NCT01895205已完成3 期
A Randomized Comparative, Open-Label Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by High Single Dose In-fusions or Red Blood Cell Transfusion in Women With Severe Postpartum Iron Deficiency Anaemia
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Physical Fatigue
研究概览
简要总结
The primary purpose of this study is to get explorative information about IV high single dose infusion of iron isomaltoside 1000 compared to RBC transfusion in the treatment of severe PP-IDA evaluated as physical fatigue
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
- Female
- 接受健康志愿者
- 否
入选标准
- •PPH > 1000 mL
- •Hb ≥ 5.5 and ≤ 8.0 g/dL (≥ 3.5 and ≤ 5.0 mmol/L)
- •Willingness to participate and signed the informed consent form
排除标准
- •Women aged < 18 years
- •Multiple births
- •Peripartum RBC transfusion
- •Known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
- •Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- •Women with a history of active asthma within the last 5 years or a history of multiple allergies
- •Known decompensated liver cirrhosis and active hepatitis
- •Women with HELLP (Haemolysis Elevated Liver enzymes Low Platelet count) syndrome (defined according to "Dansk Selskab for Obstetrik og Gynækologi guidelines")
- •Active acute infection assessed by clinical judgement
- •Rheumatoid arthritis with symptoms or signs of active joint inflammation
- •History of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency)
- •Not able to read, speak and understand the Danish language
- •Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline
- •Any other medical condition that, in the opinion of Investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. For example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
研究组 & 干预措施
Iron isomaltoside 1000
Experimental
A single dose of 1500 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9% sodium chloride and given over approximately 15 min.
干预措施: Iron isomaltoside 1000 (Drug)
Red blood cell transfusion
Active Comparator
Allogenic RBC transfusion is dosed to trigger Hb:
- Women with Hb 5.5 - 6.4 g/dL (3.5-3.9 mmol/L) will receive 2 units of RBC
- Women with Hb 6.5 - 8.0 g/dL (4.0-5.0 mmol/L) will receive 1 unit of RBC
干预措施: Red blood cell transfusion (Drug)
结局指标
主要结局
Physical Fatigue
时间窗: From exposure to 12 weeks post-exposure
次要结局
- Change in Hb concentration(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Number of adverse drug reactions (ADRs)(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Fatigue symptoms(from baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Change mean reticulocyte haemoglobin content (CHr)(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Change in p-ferritin(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Postpartum depression(From week 1 to 3, 8 and 12)
- Breastfeeding(From exposure to 12 weeks post-exposure)
- Change in p-iron(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Change in p-transferrin(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Change in transferrin saturation (TSAT)(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
- Change in reticulocyte count(From baseline to day 1, 2, 3, 4, 5, 6 and 7, week 3, 8 and 12)
研究者
相似试验
已完成
3 期
Treatment of Women After Postpartum HaemorrhagePostpartum HaemorrhageNCT01895218Pharmacosmos A/S200
已完成
3 期
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric PatientsFeverNCT01002573Cumberland Pharmaceuticals118
Unknown
4 期
The Efficacy and Safety of NALDEBAIN for the Treatment of Post-Laparotomy SurgeryPain, PostoperativeNCT03296488Kaohsiung Medical University Chung-Ho Memorial Hospital110
终止
4 期
A Study Comparing the Efficacy of Intravenous Followed by Oral Itraconazole With Intravenous Caspofungin For Empiric Antifungal Therapy in Neutropenic Participants With Hematological MalignancyHematologic NeoplasmsNCT02895529Xian-Janssen Pharmaceutical Ltd.61
已完成
1 期
Safety and Pharmacokinetics Study of Anthrax Immune Globulin Intravenous (AIGIV)AnthraxNCT00845650Emergent BioSolutions129