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    Summary
    EudraCT Number:2008-004277-17
    Sponsor's Protocol Code Number:2008/2
    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:2010-03-15
    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 number2008-004277-17
    A.3Full title of the trial
    The effectiveness and tolerability of GlobiFer (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effectiveness and tolerability of GlobiFer (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.
    A.3.2Name or abbreviated title of the trial where available
    Oral haem to treat anaemia in patients with IBD
    A.4.1Sponsor's protocol code number2008/2
    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 SponsorGlobiFer International bvba
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Actavis FERROUS SULPHATE TABLETS BP 200mg
    D.2.1.1.2Name of the Marketing Authorisation holderActavis 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.3.1Product nameFerrous sulphate with 65 mg iron++ per tablet
    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 INNFerrous sulphate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.2.1.1.1Trade name GlobiFer Forte
    D.2.1.1.2Name of the Marketing Authorisation holderGlobiFer International bvba
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Information not present in EudraCT
    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 integrated haemolysed haemoglobin powderequal to 18 mg Fe++
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeGlobifer® Forte is based on bovine hemoglobin in combination with ferrous sulphate
    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
    Anaemia in inflammatory bowel disease
    E.1.1.1Medical condition in easily understood language
    Anaemia in inflammatory bowel disease
    E.1.1.2Therapeutic area Diseases [C] - Symptoms and general pathology [C23]
    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
    Treatment with Globifer Forte leads to better haemoglobin response compared to ferrous sulphate over 12 weeks
    E.2.2Secondary objectives of the trial
    I) The clinical effect of Globifer Forte is sustained over 24 weeks
    II) Globifer Forte is better tolerated than ferrous sulphate
    III) Globifer Forte is associated with fewer side effects and better adherence
    than ferrous sulphate
    IV) Iron supplementation (Haem or non-haem) exacerbates inflammatory
    bowel disease
    V) Globifer Forte causes a faster resolution of anaemia compared to ferrous
    sulphate
    VI) Globifer Forte has a different effect on the colonic microbiota of patients
    with IBD compared to ferrous sulphate.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with established inactive or mild to moderately active IBD. This is defined for patients with Crohn’s disease as CDAI≤220. For patients with ulcerative colitis a Simple Clinical Colitis Activity Index score of ≤8 defines inactive or mild-moderately active disease [Walmsley, 1998].
    Patients with a haemoglobin level at least 1g/dl below the sex specific lowest normal value (i.e. 13g/dl for men and 12g/dl for women; and either mean cell volume (MCV) ≤ 80 fl or ferritin ≤100 g/l or transferrin saturation <20% will be considered as having iron deficiency anaemia and offered iron intervention.

    All patients will be kept on their existing treatment for inflammatory bowel disease.
    E.4Principal exclusion criteria
    Patients with severe disease activity (defined as CDAI>220 for Crohn’s disease and CAI>8 for Ulcerative colitis) will be excluded. Patients with a history of intolerance of oral iron supplements will be excluded. Patients who have religious or other objections to the ingestion of bovine/animal products will not be recruited. Patients who decline to provide informed consent will also be excluded as will patients with decompensated liver cirrhosis, severe renal disease, severe psychiatric disorder, pregnancy or lactation or haemoglobinopathies. In addition, patients with severe symptomatic anaemia (i.e. shortness of breath, angina, heart failure, dyspnoea) will be excluded and receive treatment according to normal clinical practice (i.e. i.v. iron or blood transfusion). Patients with haemoglobin <7 will be excluded from oral iron therapy. Patients with abnormal low serum folate (<4µg/l) or vitamin B12 (<200ng/l) will be excluded. Patients with known malignancy will be excluded. Patients on current oral or intravenous iron supplementation will be excluded as will those who have had iron supplementation within the last 3 months.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients in each of the patient groups who achieve a 1g/dl increase in haemoglobin over baseline at 12 weeks.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 12
    E.5.2Secondary end point(s)
    Clinical assessment: At each visit the following will be measured in accordance with the Schedule of Assessments: FBC, serum ferritin, transferrin saturation, CRP, ESR, disease activity (CDAI or Simple Clinical Colitis Activity index) and QOL (IBDQ). A 10 point visual analogue scale will be used to assess fatigue.
    Patients will be asked to provide a stool sample at baseline, 12 weeks and 24 weeks. This will be frozen for later analysis of the microbiota.

    Safety of treatment: Symptoms and side effects will be assessed using a weekly diary card for the duration of the active treatment and the number of serious side effects will be recorded i.e. death, gastrointestinal side effects, increased disease activity. Adverse events will be recorded from the first intake of the study drug and serious adverse events will be followed up for 30 days after the last intake of study drug.
    E.5.2.1Timepoint(s) of evaluation of this end point
    see E.5.2
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 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.8.3 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 concerned3
    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 Information not present in EudraCT
    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
    Date of last person attending research clinic in connection with the trial
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    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)
    GlobiFer International bvba will make the new iron supplement available to all participants at no cost if treatment is required beyond the research term to ensure normalisation of haemoglobin.
    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 Decision2010-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-19
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