Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Disease	Drug: Monofer; Drug: Iron Sulphate	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	350 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Study Start Date :	October 2009
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	August 2012

Arms and Interventions

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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

Outcome Measures

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Primary Outcome Measures :

1. Change in Hb concentration from baseline to week 8. [ Time Frame: 8 weeks ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted:	November 20, 2009
Last Update Posted:	November 27, 2012
Last Verified:	November 2012

Keywords provided by Pharmacosmos A/S:

Inflammatory Bowel Disease; Iron deficiency; Iron deficiency anaemia; Anaemia

Additional relevant MeSH terms:

Anemia; Intestinal Diseases; Inflammatory Bowel Diseases; Anemia, Iron-Deficiency; Hematologic Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis	Anemia, Hypochromic; Iron Metabolism Disorders; Metabolic Diseases; Iron; Trace Elements; Micronutrients; Growth Substances; Physiological Effects of Drugs