CompletedPhase 1

Open-label PK Study of Iron Isomaltoside 1000 (Monofer) Administered by 500 mg IV Injection or 1000 mg IV Infusion to Patients With Inflammatory Bowel Disease

16 participantsStarted 2012-02

Plain-language summary

The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer(R)in patients suffering from inflammatory bowel disease

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Men and women, aged more than 18 years
✓. 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)
✓. Weight above 50 kg
✓. Hb \<12 g/dL (7.45 mmol/L)
✓. Transferrin saturation (TfS) \<20%
✓. Life expectancy beyond 12 months by investigator's judgment
✓. Willingness to participate after informed consent -

Exclusion criteria

✕. Anaemia predominantly caused by other factors than iron deficiency anaemia
✕. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
✕. Drug hypersensitivity (i.e. previous hypersensitivity to Iron Dextran or iron mono- or disaccharide complexes or to iron sulphate)
✕. Known hypersensitivity to any excipients in the investigational drug products
✕. Subjects with a history of multiple allergies
✕. Active Intestinal Tuberculosis
✕. Active intestinal amoebic infections
✕. Decompensated liver cirrhosis and hepatitis (Alanine Aminotransferase (ALT) \> 3 times upper limit normal)

What they're measuring

Total serum iron pharmakokinetic parameters

Timeframe: 24, 48 and72 hours

Trial details

NCT IDNCT01213680

SponsorPharmacosmos A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

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