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    The EU Clinical Trials Register currently displays   36603   clinical trials with a EudraCT protocol, of which   6045   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2012-005592-13
    Sponsor's Protocol Code Number:FERRICHFII
    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:2013-12-11
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-005592-13
    A.3Full title of the trial
    Mechanisms of Exercise Benefit with Intravenous Iron in Chronic Heart Failure: The Ferric Iron in Heart Failure (FERRIC HF) II Trial
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Mechanisms of Exercise Benefit with Intravenous Iron in Chronic Heart Failure
    A.3.2Name or abbreviated title of the trial where available
    Mechanisms of Exercise Benefit with IV Iron in CHF
    A.4.1Sponsor's protocol code numberFERRICHFII
    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 SponsorKing's 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 supportKing's College London British Heart Foundation Centre
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College London
    B.5.2Functional name of contact pointDr Darlington Okonko
    B.5.3 Address:
    B.5.3.1Street AddressThe James Black Center,125 Coldharbour Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9NU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044207848 5017
    B.5.6E-maildarlington.okonko@kcl.ac.uk
    B.Sponsor: 2
    B.1.1Name of SponsorKing's College Hospital NHS Foundation Trust
    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 supportKing's College London British Heart Foundation Centre
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKing's College NHS Foundation Trust
    B.5.2Functional name of contact pointDr Darlington Okonko
    B.5.3 Address:
    B.5.3.1Street AddressThe James Black Center, 125 Coldharbour Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9NU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0044207848 5017
    B.5.6E-maildarlington.okonko@kcl.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 MONOFER
    D.2.1.1.2Name of the Marketing Authorisation holderPharmacosmos A/S
    D.2.1.2Country which granted the Marketing AuthorisationDenmark
    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 iron (FE 3+)
    D.3.9.1CAS number 9004-66-04
    D.3.9.3Other descriptive nameIRON(III) ISOMALTOSIDE 1000
    D.3.9.4EV Substance CodeSUB74758
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    Chronic Heart Failure
    E.1.1.1Medical condition in easily understood language
    Chronic Heart Failure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10008908
    E.1.2Term Chronic heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of iv iron repletion on skeletal muscle oxidative capacity as quantified by PCr t1/2 and ADP t1/2 following gastrocnemius muscle exercise using 31-P MRS.
    E.2.2Secondary objectives of the trial
    To determine:
    • Change in skeletal muscle ferritin, free iron content, and transferrin receptor levels from baseline to 2 weeks post
    treatment.
    • Change in skeletal muscle fibre type, immunohistochemistry, and aerobic enzyme levels from baseline to 2 weeks
    post treatment.
    • Change in distance walked in 6 minutes from baseline to 2 weeks post treatment.
    • Change in symptom status from baseline to 2 weeks post treatment.
    • Change in haematological and biochemical indices from baseline to 2 weeks post treatment.
    • Number and incidence of adverse events; changes in liver function tests and renal function tests; changes in vital
    parameters.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ≥30 years of age and have signed written informed consent
    • Stable symptomatic CHF; NYHA III/IV and LVEF ≤45%, or if NYHA II then LVEF must be ≤40% as assessed within last 6 months using echocardiographic or magnetic resonance imaging techniques.
    • On optimal conventional therapy for at least 4 weeks prior to recruitment and without dose changes for at least 2 weeks.
    • Screening Hb concentration < 12 g/dl in females and < 13 g/dL in males (anaemic group, 50% of study population) or ≥12 g/dL in females and ≥ 13 g/dL in males (non-anaemic group, 50% of study population).
    • Ferritin <100 g/l or 100-300 g/l with TSAT <20%.
    • Folate and Vitamin B12 levels ≥ lower limit of normal (according to local lab reference range).
    • Resting blood pressure ≤160/100 mmHg.
    • Negative pregnancy test in women of child-bearing age
    E.4Principal exclusion criteria
    • History of acquired iron overload, known haemochromatosis or first relatives with haemochromatosis, and allergic disorders (asthma, eczema, and anaphylactic reactions).
    • Known hypersensitivity to parental iron preparations or any of their excipients.
    • Known active infection, bleeding, malignancy, haemolytic anaemia, and rheumatoid arthritis.
    • History of chronic liver disease with alanine transaminase (ALT) or aspartate transaminase (AST) >3 times the upper limit of the normal range, severe chronic lung disease with FEV1 < 50% predicted, myelodysplastic disorder, and known HIV/AIDS disease.
    • Coagulopathy or anticoagulation with warfarin or warfarin substitutes for a metallic valve or an LV thrombus diagnosed in the last 6 months.
    • Contraindications to magnetic resonance imaging (pacemaker, cardiac resynchronization therapy device, internal cardiac defibrillator, metal prostheses, excessive claustrophobia)
    • Recipient of immunosuppressive therapy or renal dialysis.
    • Anticipated need for erythropoietin or a blood transfusion during the study.
    • Unstable angina as judged by the investigator, severe uncorrected non-functional valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, uncontrolled fast atrial fibrillation or flutter (>110 bpm), uncontrolled symptomatic brady- or tachyarrhythmias.
    • Musculoskeletal limitation that, in the investigators judgement, would impair exercise testing.
    • Pregnant or breast-feeding
    • Inability to comprehend study protocol
    • Parallel participation in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    Change in skeletal muscle oxidative capacity as assessed by PCr t1/2 from baseline to 2 weeks post last treatment.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Endpoint will be evaluated at baseline and study end (2 weeks post last treatment)
    E.5.2Secondary end point(s)
    • Change in skeletal muscle oxidative capacity as assessed by ADP t1/2 from baseline to 2 weeks post last treatment.
    • Change in skeletal muscle oxidative capacity as reflected by mitochondrial oxygen consumption per mg of muscle tissue measured using a respirometer from baseline to 2 weeks post last treatment.
    • Change in skeletal muscle ferritin, free iron content, and transferrin receptor levels from baseline to 2 weeks post last treatment.
    • Change in skeletal muscle fibre type, immunohistochemistry, and aerobic enzyme mRNA and protein levels from baseline to 2 weeks post last treatment.
    • Change in distance walked in 6 minutes from baseline to 2 weeks post last treatment.
    • Change in cardiopulmonary exercise (CPEX) parameters (peak oxygen consumption and ventilation to carbon dioxide production ratio) from baseline to 2 weeks post last treatment.
    • Change in symptom status (NYHA class, Kansas City Cardiomyopathy questionnaire [KCCQ], visual analogue fatigue scale [VAFS]) from baseline to 2 weeks post treatment.
    • Change in haematological and biochemical indices (Hb, Hct, reticulocyte count, iron status, N-terminal brain natiuretic peptide [NT-BNP], cytokines and oxidative stress) from baseline to 2 weeks post treatment.
    • Change in cardiac function and tissue doppler indices on echocardiography.
    • Change in erythroid precursor and progenitor numbers on flow cytometry and cell culture.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Endpoint will be evaluated at baseline and study end (2 weeks after last treatment)
    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 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 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
    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 months8
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    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 received saline during the trial period will be offered a course of iv iron iron at the end if they remain iron
    deficient. Patients will have their iron status regularly evaluated after the trial and will be supplemented as appropriate.
    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 Decision2014-02-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-20
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