Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
American Regent, Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects ≥ to 18 years of age and able to give informed consent.
Diagnosis of Iron Deficiency Anemia (IDA).
Hemoglobin (Hgb) ≤ to 11 g/dL.
Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
Must demonstrate an unsatisfactory response or intolerance to oral iron.
You may not be if
Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
Requires dialysis for treatment of chronic kidney disease.
No evidence of iron deficiency.
Any non-viral infection.
AST or ALT at screen 1, as determined by central labs, greater than 1.5 times the upper limit of normal.
Known positive hepatitis with evidence of active disease.
Received an investigational drug within 30 days of screening.
Alcohol or drug abuse within the past 6 months.
Hemochromatosis or other iron storage disorders.
Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
Any other laboratory abnormality, medical condition, or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Pregnant or sexually-active females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
