Iron deficiency anaemia in patients with inflammatory bowel disease MedDRA version: 9.1 Level: LLT Classification code 10055736 Term: Iron deficiency anaemia secondary to blood loss (chronic)
Conditions
Sponsors
Vifor (International) Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be entered into this study only if they meet all of the following criteria: • Signed informed consent. • Patients =18 years of age suffering from mild IBD (CD/UC) or in remission (mild IBD defined as CDAI score =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients will not be entered into this study if they meet any of the following 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. • Surgery with relevant blood loss (defined as Hb drop 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the non-inferiority in efficacy of a standardised dosage regimen of FERINJECT® compared to individually calculated dosage regimens of VENOFER® in the correction of IDA in patients with IBD in remission.;Secondary Objective: To evaluate the safety and tolerability of a standardised correction dose regimen of FERINJECT®.;Primary end point(s): Number of responders (Hb increase =2 g/dL) at Week 12. | — |
Countries
Austria, Denmark, Estonia, Germany, Lithuania, Spain, Sweden, United Kingdom
Outcome results
None listed