In all countries concerned by the trial days31
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    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 state500
    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)
    Standard care will resume.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-10-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-05-10
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