FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vifor Inc.; Vifor Pharma
• Collaborators: ClinStar, LLC; Parexel
• Treatments: Ferric Compounds; Ferric Oxide, Saccharated; Iron

Criteria

Inclusion Criteria

• Signed informed consent.

• Patients ≥18 years of age suffering from mild IBD (CD/UC) or in remission (mild IBD defined as CDAI score <220, or CAI score ≤7, remission defined as CDAI score <150, or CAI score ≤4).

• Hb 7-12 g/dL (female) or 7-13 g/dL (male).

• Ferritin <100 μg/L.

• Normal levels of vitamin B12 and folic acid.

• Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.

Exclusion Criteria

• Chronic alcohol abuse (alcohol consumption >20 g/day).

• Presence of portal hypertension with oesophageal varices.

• History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 4 weeks prior to screening.

• Known hypersensitivity to FERINJECT®.

• History of acquired iron overload.

• Myelodysplastic syndrome.

• Pregnancy or lactation.

• Known active infection, clinically significant overt bleeding, active malignancy.

• Known chronic renal failure. Vifor Pharma - Vifor (International) Inc Clinical Study Protocol inc. Amendments 1 and 2 Protocol Number: 93842, FER-IBD-07-COR CONFIDENTIAL Final 20 of 48 10 December 2008

• Surgery with relevant blood loss (defined as Hb drop <2 g/dL) in the last 3 months prior to screening or planned surgery within the following 3 months.

• Chronic liver disease or increase of liver enzymes (alanine aminotransferase ([ALT], aspartate aminotransferase [AST]) >3 times the upper limit of normal range.

• Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.

• Inability to fully comprehend and/or perform study procedures in the investigator's opinion.

• Participation in any other interventional study within 1 month prior to screening.

• Body weight <35 kg.

• Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.