Ferinject® Assessment In GastRectomy Patients With Acute Isovolemic Anemia (FAIRY)

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate the efficacy of Ferinject® in improving acute isovolemic anemia after gastrectomy for gastric cancer in terms of Quality of life(QOL )and objective measures (Hb and iron parameters).

Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Center, Korea
• Treatments: Ferric Compounds

Criteria

Inclusion Criteria:

• ≥ 20 years old

• 7g/dl ≤ Hb < 10g/dl at 5 - 7 days after gastrectomy for gastric cancer

• signed written informed consent

Exclusion Criteria:

• a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient

• hypersensitivity to any component of the formulation

• active severe infection/inflammation

• History of transfusion, erythropoietin, > 500 mg intravenous iron administration within 4 weeks prior to screening.

• History of acquired iron overload.

• Pregnancy or lactation.

• Decreased renal function (defined as creatinine clearance < 50 mL/min calculated by Cockcroft-Gault)

• Chronic liver disease or increase of liver enzymes (ALT, AST) > 3 times the upper limit of normal range.

• Participation in any other interventional study within 1 month prior to screening.