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Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

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ClinicalTrials.gov Identifier: NCT01017614
Recruitment Status : Completed
First Posted : November 20, 2009
Last Update Posted : November 27, 2012
Sponsor:
Collaborator:
Max Neeman International
Information provided by:
Pharmacosmos A/S

Tracking Information
First Submitted Date  ICMJE November 19, 2009
First Posted Date  ICMJE November 20, 2009
Last Update Posted Date November 27, 2012
Study Start Date  ICMJE October 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
Change in Hb concentration from baseline to week 8. [ Time Frame: 8 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01017614 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2009)
Number of subjects who achieve target limits of Hb (men 13-18 g/dL, women 12-16 g/dL) and have change in Hb concentration > 1.0 g/dL and have serum ferritin (100-800µg/L) and have achieved Transferrin saturation (TfS) (20-50 %) at week 2, 4 and 8. [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
Official Title  ICMJE A Phase III, Randomized, Comparative, Open-label Study of Intravenous Iron Oligosaccharide (Monofer®) Administered by Infusions or Repeated Bolus Injections in Comparison With Oral Iron Sulphate in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia
Brief Summary The purpose of the trial is to demonstrate that intravenous iron oligosaccharide is non-inferior to oral iron sulphate in reducing iron deficiency anaemia secondary to inflammatory bowel disease (IBD), evaluated as the ability to increase haemoglobin (Hb).
Detailed Description The study is designed to determine the effects of an investigational drug Monofer in subjects with Inflammatory Bowel Disease (IBD) (an intestinal disease characterized by swelling, redness and sometimes ulcers in intestine) and with Iron Deficiency Anaemia (IDA) (Anaemia is a condition characterized by deficiency of blood in the body).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Inflammatory Bowel Disease
Intervention  ICMJE
  • Drug: Monofer
    • administered as intravenous infusions (A1)repeated weekly until total iron repletion is obtained
    • administered as intravenous bolus injections (A2)as repeated bolus injections weekly until total iron repletion is obtained
  • Drug: Iron Sulphate
    200 mg daily
Study Arms  ICMJE
  • Experimental: Monofer
    • administered as intravenous infusions (A1)
    • administered as intravenous bolus injections (A2)
    Intervention: Drug: Monofer
  • Active Comparator: Iron Sulphate
    tablets administered orally
    Intervention: Drug: Iron Sulphate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: November 19, 2009)
350
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects with a diagnosis of IBD with iron deficiency anaemia will be included if they meet all of the following 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. Hb <12.0 g/dL (7.45 mmol/L).
  4. Transferrin saturation (TfS) <20 %.

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. Acute infections (assessed by clinical judgement), supplied with white blood cells (WBC) and C-reactive protein (CRP)).
  10. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
  11. Pregnancy and nursing
  12. Extensive active bleeding necessitating blood transfusion.
  13. Planned elective surgery during the study.
  14. Participation in any other clinical study within 3 months prior to screening.
  15. Intolerance to oral iron treatment.
  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. Erythropoetin treatment within 8 weeks prior to screening visit.
  19. Diagnosis of Hepatitis B and/or C, confirmed by appropriate lab test.
  20. 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.
  21. History of immunocompromise, including positive HIV test result
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark,   India,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01017614
Other Study ID Numbers  ICMJE P-Monofer-IBD-01
EudraCT no 2009-012544-16
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Vice President, Clinical Development, Pharmacosmos A/S
Study Sponsor  ICMJE Pharmacosmos A/S
Collaborators  ICMJE Max Neeman International
Investigators  ICMJE
Study Chair: Pharmacosmos A/S Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark
PRS Account Pharmacosmos A/S
Verification Date November 2012

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