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.

1 Sites

245 Participants

Recruiting

18 Years to 50 Years

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SUBMIT

State Scientific Center of Coloproctology of RosMedTekhnolgy

Moscow,Russian Federation,123423

Inclusion Criteria

* Aged 18 years or older at the time of providing written informed consent
* Diagnosis of malignancy that requires placement of a PICC within the next 3 weeks for administration of chemotherapy (PICC anticipated to be required for at least 1 month)
* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 \[Oken et al, 1982\], and investigator's expectation that performance status will remain 0, 1, or 2 for the duration of the study

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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