Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2025-12-24 @ 8:00 PM
NCT ID:
NCT00810004
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00810004
Study Brief:
Protocol Section:
NCT00810004