A Study to Test the Non-Inferiority of Ferric Bepectate IV Against Ferric Carboxymaltose in Patients With Iron Deficiency Anemia

Ki vehet részt

• Male or female patient at least 18 years old at the time of screening
• Patients with general iron deficiency anaemia IDA
• Patients with serum ferritin levels ≤40 ng/mL inclusive
• Patients with haemoglobin (Hb) levels <10 g/dL
• Patients ≥ 35 kg body weight
• The patient has adequate hepatic and renal function defined as a serum aspartate aminotransferase or alanine aminotransferase level that are no more than 3 times the upper limit of the normal range, a serum bilirubin level that is no more than 2 times the upper limit of the normal range and a serum creatinine level of less than 2 mg/dL
• The patient is able to understand the protocol and provides informed consent to participate in the study

Ki nem vehet részt

• Patient is expected to require a blood transfusion within the study period or has had a blood transfusion within the 30 days prior screening
• Patient has undergone a surgical procedure during the 30 days prior to screening, and/or is expected to undergo a surgical procedure during the study period (screening - V5)
• Drug or alcohol abuse according to WHO definition
• Current or previous participation in another clinical trial during the last 90 days before screening
• The following concomitant treatments prescribed by a physician for non-iron deficiency anaemia (e.g., known vitamin B12 or folate deficiency), hemoglobinopathy, or unexplained anaemia are not allowed during the study and 24 weeks before screening: Erythropoiesis-stimulating agents, vitamin B12, Folic acid or other I.V. or oral iron products
• Patients with hemodynamic instability due to any ongoing bleeding. Absence of ongoing bleeding will be confirmed either by decision of two independent physicians or by removal of drainage whichever occurs earlier in routine care
• Primary hematologic disease
• Estimated life expectancy of <6 months or, for cancer patients, an Eastern Cooperative Oncology Group performance status >1
• Patients with life-threatening anaemia, defined as Hb < 6.5 g/dL
• Patients with any contraindication to the investigational products, e.g.,; known sensitivity to iron or an ingredient of the investigational products,; significant history of systemic allergic reactions,; hemochromatosis, thalassemia or TSAT >50% as indicator of iron overload,; acute or chronic intoxication,; infection (patient on non-prophylactic antibiotics),; chronic liver disease and/or screening ALT or AST above three times the upper limit of the normal range; chronic kidney disease, defined as GFR <30 mL/min
• Pregnant or breastfeeding patients
• Female patients not willing to use a safe method of contraception (PEARL index <1) for the full study (screening - V5)
• Severe physical inability, e.g., ASA physical status IV or V
• Non-iron deficiency anaemia, e.g., known Vitamin B12 or folate deficiency, hemoglobinopathy, or unexplained anaemia
• Anticipated medical need for erythropoiesis-stimulating agents during the study period (screening - V5)
• Potentially unreliable patients, and those judged by the investigator to be unsuitable for the study
• Exclusion criteria according to SmPC of Ferric Carboxymaltose