Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01213680
First received: October 1, 2010
Last updated: November 13, 2013
Last verified: November 2013

October 1, 2010
November 13, 2013
February 2012
August 2012   (final data collection date for primary outcome measure)
Total serum iron pharmakokinetic parameters [ Time Frame: 24, 48 and72 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01213680 on ClinicalTrials.gov Archive Site
Total urine-iron pharmakokinetic parameters [ Time Frame: 24, 48 and 72 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease
Open-label Pharmakokinetic Study of Iron Isomaltoside 1000 (Monofer)Administered by 500 mg IV Injection or 1000 mg Intravenous Infusion to Patients With Inflammatory Bowel Disease (PK-IBD-02)

The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Inflammatory Bowel Disease
  • Drug: Monofer (iron isomaltoside 1000)
    1000 mg iron isomaltoside administered as a infusion over 15 minutes
  • Drug: Monofer
    500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes
  • Active Comparator: 1000 mg iron isomaltoside as intravenous infusion
    Intervention: Drug: Monofer (iron isomaltoside 1000)
  • Active Comparator: 500 mg iron isomaltoside 1000 as bolus injection
    Intervention: Drug: Monofer
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
November 2012
August 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men and women, aged more than 18 years
  2. Subjects diagnosed with inflammatory bowel disease and mild to moderate disease activity (defined as a score of less than or equal to 5 on the Harvey-Bradshaw index for Crohn's disease and a Mayo score (subscore without endoscopy) of less than or equal to 6 for ulcerative colitis)
  3. Weight above 50 kg
  4. Hb <12 g/dL (7.45 mmol/L)
  5. Transferrin saturation (TfS) <20%
  6. Life expectancy beyond 12 months by investigator's judgment
  7. Willingness to participate after informed consent -

Exclusion Criteria:

  1. Anaemia predominantly caused by other factors than iron deficiency anaemia
  2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  3. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate)
  4. Known hypersensitivity to any excipients in the investigational drug products
  5. Subjects with a history of multiple allergies
  6. Active Intestinal Tuberculosis
  7. Active intestinal amoebic infections
  8. Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) > 3 times upper limit normal)
  9. History of immunocompromise and/or history of Hepatitis B and/or C
  10. Acute infections (assessed by clinical judgment), supported by white blood cells (WBC) and C-reactive protein (CRP))
  11. Rheumatoid arthritis with symptoms or signs of active joint inflammation
  12. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), 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: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches)
  13. Extensive active bleeding necessitating blood transfusion
  14. Planned elective surgery during the study
  15. Participation in any other clinical study within 3 months prior to screening
  16. Untreated B12 or folate deficiency
  17. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit
  18. Erythropoietin treatment within 4 weeks prior to screening visit
  19. Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for the completion of the study or place the patient at potential risk from being in the study. Example: Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01213680
P-Monofer-PK-IBD-02, PK-IBD-02
No
Pharmacosmos A/S
Pharmacosmos A/S
Not Provided
Study Chair: Lars Lykke Thomsen, MD Pharmacosmos A/S
Pharmacosmos A/S
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP