- 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 12 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 \<2 g/dL) in the 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 (except correction 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.
Iron Deficiency
Maintenance Treatment of Iron Deficiency in IBD Patients
NCT00810004 | PHASE 3 | INTERVENTIONAL
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.
Trial Information
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State Scientific Center of Coloproctology of RosMedTekhnolgy
Moscow,Russian Federation,123423
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov