An Open-label, Multicentre, Randomised, 2-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Pregnant Women
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 试验地点
- 20
- 主要终点
- Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
研究概览
简要总结
The purpose of this study is to look at how well Ferric Carboxymaltose, an intravenous iron therapy (iron that is infused directly into your body through a vein), compares with ferrous sulphate capsules taken by mouth in the treatment of iron deficiency anaemia during pregnancy.
详细描述
This is an open-label, multicentre, randomised, 2-arm study to assess the efficacy and safety of FCM compared to oral iron in pregnant women with IDA.
During the screening period (Days -10 to 0 before randomisation), subjects will be selected based on eligibility criteria. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will undergo baseline assessments at baseline (Day 0) prior to the first dose of study medication.
Subjects will be randomised to receive either intravenous (IV) iron (FCM, 1,000-1,500 mg) or oral iron (ferrous sulphate, 100 mg iron twice a day; total dose 200 mg/day).
The treatment period will begin with the infusion of FCM or the intake of oral iron on Day 0.
All subjects will return for assessment of efficacy and safety at Weeks 3, 6, 9, 12 and at delivery (or whichever comes first).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women aged ≥18, gestational week ≥20, ≤33 at baseline visit with normal antenatal screening test results.
- •Iron deficiency anaemia defined as Hb concentration ≥8 g/dl and ≤10.4 g/dL and serum ferritin ≤20 mcg/L at screening.
- •Demonstrated the ability to understand the requirements of the study, abide by the study restrictions, and agree to return for the required assessments. Patients (or their representative) must provide written informed consent for their participation in the study.
排除标准
- •Blood transfusion, erythropoietin treatment, parenteral iron or oral iron treatment (1 month prior to screening) or anticipated need for a blood transfusion during the study.
- •Anaemia not caused by iron deficiency (e.g., aplastic, megaloblastic or haemolytic anaemia) or related to acute or ongoing, haemoglobinopathies, rheumatic and other chronic diseases, autoimmune diseases, malignancies, bone marrow diseases, enzyme defects and drug induced anaemia.
- •Acute or chronic infection, clinically relevant active inflammatory disease (C-reactive protein >10 mg/dl or outside reference range), any acute infection at screening.
- •Pre-eclampsia.
- •Multiple pregnancy.
- •Evidence on any significant abnormalities on anomaly ultrasound.
- •Haemochromatosis or other iron storage disorders.
- •Folate deficiency (S-folate <4.5 nmol/L) at screening.
- •Vitamin B12 deficiency (S-cobalamin <145 pmol/L) at screening.
- •Serious medical condition, uncontrolled systemic disease or any other medical condition that, in the judgment of the Investigator, prohibits the patient from entering or potentially completing the study.
- •Known chronic renal failure (defined as creatinine clearance <30 mL/min calculated by Cockcroft-Gault or modification of diet in renal disease formula).
- •Severe cardiovascular diseases.
- •Known human immunodeficiency virus/acquired immunodeficiency syndrome, hepatitis B virus or hepatitis C virus infection.
- •Inability to fully comprehend and/or perform study procedures in the Investigator's opinion
- •History of endocrine disorders
- •Ongoing significant neurological or psychiatric disorders including psychotic disorders or dementia
- •Recent significant bleeding/surgery (within the 3 months prior to screening).
- •Chronic/acute hepatic disorder or elevating of liver enzymes (aspartate aminotransferase, alanine aminotransferase) over 2 times above the upper normal limit at screening.
- •Participation in any other interventional study since estimated conception and throughout study participation.
- •Known hypersensitivity to FCM or other IV iron preparations.
研究组 & 干预措施
Ferric carboxymaltose
Subjects with bw ≥66 kg will receive an infusion of 1,000 mg iron as FCM and after 1 week a further 500 mg iron as FCM, depending on Hb at screening.
subjects with bw <66 kg, 2-3 infusions of 500 mg iron as FCM will be administered within 2 weeks from baseline, depending on Hb at screening
干预措施: Ferinject (Drug)
Oral Iron
Oral Iron oral iron preparation will be provided at 200 mg iron per day in a convenient dosage schedule.
干预措施: ferrous sulphate (Drug)
结局指标
主要结局
Average Hb increase after 3 weeks in FCM compared to oral iron treated subjects (superiority).
时间窗: 3 weeks after baseline
次要结局
- Change in Hb from baseline at Week 6(6 weeks after baseline)
- Change in Hb from baseline at Week 9(9 weeks after baseline)
- Change in Hb from baseline at Week 12(12 weeks after baseline)