Maintenance Treatment of Iron Deficiency in IBD Patients
NCT ID: NCT00810004
Last Updated: 2012-12-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
245 participants
INTERVENTIONAL
2009-02-28
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ferinject
Intravenous infusion of iron
Ferinject
Intravenous infusion of iron
Placebo
NaCL 0,9%
Ferinject
Intravenous infusion of iron
Interventions
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Ferinject
Intravenous infusion of iron
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Vifor Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Christoph Gasche, Professor
Role: PRINCIPAL_INVESTIGATOR
Medical University of Vienna
Locations
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State Scientific Center of Coloproctology of RosMedTekhnolgy
Moscow, , Russia
Countries
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References
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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.
Other Identifiers
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FERGI-MAIN
Identifier Type: -
Identifier Source: org_study_id