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    Summary
    EudraCT Number:2013-004704-19
    Sponsor's Protocol Code Number:3200
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2015-11-25
    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 number2013-004704-19
    A.3Full title of the trial
    Globifer Forte® Oral Haem and Non-haem Iron Supplementation in Heart Failure: A Randomised, DoubleBlind, Placebo Controlled, Double Dummy,
    Part Mechanistic.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Globifer Forte in Heart Failure (GLOBIFER HF)
    A.3.2Name or abbreviated title of the trial where available
    Globifer Forte in Heart Failure (GLOBIFER HF)
    A.4.1Sponsor's protocol code number3200
    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 via British Heart Foundation grant
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportGlobifer International
    B.4.2CountryBelgium
    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 point Dr Darlington Okonko
    B.5.3 Address:
    B.5.3.1Street AddressBHF Centre of Research Excellence KCL, 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 number+44207848 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 via British Heart Foundation grant
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportGlobifer international
    B.4.2CountryBelgium
    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 AddressBHF Centre of Research Excellence, KCL, James Black Centre, 125 Coldharbour Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9NU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44207848 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 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 nameGlobifer Forte
    D.3.4Pharmaceutical form 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 INNGlobifer Forte
    D.3.9.3Other descriptive nameHAEMOGLOBIN
    D.3.9.4EV Substance CodeSUB12512MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number18
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    D.3.11.13.1Other medicinal product typeFood Supplement containing bovine haemoglobin
    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 FERROUS SULPHATE TABLETS BP 200mg
    D.2.1.1.2Name of the Marketing Authorisation holderAccord UK Limited
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Exercise tolerance of Chronic heart failure patients.
    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 20.0
    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 3 months of Globifer Forte® treatment on exercise capacity, as quantified by the 6 minute walk distance (6MWD), in CHF patients with functional or absolute iron deficiency.
    E.2.2Secondary objectives of the trial
    •To evaluate the effect of sera from CHF patients on DMT-1, FPN, HCP-1, HRG-1, and FLVCR2 protein expression on Caco-2 duodenal cell lines.
    •To compare the change in serum iron levels 3 hours after oral FeSO4, Globifer Forte® or placebo tablets (oral absorption test).
    •To evaluate the effect of 3 months of Globifer Forte® treatment on iron status, symptoms and quality of life in CHF patients with functional or absolute iron deficiency
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • ≥30 years of age
    •Signed written informed consent
    •Stable symptomatic CHF; NYHA II,III or ambulatory IV and LVEF ≤45% as assessed within the 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.
    •Ferritin <100 ug/l (absolute iron deficiency) or 100-300 ug/l with TSAT <20% (functional iron deficiency) within 4 weeks of initial screening visit.
    •Red cell folate and Vitamin B12 levels above the lower limit of normal according to local lab reference range within 4 weeks of initial screening visit (even if achieved with folate or vitamin B12 supplements).
    •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.
    •Known hypersensitivity to oral iron preparations.
    •Patients with rare hereditary galactose intolerance or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency.
    •Religious or other objections to bovine/animal products
    •Known active infection, inflammation, bleeding, malignancy and haemolytic anaemia.
    •History of chronic liver disease and/or AST >3 times the upper limit of the normal range within 4 weeks of initial screening visit, chronic lung disease with FEV1<50% predicted, myelodysplastic disorder, and known HIV/AIDS disease.
    •Known gastrointestinal disorder or malabsorption syndrome
    •Prior gastric surgery
    •Recipient of immunosuppressive therapy or renal dialysis.
    •Diabetes with estimated glomerular filtration rate < 30 mL/min/1.73m2 within 4 weeks of initial screening visit.
    •History of erythropoietin therapy in previous 30 days or scheduled for erythropoietin therapy or blood transfusion during duration of the study.
    •Unstable angina pectoris 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, breast-feeding, or planning to get pregnant.
    •Inability to comprehend study protocol
    •Parallel participation in another clinical trial
    E.5 End points
    E.5.1Primary end point(s)
    •6MWD at week 12 between patients randomised to Globifer Forte® and those allocated to placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12.
    E.5.2Secondary end point(s)
    •6MWD at week 12 between patients randomised to Globifer Forte® and those allocated to FeSO4.
    •DMT-1, FPN, and FLVCR2 expression on Caco-2 cells with sera from CHF patients.
    •Serum iron levels at 3 hours after oral Globifer Forte®, FeSO4, and placebo tablets.
    •Blood tests (e.g., iron status, NT-BNP, cytokines) at week 12.
    •Symptom status and quality of life (NYHA class, Kansas City Cardiomyopathy questionnaire [KCCQ], visual analogue fatigue scale) at week 12.
    •Cardiac structure and function on echo at week 12.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 12.
    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 No
    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 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 Yes
    E.8.2.3.1Comparator description
    Ferrous Sulphate
    E.8.2.4Number of treatment arms in the trial6
    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
    Database lock
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 60
    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 state60
    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)
    As per standard care
    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 Decision2016-01-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-28
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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