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    Clinical Trial Results:
    The effectiveness and tolerability of GlobiFer Forte (haem iron) tablets compared to ferrous sulphate tablets in inflammatory bowel disease: a randomised-controlled trial.

    Summary
    EudraCT number
    		 2008-004277-17
    Trial protocol
    		 GB  
    Global end of trial date
    06 May 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Feb 2020
    First version publication date
    08 Feb 2020
    Other versions
    Summary report(s)
    		 End of Trial Report summary
    report

    Trial information

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    Trial identification
    Sponsor protocol code
    2008/2
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    GlobiFer Intl.
    Sponsor organisation address
    Satenrozen 6A unit 002, Kontich/Antwerp, Belgium, 2550
    Public contact
    General Manager, Patrick Swolfs, 38808772 38808772, ps@globiferintl.be
    Scientific contact
    General Manager, Patrick Swolfs, 38808772 38808772, ps@globiferintl.be
    Sponsor organisation name
    GlobiFer Intl
    Sponsor organisation address
    Satenrozen 6A unit 002, Kontich/Antwerp, Belgium, 2550
    Public contact
    Product Manager, Rabia Sarroukh , 0032 38808772, rs@globiferintl.be
    Scientific contact
    Product Manager, Rabia Sarroukh , 0032 38808772, rs@globiferintl.be
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    13 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 May 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To investigate if oral haem iron supplementation is more effective and better tolerated than non-haem iron in patients with inflammatory bowel disease over 12 weeks The current study aims to evaluate the effectiveness and acceptability of a new form of iron supplement GlobiFer (haem iron) against iron sulphate. GlobiFer Forte, the test preparation, is an iron supplement to offer both haem iron (protein-based iron) and non-haem iron (plant-based iron). Unlike other iron supplements, GlobiFer Forte provides two types of iron in one tablet for maximum absorption with virtually no gastric side effects. Iron can be enterically absorbed in haem or non-haem forms. Because haem iron uptake is thought to be less susceptible to inflammatory downregulation and less irritant to enterocytes, haem iron products are absorbed four times more efficiently and are better tolerated than non-haem preparations in healthy individuals.
    Protection of trial subjects
    GlobiFer Forte (active ingredient: Iron integrated haemolysed haemoglobin powderequal to 18 mg Fe++/tablet) was supplied as 900 mg tablets for oral intake twice daily with sufficient liquid. Batch Nos.: 911183, 102029, 320030, 320030, 420010 The main safety variables were the incidence and the severity of possible or probable adverse events and evaluation of laboratory tests. The analysis considered all events as documented in the CRFs. Symptoms and side effects are assessed using a weekly diary card for the duration of the active treatment and the number of serious side effects were recorded i.e. death, GI side effect, increased disease activity. Adverse events will be recorded form the first intake of the study drug and serious events will be followed up for 30 days after the last intake of study drug
    Background therapy
    		 An alternative approach to correcting iron deficiency anaemia is by the intravenous route. Iron sucrose has been extensively studied in patients with IBD and this has been found to be both safe and efficacious both alone and in combination with EPO. However, the use of intravenous iron is inconvenient, involving extra hospitals visits and can be uncomfortable.
    Evidence for comparator
    		 This above mentioned study was designed to test an alternative therapy for a better tolerated, safe and more effective iron supplementation than that which is currently available for IBD patients. The standard treatment for this (iron sulphate tablets) is commonly associated with gastro-intestinal side effects such as nausea, pain, diarrhoea or constipation. Oral non-haem iron supplementation is difficult in the context of IBD because patients with colitis seem to suffer the common gastrointestinal side effects of this medicine (nausea, bloating, pain, diarrhoea) more than iron deficient subjects without GI disease. Ferrous sulphate was supplied as 200 mg tablets for oral intake twice daily with sufficient liquid. In addition. Batch Nos.: FL2061, FM28, FM66, FT6, FT30, FT25
    Actual start date of recruitment
    19 May 2011
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    21
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    18
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was stopped due to unscheduled low recruitment.

    Pre-assignment
    Screening details
    		 Patients with established inactive or mild to moderately active IBD.

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    Patient have been provided with blister strips in numbered boxes by the manufacturer of GlobiFer forte who organized the randomization. Investigators and patient were not blinded to the treatment.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GlobiFer forte
    Arm description
    		 active ingredient: Iron integrated haemolysed haemoglobin powder equal to 18 mg elemental iron per tablet
    Arm type
    		 Experimental

    Investigational medicinal product name
    GlobiFer forte
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet and powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    36 mg elemental iron was supplied as 900 mg tablets for oral intake twice daily with sufficient liquid. Batch Nos.: 911183, 102029, 320030, 320030, 420010

    Arm title
    		 Ferrous Sulfate
    Arm description
    		 Ferrous iron equal to 65 mg elemental iron per tablet
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Ferrous sulfate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet and powder for oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    130 mg of ferrous sulfate was supplied as 200 mg tablets for oral intake twice daily with sufficient liquid. Batch Nos.: FL2061, FM28, FM66, FT6, FT30, FT25

    Number of subjects in period 1
    		GlobiFer forte Ferrous Sulfate
    Started
    11
    10
    Completed
    9
    9
    Not completed
    2
    1
         Adverse event, non-fatal
    1
    1
         Lost to follow-up
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 21 21
    Age categorical
    Units: Subjects
        16-29 years
    		 9 9
        30-39 years
    		 3 3
        40-49 years
    		 1 1
        50-59 years
    		 5 5
        >59 years
    		 3 3
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 12 12
    Race
    Part of the demographic data collected
    Units: Subjects
        Black-African
    		 1 1
        White
    		 14 14
        Asian
    		 5 5
        Other
    		 1 1

    End points

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    End points reporting groups
    Reporting group title
    GlobiFer forte
    Reporting group description
    		 active ingredient: Iron integrated haemolysed haemoglobin powder equal to 18 mg elemental iron per tablet

    Reporting group title
    Ferrous Sulfate
    Reporting group description
    		 Ferrous iron equal to 65 mg elemental iron per tablet

    Subject analysis set title
    Primary Efficacy criteria
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    GlobiFer arm : Achievement a 1g/dl increase in haemoglobin over baseline at 12weeks 56% no achievement a 1 g/dl increase in haemoglobin aver baseline at 12 weeks 44% Ferrous sulphate arm : Achievement a 1g/dl increase in haemoglobin over baseline at 12weeks 100% no achievement a 1 g/dl increase in haemoglobin aver baseline at 12 weeks 0%

    Subject analysis set title
    Secondary efficacy criteria
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    GlobiFer arm : Achievement a 1g/dl increase in haemoglobin over baseline at 24 weeks 100% no achievement a 1 g/dl increase in haemoglobin aver baseline at 24 weeks 0% Ferrous sulphate arm : Achievement a 1g/dl increase in haemoglobin over baseline at 24 weeks 88% no achievement a 1 g/dl increase in haemoglobin aver baseline at 24 week 13%

    Subject analysis set title
    Tolerance of study medication over baselines 24 weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    GlobiFer arm : Patient with AE - possible related 27.3% Patient without AE-possible related 72.7% Patient with AE - propable related 0% Patient without AE-probalbe related 100% Ferrous sulphate arm : Patient with AE - possible related 0% Patient without AE-possible related 100% Patient with AE - propable related 30% Patient without AE-probalbe related 100%

    Subject analysis set title
    Secondary efficacy criteria-AE over baselines at 24 weekds
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    GlobiFer arm : Patient with AE 100% Patient without AE 0% Patient with AE - not related 100% Patient without AE-not related 0% Patient with AE - possible related 27.3% Patient without AE-possible related 72.7% Patient with AE - probable related 0% Patient without AE-probable related 100% Ferrous sulphate arm : Patient with AE 80% Patient without AE 20% Patient with AE - not related 50% Patient without AE-not related 50% Patient with AE - possible related 0% Patient without AE-possible related 100% Patient with AE - probable related 30% Patient without AE-probable related 70%

    Subject analysis set title
    Adherence over baseline at 12 weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients n=21 97% SD 4% GlobiFer n= 9 95% Ferrous sulphate n=8 98%

    Subject analysis set title
    Resolution of anemia over baselines 12 weeks
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    all patients increase of haemoglobine (g/dl) 2.3 SD 1.4 GlobiFer increase of haemoglobine (g/dl) 1.5 SD 1.3 Ferrous sulphate increase of haemoglobine (g/dl) 3.1 SD 0.9

    Primary: Proportion of patients in each of the patient groups whoachieveda 1g/dl increase in haemoglobin over baseline at 12 weeks

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    End point title
    		 Proportion of patients in each of the patient groups whoachieveda 1g/dl increase in haemoglobin over baseline at 12 weeks
    End point description
    End point type
    Primary
    End point timeframe
    12weeks
    End point values
    		 GlobiFer forte Ferrous Sulfate
    Number of subjects analysed
    9
    8
    Units: number of person
    5
    8
    Statistical analysis title
    		 No statistical analysis
    Statistical analysis description
    due to the small number of patients and the inhomogeneous data situation does not allow a statement to compare the efficacy of the two drugs.
    Comparison groups
    GlobiFer forte v Ferrous Sulfate
    Number of subjects included in analysis
    17
    Analysis specification
    Post-hoc
    Analysis type
    		 other [1]
    P-value
    		 ≤ 0 [2]
    Method
    		 not applicable
    Parameter type
    		 not applicable
    Point estimate
    0
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 95
    Notes
    [1] - not applicable
    [2] - target not met, no statistical analysis done

    Secondary: Sustainability of 1g/dl increase in haemoglobin (baseline to 12 weeks) at 24 weeks

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    End point title
    		 Sustainability of 1g/dl increase in haemoglobin (baseline to 12 weeks) at 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    12 weeks
    End point values
    		 GlobiFer forte Ferrous Sulfate
    Number of subjects analysed
    5
    8
    Units: patient number
    5
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    weekly assessment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    no found
    Reporting groups
    Reporting group title
    All patients
    Reporting group description
    		 -

    Serious adverse events
    		 All patients
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 21 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All patients
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 21 (4.76%)
    Gastrointestinal disorders
    Abdominal pain lower
    Additional description: The subject present nausea and vomiting , headache syndromes, tinnitus , dizziness and giddiness experienced R sided abdominal pain and constipation, 57 days after receiving Globifer. The patient was treated for pain and constipation-faecal loading
         subjects affected / exposed
    1 / 21 (4.76%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Nov 2010
    inclusion of colonic microbiota- stool sample added to study design treatment 36 weeks to 24 weekds
    05 Aug 2011
    Study design per PI request to increase recruitment
    09 Dec 2011
    protocol to increase patient recruitment
    22 May 2013
    Inclusion criteria changes
    26 Feb 2014
    Sponsor contact changes
    01 Apr 2014
    enrollment is very low; protocol amended to increase the enrolment rate inclusion criteria exclusion criteria rescreening Trial design

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    06 May 2015
    Study was prematuraly ended because of recruitment status very low
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study was stopped due to unscheduled low recruitment. Due to the inhomogeneity of the patient population and the very low number of patients no statistical analysis was performed.
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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