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Iron Oligosaccharide in Inflammatory Bowel Disease Subjects With Iron Deficiency Anaemia

NCT ID: NCT01017614

Last Updated: 2012-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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).

Conditions

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Inflammatory Bowel Disease

Keywords

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Inflammatory Bowel Disease Iron deficiency Iron deficiency anaemia Anaemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Monofer

* administered as intravenous infusions (A1)
* administered as intravenous bolus injections (A2)

Group Type EXPERIMENTAL

Monofer

Intervention Type DRUG

* 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

tablets administered orally

Group Type ACTIVE_COMPARATOR

Iron Sulphate

Intervention Type DRUG

200 mg daily

Interventions

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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

Intervention Type DRUG

Iron Sulphate

200 mg daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Max Neeman International

UNKNOWN

Sponsor Role collaborator

Pharmacosmos A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Pharmacosmos A/S

Principal Investigators

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Pharmacosmos A/S

Role: STUDY_CHAIR

Pharmacosmos A/S, Roervangsvej 30, DK 4300 Holbaek, Denemark

Locations

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Research Site

Aalborg, , Denmark

Site Status

Research Site

Aarhus, , Denmark

Site Status

Research Site

Copenhagen, , Denmark

Site Status

Research Site

Hyderabad, , India

Site Status

Research Site

Jaipur, , India

Site Status

Research Site

Mumbai, , India

Site Status

Research Site

Nashik, , India

Site Status

Research Site

New Delhi, , India

Site Status

Research Site

Pune, , India

Site Status

Research Site

London, , United Kingdom

Site Status

Countries

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Denmark India United Kingdom

Other Identifiers

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EudraCT no 2009-012544-16

Identifier Type: -

Identifier Source: secondary_id

P-Monofer-IBD-01

Identifier Type: -

Identifier Source: org_study_id