Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

Inflammatory Bowel Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017614
• Other study ID #: P-Monofer-IBD-01
• Secondary ID: EudraCT no 2009-
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2009
• Last updated: November 22, 2012
• Start date: October 2009
• Est. completion date: August 2012

Study information

• Verified date: November 2012
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: National Health ServiceUnited Kingdom: Research Ethics CommitteeIndia: Drugs Controller General of IndiaIndia: Ethics CommitteesAustria: Ethics committees and Competent Authorities
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 350
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Anemia, Iron-Deficiency
• Deficiency Diseases
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

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
• Iron Sulphate
200 mg daily

Locations

Country	Name	City	State
Denmark	Research Site	Aalborg
Denmark	Research Site	Århus
Denmark	Research Site	Copenhagen
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
United Kingdom	Research Site	London

Sponsors (2)

Lead Sponsor	Collaborator
Pharmacosmos A/S	Max Neeman International

Countries where clinical trial is conducted

Denmark,  India,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hb concentration from baseline to week 8.		8 weeks	No
Secondary	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	No