A Randomized Patient -Blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject®) With Placebo in Patients With Acute Isovolemic Anemia After Gastrectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 454
- 试验地点
- 6
- 主要终点
- • Number of responders
研究概览
简要总结
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.
详细描述
Randomized patient-blind placebo controlled study. Hb level of 10 g/dl will be used as a cut-off value for our study based on the guidelines published by American Society of Clinical Oncology and the American Society of Hematology for the treatment of cancer-related anemia, recommending Hb<10 g/dl as a treatment threshold.
Ferinject® to be administered based on Hb and body weight per approved summary of product characteristics (SmPC).
5 - 7 days after gastrectomy for gastric cancer, consented patients with 7g/dl≤Hb<10g/dl will be administered Ferinject® or placebo (normal saline) based on the results of randomization.
• Study Group Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg .
Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight <50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value <15ng/mL at week 4 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 20 years old
- •7g/dl ≤ Hb < 10g/dl at 5 - 7 days after gastrectomy for gastric cancer
- •signed written informed consent
排除标准
- •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.
研究组 & 干预措施
Ferinject® Group
Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with 7g/dl≤Hb<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.
干预措施: Ferinject® (Drug)
Placebo Group
Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with 7g/dl≤Hb<10g/dl at 5 - 7 days after gastrectomy for gastric cancer.
干预措施: normal saline (Drug)
结局指标
主要结局
• Number of responders
时间窗: 12 weeks post baseline
• Number of responders (Hb increase ≥2 g/dL with respect to the baseline Hb value and/or Hb ≥11g/dL ) by 12 weeks (independent of alternative anaemia management including transfusion or ESA use). Note, if patient requires an ESA or blood transfusion by week 12 will be considered a non-responder.
次要结局
- • Percentage of patients with Hb ≥10, 11 and 12 g/dL(3weeks , 12 weeks post baseline)
- • Percentage of patients requiring alternative anaemia management therapy(12 weeks post baseline)
- • Self-reported patient assessment of EORTC QLQ C-30 and Sto-22(3weeks, 12weeks post baseline)
- • Evolution of Hb, ferritin and TSAT(12 weeks post baseline)
- • adverse events: type, nature, incidence and outcome(up to 3 weeks post baseline)
研究者
Young-Woo Kim
Head of Department of Gastric Cancer Research
National Cancer Center, Korea