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| Name | Class |
|---|---|
| Parexel | INDUSTRY |
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The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferinject | Experimental | Intravenous infusion of iron |
|
| Placebo | Placebo Comparator | NaCL 0,9% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferinject | Drug | Intravenous infusion of iron |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of maintenance treatment of iron deficiency | 8 months |
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Inclusion Criteria
Non-anaemic patients treated in the FERGI-CORRECTION study (Hb ≥12 g/dL female, ≥13 g/dL male), independent of ferritin value.
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 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.
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Gasche, Professor | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Scientific Center of Coloproctology of RosMedTekhnolgy | Moscow | 123423 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23078888 | Derived | Evstatiev R, Alexeeva O, Bokemeyer B, Chopey I, Felder M, Gudehus M, Iqbal T, Khalif I, Marteau P, Stein J, Gasche C; FERGI Study Group. Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):269-77. doi: 10.1016/j.cgh.2012.10.013. Epub 2012 Oct 16. |
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| ID | Term |
|---|---|
| D000090463 | Iron Deficiencies |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
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| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |