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Clinical Trials/EUCTR2011-003121-94-SE
EUCTR2011-003121-94-SEActive, not recruitingNot Applicable

A Prospective, Non-controlled, Safety Study of Intravenous Iron Isomaltoside 1000 (Monofer®) administered by a High Dosing Regimen in Subjects with Inflammatory Bowel Disease (PROMISE) - P-Monofer-IBD-02

Pharmacosmos A/S0 sites30 target enrollmentStarted: November 23, 2011Last updated:
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Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

Inclusion Criteria

  • •1. Subjects with age = 18 years
  • •2. Subjects diagnosed with IBD either in remission or active
  • •3. Hb < 12 g/dL for women and Hb < 13 g/dL for men
  • •4. Subjects with a CRP above upper limit of normality must have a ferritin below 100 µg/L, whereas subjects with a CRP below or equal to upper limit of normality must have a ferritin below 30 µg/L
  • •5. Willingness to participate after signing informed consent
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range

Exclusion Criteria

  • •1. Patient judged by the physician to be in need of surgery due to Crohn's disease or ulcerative colitis within the next 2 months
  • •2. Anaemia predominantly caused by factors other than IDA
  • •3. Iron overload or disturbance in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  • •4. Known hypersensitivity to any excipients of iron isomaltoside 1000
  • •5. History of multiple allergies
  • •6. Decompensated liver cirrhosis or active hepatitis (defined as Alanine Aminotransferase (ALAT) > 3 times upper limit of normal)
  • •7. Acute and/or chronic infections
  • •8. Body weight < 50 kg
  • •9. Rheumatoid arthritis with symptoms or signs of active joint inflammation
  • •10. Pregnancy and nursing. In order to avoid pregnancy, women have to be postmenopausal, surgically sterile, or use one of the following contraceptives during the whole study period and 5 days after the study has ended (i.e. 5 times plasma biological half-life of the investigational medicinal product): intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release)
  • •11. Blood transfusion within the previous 12 weeks
  • •12. Subjects with a history of asthma, allergic eczema, or other atopic allergy
  • •13. Planned elective surgery during the study
  • •14. Untreated Vitamin B12 or folate deficiency, defined as values below the lower reference range
  • •15. Participation in any other clinical study within 3 months prior to Screening
  • •16. IV iron treatment within 8 weeks prior to Screening
  • •17. Oral iron treatment within 1 week prior to Screening
  • •18. ESA treatment within 8 weeks prior to Screening
  • •19. 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

Investigators

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