NCT00982007已完成3 期
A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 997
- 试验地点
- 1
- 主要终点
- Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
研究概览
简要总结
The main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
研究组 & 干预措施
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
Experimental
Intravenous (IV) iron
干预措施: Ferric Carboxymaltose (FCM) (Drug)
Cohort 1 (Group B) - Ferrous Sulfate
Active Comparator
Oral iron - Ferrous Sulfate tablets
干预措施: Ferrous Sulfate Tablets (Drug)
Cohort 2 (Group D) - IV Iron (standard of care)
Active Comparator
Other IV iron
干预措施: IV Iron (standard of care) (Drug)
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
Experimental
Intravenous (IV) iron
干预措施: Ferric Carboxymaltose (FCM) (Drug)
结局指标
主要结局
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
时间窗: Day 35
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar StenosisLow Back PainLeg PainLumbar Spinal StenosisSpondylolisthesisNCT00405691Impliant, Ltd.450
终止
3 期
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-032)(TERMINATED)HIV InfectionNCT00443703Merck Sharp & Dohme LLC352
终止
3 期
MK0518 in the Treatment of HIV-Infected Patients Switched From a Protease Inhibitor Regimen (0518-033)(TERMINATED)HIV InfectionNCT00443729Merck Sharp & Dohme LLC355
已完成
3 期
An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (0431-024)Diabetes Mellitus, Type 2NCT00094770Merck Sharp & Dohme LLC1,172
Unknown
不适用
Study Evaluating the Safety and Efficacy of Tri-wire Balloon for Treatment of Dysfunctional AV FistulaArteriovenous FistulaNCT04393688BrosMed Medical Co., Ltd168