ACTRN12624000147583尚未招募1 期
A Randomized, Double-Blind, Multicentre, Parallel, Two-Arm, Therapeutic Equivalence Study comparing Iron (III) Hydroxide Polymaltose 100mg Hard Gelatin Capsules to Maltofer® 370 mg Tablets (100mg iron as iron polymaltose) in the treatment of Iron Deficiency Anaemia in Pregnant and Non-Pregnant Women, and Men
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Adult male patients, Pregnant and non-pregnant patients aged 18 years and above with a diagnosis of iron deficiency anaemia on the screening day and willing to provide written informed consent/assent form to participate in the study.
- •Diagnosed iron deficiency anaemia based on 2 criteria:
- •a.Haemoglobin level below 110 g/L but should be above 60 g/L.
- •b.Serum ferritin level below 30 µg/L.
- •Patients must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
- •For pregnant patients: Females in their first and second trimesters of pregnancy will be considered.
- •For non-pregnant patients: Females and males diagnosed with iron deficiency anaemia are eligible.
- •Female patients of childbearing potential must have a negative urine pregnancy report and should follow abstinence or use contraceptive methods with a failure rate of < 1%.
排除标准
- •Administration of any iron-containing drugs during the last 3 months.
- •History of erythropoietin drug administration.
- •Hypersensitivity to iron therapy (both Oral and/or IV administration) and other components of the study drugs.
- •Hormone therapy (including the use of androgens/anabolic steroids) or administration of drugs that inhibit blood formation, less than 3 months before the start of the study.
- •History of severe allergic reactions or drug intolerance.
- •Fructose intolerance, glucose-galactose malabsorption syndrome, and sucrase-isomaltase deficiency.
- •Failure of iron therapy for iron-deficiency anaemia in a patient's past medical history.
- •Heme metabolism disorders (e.g., sideroachrestic anaemia, lead anaemia, thalassemia).
- •Iron overload including hemochromatosis and hemosiderosis.
- •Other causes of anaemia, apart from iron deficiency, including:
- •a.Haemolysis (determined as per analysis results at screening, or as per anamnestic data).
- •b.Vitamin B12 and folic acid deficiency (as per the screening data).
- •c.Chronic kidney disease (creatinine clearance at screening is below 90 ml/min (based on Cockcroft-Gault Formula)).
- •d.Systemic connective tissue diseases, chronic infectious diseases requiring regular therapy (as per the past medical history), and other conditions which may, in the investigator's opinion, be accompanied by anaemia of chronic diseases.
- •Dysfunction of the thyroid gland (based on the data obtained at screening).
- •Laboratory and clinical signs of an active inflammatory process for 10 days before screening.
- •AST, ALT, and total bilirubin levels exceeding the upper limit of normal 1.5 times and more.
- •Clinically apparent hypothyroidism, in the investigator's opinion.
- •Malignant diseases, including blood and lymphoid tissue disorders (leukaemia, Hodgkin disease, myelodysplastic syndrome, myeloma, etc.) at screening or in the past medical history, provided that the remission was less than 5 years before screening.
- •Signs of bone marrow aplasia at screening or history of bone marrow aplasia.
- •The necessity of parenteral iron therapy, i.e., the following cases:
- •a.Impaired absorption in case of intestinal pathology (enteritis, celiac disease, malabsorption, small intestinal resection, stomach resection, including the duodenum).
- •b.Exacerbation of gastric or duodenal ulcer.
- •c.The necessity of quick iron saturation, e.g., in patients with iron deficiency anaemia with upcoming surgery.
- •d.Continuous vast blood loss and other causes, at the discretion of the investigator.
- •e.Sickle cell anaemia
- •Known presence of an active infection caused by Helicobacter pylori. In case of the presence of Helicobacter pylori, a patient may be enrolled after eradicative therapy.
- •Concomitant diseases and conditions, which, in the investigator's opinion, pose a risk to a patient's safety in case of his/her participation in the study, or able to affect the safety data analysis in case of exacerbation of this disease/condition during the study, including:
- •a.Myocardial infarction or stroke within 6 months before screening.
- •b.Unstable angina.
- •c.Severe arrhythmia, not controlled by drug therapy.
- •d.Decompensated diabetes mellitus.
- •e.Nephrological disorders.
- •Other significant diseases, at the discretion of the investigator.
- •For non-pregnant Patients: lactating women, or women intending to become pregnant during the study.
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