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    Summary
    EudraCT Number:2011-001593-25
    Sponsor's Protocol Code Number:P-Monofer-IBD-01-Extension
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-27
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2011-001593-25
    A.3Full title of the trial
    An Open-label, Multi-Centre, Non-Randomised Extension Study to Assess the Ability to Maintain a Stable Haemoglobin and to Assess Safety of Iron Isomaltoside 1000 (Monofer®) in Subjects with Inflammatory Bowel Disease
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This long-term follow-up study will assess the ability to maintain a stable haemoglobin (iron containing molecule in the blood) and safety profile of iron isomaltoside 1000 (Monofer®) in Inflammatory Bowel Disease subjects with iron deficiency anemia.
    A.4.1Sponsor's protocol code numberP-Monofer-IBD-01-Extension
    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 SponsorPharmacosmos A/S
    B.1.3.4CountryDenmark
    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 supportPharmacosmos A/S
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmacosmos A/S
    B.5.2Functional name of contact pointLene Heledie
    B.5.3 Address:
    B.5.3.1Street AddressRoervangsvej 30
    B.5.3.2Town/ cityHolbaek
    B.5.3.3Post code4300
    B.5.3.4CountryDenmark
    B.5.4Telephone number+4559485936
    B.5.5Fax number+4559485960
    B.5.6E-maillhe@pharmacosmos.com
    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.3.1Product nameMonofer
    D.3.2Product code B03AC06
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    Intravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIron isomaltoside complex - Iron Isomaltoside 1000
    D.3.9.1CAS number 9004-66-4
    D.3.9.2Current sponsor codeN.A.
    D.3.9.3Other descriptive nameIron Isomaltoside 1000
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Inflammatory bowel disease subjects with iron deficiency anaemia
    E.1.1.1Medical condition in easily understood language
    Anaemia due to lack of iron in patients that are suffering from Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis)
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10022972
    E.1.2Term Iron deficiency anaemia
    E.1.2System Organ Class 10005329 - Blood and lymphatic system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10021972
    E.1.2Term Inflammatory bowel disease
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To assess the long term efficacy of iron isomaltoside 1000 (Monofer®) by means of the ability to maintain stable Hb (defined as Hb ≥ 12.0 g/dL) in subjects with Hb ≥ 12.0 g/dL at the Baseline of Extension Study.
    2. To assess the ability to achieve stable Hb (Hb ≥ 12.0 g/dL) at Month 3 Visit of Extension Study, and then to maintain the stable Hb thereafter in subjects with Hb < 12.0 g/dL at Baseline of Extension Study.
    E.2.2Secondary objectives of the trial
    1. To assess the long term safety of iron isomaltoside 1000 (Monofer®) maintenance.
    2. To assess the dosage and frequency of additional iron isomaltoside 1000 (Monofer®), if administered.
    3. To assess the change in other relevant biochemical parameters (serum iron, serum ferritin, Total Iron Binding Capacity and Transferrin Saturation).
    4. To assess Quality of Life (QoL) by Inflammatory Bowel Disease Questionnaire (IBDQ).
    5. To assess the change in Restless Leg Syndrome (RLS) score by Cambridge-Hopkins RLS questionnaire (CH-RLSq) in subjects with RLS symptoms in Lead-in Study.
    6. To assess disease activity status using Harvey-Bradshaw Index for Crohn’s Disease or Partial Mayo Score (excluding Endoscopy Sub-score) for Ulcerative Colitis.
    7. To assess the change in platelet count.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completed the Lead-in Study or discontinued from Lead-in Study due to intolerance to oral iron.
    2. Life expectancy beyond 18 months by Investigator’s judgement.
    3. Willingness to participate after informed consent.
    E.4Principal exclusion criteria
    1. Discontinuation from Lead-in Study (except for due to intolerance to oral therapy).
    2. Any major protocol deviation in Lead-in Study.
    3. Pregnancy and nursing [To avoid pregnancy, women have to be postmenopausal, surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product (5 days): Contraceptive pills, Intrauterine Devices (IUD), contraceptive injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches].
    4. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study.
    5. Patients with a Harvey-Bradshaw Index > 8 or Partial Mayo Score (excluding Endoscopy Sub-score) > 6 at End of Study Visit of Lead-in Study.
    E.5 End points
    E.5.1Primary end point(s)
    1. Number of subjects (with Hb ≥ 12.0 g/dL at the Baseline of Extension Study) who maintain stable Hb (defined as Hb ≥ 12.0 g/dL) at all visits of the Extension Study.
    2. Number of subjects (with Hb ≥ 12.0 g/dL at Month 3 Visit of Extension Study) who maintain stable Hb (defined as Hb ≥ 12.0 g/dL) at all visits from Month 3 Visit of Extension Study in subjects with Hb < 12.0 g/dL at Baseline of Extension Study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3, 6, 9, 12 Visit
    E.5.2Secondary end point(s)
    1. Number of subjects who achieve stable Hb (Hb ≥ 12.0 g/dL) at any single visit.
    2. Number of consecutive visits for which stable Hb (Hb ≥ 12.0 g/dL) is maintained.
    3. Dosage of iron isomaltoside 1000 (Monofer®) re-administered, if required.
    4. Frequency of additional dosing of iron isomaltoside 1000 (Monofer®), if required.
    5. Change in concentrations of serum iron, serum ferritin, Total Iron Binding Capacity (TIBC) and Transferrin Saturation (TfS) from Baseline to End of Study of Extension Study.
    6. Change in total QoL score (IBDQ score) from Baseline to Month 6 and End of Study of Extension Study.
    7. Change in RLS symptoms by CH-RLSq score (in subjects with RLS symptoms in Lead-in Study) from Baseline to Month 6 and End of Study of Extension Study.
    8. Change in disease activity status using Harvey-Bradshaw Index for Crohn’s Disease, or Partial Mayo Score (excluding Endoscopy Sub-score) for Ulcerative Colitis from Baseline to Month 6 and End of Study of Extension Study.
    9. Number of subjects who experience any adverse drug reaction including any Suspected Unexpected Serious Adverse Event (SUSAR).
    10. Number of subjects who discontinue study because of lack of response or intolerance to investigational drug.
    11. Change in platelet count from Baseline to Month 6 and End of Study of Extension Study.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Month 3, 6, 9, 12 Visit
    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 No
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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 Yes
    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
    Pharmacosmos can temporarily suspend or prematurely discontinue this study at any time for reasons including, but not limited to, safety or ethical issues or severe non-compliance. This can occur at one or more or at all sites. The Principal Investigator also has the right to temporarily suspend or prematurely discontinue this study for mutually agreed reason(s) with the Pharmacosmos A/S.
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 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: 45
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    After the end of the study or if subject is withdrawn from the study, the subject will be treated according to standard hospital practice.
    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 Decision2012-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-07-11
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