NCT02410213已完成2 期
A Multi-center, Open-label, Single Arm Study to Characterize the Pharmacokinetics and Pharmacodynamics Profile of Intravenous Ferric Carboxymaltose in Pediatric Subjects 1-17 Years Old With Iron Deficiency Anemia (IDA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 10
- 主要终点
- Maximum Serum Concentration (Cmax)
研究概览
简要总结
This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15 mg/kg dose of Ferric Carboxymaltose.
详细描述
This is a Phase II, open-label, non-randomized, multi-center, single arm study to characterize the pharmacokinetic and pharmacodynamics (PK/PD) profile of Ferric Carboxymaltose dosing in pediatric subjects with IDA after receiving either a 7.5 mg/kg or 15 mg/kg dose of Ferric Carboxymaltose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects 1 to 17 years of age with assent to participation and his/her parent or guardian is willing and able to sign the informed consent approved by the Independent Review Board / Ethics Committee.
- •Screening TSAT < 20%
- •Screening Hemoglobin < 11 g/dL
- •For subjects who are receiving an erythropoietin stimulating agent (ESA): stable ESA therapy (+/- 20% of current dose) for > 8 weeks prior to the qualifying screening visit and no ESA dosing or product changes anticipated for the length of the trial
排除标准
- •Known hypersensitivity reaction to any component of Ferric Carboxymaltose.
- •Subject previously randomized and treated in this study or any other clinical study of Ferric Carboxymaltose (FCM or VIT-45).
- •Body mass index (BMI) ≤ 5th percentile for age (see APPENDIX 2)
- •Male or Female subject 1 year of age weighing < 12kg.
- •History of acquired iron overload, hemochromatosis or other iron accumulation disorders.
- •Chronic kidney disease subjects on hemodialysis.
- •Screening Ferritin level > 300ng/mL
- •Subjects with significant severe diseases of the liver, hemopoietic system, cardiovascular system, psychiatric disorder or other conditions which on the opinion of the investigator may place a subject at added risk.
- •Any active infection.
- •Known positive hepatitis B antigen (HBsAg) or hepatitis C viral antibody (HCV) with evidence of active hepatitis.
- •Known positive HIV-1/HIV-2 antibodies (anti-HIV).
- •Anemia due to reasons other than iron deficiency (i.e. hemoglobinopathy). Subjects treated with vitamin B12 or folic acid deficiency are permitted.
- •Intravenous iron and /or blood transfusion in the 4 weeks prior to screening.
- •Immunosuppressive therapy that may lead to anemia (i.e. cyclophosphamide, azathioprine, mycophenolate mofetil). Note steroid therapy is permitted.
- •Administration and / or use of an investigational product (drug or device) within 30 days of screening.
- •Alcohol or drug abuse within the past six months.
- •Female subjects who are pregnant or lactating, or sexually active female who are of childbearing potential not willing to use an acceptable form of contraceptive precautions during the study.
- •Subject is unable to comply with study assessments.
研究组 & 干预措施
Ferric Carboxymaltose (FCM)
Experimental
FCM at 7.5 mg/kg or 15 mg/kg to a maximum single dose of 750 mg iron, whichever is smaller
干预措施: Ferric Carboxymaltose (FCM) (Drug)
结局指标
主要结局
Maximum Serum Concentration (Cmax)
时间窗: prior to dosing and 1, 2, 6, 12, 48 and 72 hours post dosing
Maximum observed serum concentration; obtained directly from the serum concentration-time profile.
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
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