Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

This study has been completed.
Sponsor:
Collaborator:
Max Neeman International
Information provided by:
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01017614
First received: November 19, 2009
Last updated: November 22, 2012
Last verified: November 2012
  Purpose

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).


Condition Intervention Phase
Inflammatory Bowel Disease
Drug: Monofer
Drug: Iron Sulphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Change in Hb concentration from baseline to week 8. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: October 2009
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Monofer
  • administered as intravenous infusions (A1)
  • administered as intravenous bolus injections (A2)
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
Active Comparator: Iron Sulphate
tablets administered orally
Drug: Iron Sulphate
200 mg daily

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017614

Locations
Denmark
Research Site
Aalborg, Denmark
Research Site
Copenhagen, Denmark
Research Site
Århus, Denmark
India
Research Site
Hyderabad, India
Research Site
Jaipur, India
Research Site
Mumbai, India
Research Site
Nasik, India
Research Site
New Delhi, India
Research Site
Pune, India
United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Pharmacosmos A/S
Max Neeman International
Investigators
Study Chair: Pharmacosmos A/S Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark
  More Information

No publications provided

Responsible Party: Vice President, Clinical Development, Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01017614     History of Changes
Other Study ID Numbers: P-Monofer-IBD-01, EudraCT no 2009-012544-16
Study First Received: November 19, 2009
Last Updated: November 22, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee
India: Drugs Controller General of India
India: Ethics Committees
Austria: Ethics committees and Competent Authorities

Keywords provided by Pharmacosmos A/S:
Inflammatory Bowel Disease
Iron deficiency
Iron deficiency anaemia
Anaemia

Additional relevant MeSH terms:
Anemia
Inflammatory Bowel Diseases
Intestinal Diseases
Deficiency Diseases
Anemia, Iron-Deficiency
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Malnutrition
Nutrition Disorders
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Iron
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014