Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

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

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).

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Disease
• Intervention / Treatment: Drug: Monofer; Drug: Iron Sulphate

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: Interventional
• Enrollment (Anticipated): 350
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Aalborg, Denmark
    • Research Site
  • Copenhagen, Denmark
    • Research Site
  • Århus, Denmark
    • Research Site
• India
  • Hyderabad, India
    • Research Site
  • Jaipur, India
    • Research Site
  • Mumbai, India
    • Research Site
  • Nasik, India
    • Research Site
  • New Delhi, India
    • Research Site
  • Pune, India
    • Research Site
• United Kingdom
  • London, United Kingdom
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hb concentration from baseline to week 8.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	8 weeks

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S
• Collaborators: Max Neeman International
• Investigators: Study Chair: Pharmacosmos A/S, Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: November 19, 2009
• First Submitted That Met QC Criteria: November 19, 2009
• First Posted (Estimate): November 20, 2009

Study Record Updates

• Last Update Posted (Estimate): November 27, 2012
• Last Update Submitted That Met QC Criteria: November 22, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; Iron deficiency; Anaemia; Iron deficiency anaemia
• Additional Relevant MeSH Terms: Digestive System Diseases; Metabolic Diseases; Hematologic Diseases; Gastrointestinal Diseases; Gastroenteritis; Anemia, Hypochromic; Iron Metabolism Disorders; Inflammatory Bowel Diseases; Anemia, Iron-Deficiency; Anemia; Intestinal Diseases
• Other Study ID Numbers: P-Monofer-IBD-01; EudraCT no 2009-012544-16