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    Summary
    EudraCT Number:2010-024585-22
    Sponsor's Protocol Code Number:WILK3
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2011-02-25
    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 number2010-024585-22
    A.3Full title of the trial
    What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    What is the effect of intravenous iron supplementation on cardiopulmonary haemodynamics, exercise capacity and quality of life in patients with IPAH and iron deficiency?
    A.3.2Name or abbreviated title of the trial where available
    Ferinject® for iron deficiency in IPAH patients
    A.4.1Sponsor's protocol code numberWILK3
    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 SponsorImperial College Academic Healthsciences Centre
    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 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 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 nameFerinject
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.9.4EV Substance CodeAS1
    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) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    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 Information not present in EudraCT
    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 No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    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
    Idiopathic or familial pulmonary arterial hypertension
    E.1.1.1Medical condition in easily understood language
    Idiopathic or familial pulmonary arterial hypertension
    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 PT
    E.1.2Classification code 10037400
    E.1.2Term Pulmonary hypertension
    E.1.2System Organ Class 10038738 - Respiratory, thoracic and mediastinal disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the clinical value of using intravenous iron (ferric carboxymaltose) infusion in iron deficient patients with idiopathic pulmonary arterial hypertension.

    The primary endpoint will be the change in the resistance to blood flow through the lungs (resting pulmonary vascular resistance), measured by cardiac catheterisation at baseline and 12 weeks after the initial infusion.
    E.2.2Secondary objectives of the trial
    It is possible that iron may have beneficial effects via mechanisms not directly related to the blood flow through the lungs. Capturing other data, particularly exercise capacity, on the study participants is therefore essential. These non-invasive tests will be repeated to detect evidence of early benefit (at 2 weeks) as well as to follow serial changes in exercise capacity and iron status (at 12, 14, and 24 weeks after the initial infusion).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    We have carefully chosen the following entry criteria to clearly define our study group and reduce the potential for variation.

    1. Males or females aged between 16–75 years old
    2. PAH which is idiopathic, heritable or associated with anorexogens.
    3. Iron deficiency as defined by any one of the following criteria:
    sTfR levels > 28.1 nmol/l (where sTfR analysis is available) or one of the following: Ferritin < 37 ug/l; transferrin saturations < 16.4%; iron < 10.3 umol/l.
    4*. Documented diagnosis of PAH by right heart catheterisation performed at any time prior to Screening showing: resting mean pulmonary artery pressure >25mmHg, pulmonary capillary wedge pressure =/< 15 mm Hg and normal or reduced cardiac output.
    5. Six minute walking distance greater than 150m at entry;
    6. Stable on an unchanged PAH therapeutic regime (any combination of endothelin receptor antagonist, phosphodiesterase inhibitor or prostacyclin analogue) for at least 1 month.
    7. Able to provide written informed consent prior to any study-mandated procedures.
    8. Female subjects of child-bearing potential are eligible to participate if they agree to use one of the following contraception methods:
    - Abstinence
    - Contraceptive methods with a failure rate of < 1%:
    - Oral contraceptive, either combined or progestogen alone;
    - Injectable progestogen;
    - Implants of levonorgestrel;
    - Estrogenic vaginal ring;
    - Percutaneous contraceptive patches;
    - Intrauterine device (IUD) or intrauterine system (IUS) that meets the <1% failure rate as stated in the product label;
    - Male partner(s) sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study;
    - Double barrier method: condom and occlusive cap (diaphragm or cervical/vault caps) plus vaginal spermicidal agent (foam/gel/film/cream/suppository).

    *Patients who have not had a cardiac catheterisation prior to screening, but meet all other inclusion/exclusion criteria will be considered for the study if the clinical diagnosis is in keeping with idiopathic pulmonary arterial hypertension (IPAH). Inclusion of such patients should be discussed with the CI. These patients will be excluded at baseline if during the right heart catheterisation (RHC) the following criteria are not met: resting mean pulmonary artery pressure > 25mm Hg, pulmonary capillary wedge pressure =/< 15 mm Hg and normal or reduced cardiac output.
    E.4Principal exclusion criteria
    1. Unable to provide informed consent.
    2. Clinically-significant renal disease (Creatinine clearance < 30 ml/min per 1.73 m2 calculated from CKD-Epi http://www.qxmed.com/renal/Calculate-CKD-EPI-GFR.php) or liver disease (including serum transaminases > 3 times upper limit of normal).
    3. Haemoglobin concentration <10 g/dl.
    4. Patients who meet any of the following criteria will be excluded:
    Iron>27 umol/L, Ferritin>300 ug/L or Transferrin saturations >45%
    5. Patients with moderate to severe hypophosphatemia as defined as <0.65mmol/L
    6. Known to have haemoglobinopathy e.g. sickle cell disease, thalassaemia.
    7. Admission to hospital related to PAH or change in PAH therapy within 1 month prior to Screening.
    8. Evidence of left ventricular disease or significant lung disease on high-resolution CT scanning or lung function.
    9. Acute or chronic infection or inflammation.
    10. Significant uncontrolled asthma as judged by the investigator, eczema or atopic allergies.
    11. Females who are lactating or pregnant.
    12. Individuals known to have HIV, Hepatitis B or C or Creutzfeldt-Jakob disease.
    13. Known hypersensitivity to Ferinject® or any of its excipients.
    14. Evidence of disturbances in utilisation of iron.
    15. Significant blood loss (e.g. GI bleed) within the last 3 months or history of menorrhagia.
    16. Unable to perform a Cardiopulmonary Exercise Test i.e. due to syncope or musculoskeletal factors.
    17. Patients who have received an investigational medicinal product within 30 days of entering the baseline visit
    E.5 End points
    E.5.1Primary end point(s)
    The change in resting pulmonary vascular resistance (PVR) between baseline and 12 weeks, measured by cardiac catheterisation.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    E.5.2Secondary end point(s)
    • Incremental bicycle cardiopulmonary exercise testing - peak VO2 (ml/min/kg), VO2 at metabolic threshold, VE/VCO2 slope, VO2/WR slope, O2 pulse and tissue oxygenation index (at Hammersmith Site).
    • Endurance time on bicycle cardiopulmonary exercise test at 80% peak work rate, with measurement of steady-state gas exchange and tissue oxygenation index (Hammersmith Site only) at 3 minutes and peak
    • Resting cardiopulmonary haemodynamics – right atrial pressure, pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output and stroke volume
    • Exercise cardiopulmonary haemodynamics (at a work rate equivalent to 40% peak VO2) - pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output and stroke volume
    • Iron indices – serum iron, transferrin saturations, ferritin, soluble transferrin receptor (sTfR), unsaturated iron binding capacity (UIBC), red cell distribution width (RDW) and erythropoietin (EPO) levels
    • 6 minute walk distance and Borg dyspnoea scale
    • NYHA WHO functional class
    • NT-pro-BNP
    • Quality of life (CAMPHOR questionnaire) and the self-reported Patient Global Assessment
    • Safety - the occurrence of adverse events
    • Cardiac MRI - right ventricular volumes, mass, ejection fraction, stroke volume and diastolic function (at Hammersmith and Sheffield only)
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    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
    The last visit of the last subject undergoing the trial
    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
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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 Information not present in EudraCT
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 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)
    The crossover design of the study ensures that all participants will receive the maximum licensed dose for a single intravenous bolus of ferric carboxymaltose. If clinical need dictates, patients may receive further doses of ferric carboxymaltose, as appropriate to their level of iron deficiency, once the study has been completed.
    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 Decision2011-03-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-24
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-12-22
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