NCT03371173终止3 期
A Pilot Study to Explore Preliminary Safety, Tolerability and Efficacy of ORal IrON Supplementation With Ferric Maltol in Treating Iron Deficiency in Patients With Pulmonary Hypertension and Iron Deficiency Anemia
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in hemoglobin level from baseline to week 12
研究概览
简要总结
This is an explorative, open-label, uncontrolled, single center study to explore the preliminary safety, tolerability and efficacy of oral ferric maltol in treating iron deficiency in patients with pulmonary hypertension and iron deficiency anemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent prior to any study-related procedure and willingness to comply with treatment and follow-up procedures
- •Male and female patients ≥18 years at day of inclusion
- •Patients capable of understanding the investigational nature, potential risks and benefits of the clinical trial
- •Patients with a diagnosis of PH confirmed by a (historical) right heart catheterization showing a mean pulmonary artery pressure ≥25 mmHg at rest and stable PH medication for at least 3 months.
- •6 min walk distance >50 m
- •Mild-to-moderate iron-deficiency anemia as defined by a hemoglobin concentration ≥7 g/dl and <12 g/dl in females or ≥8 g/dl and <13 g/dl in males, and serum ferritin <100 µg/l, or 100-300 µg/l and transferrin saturation <20% at screening
- •Prevention of pregnancy:
- •Women without childbearing potential defined as follows:
- •at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy or
- •hysterectomy or uterine agenesis or
- •≥ 50 years and in postmenopausal state ≥ 1 year or
- •< 50 years and in postmenopausal state ≥ 1 year with serum FSH > 40 IU/l and serum oestrogen < 30 ng/l or a negative oestrogen test or
- •Women of childbearing potential with a negative ß-HCG pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of four weeks following the last administration of study medication:
- •correct use of contraception methods. The following are acceptable: hormonal contraceptives (combined oral contraceptives and oestrogen-free pills with desogestrel, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUS) or a barrier method, e.g. condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
- •true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
- •sexual relationship only with female partners and/or sterile male partners
排除标准
- •Active hematological disorders other than iron-deficiency anemia
- •Other medical condition that according to the investigator's assessment is causing or contributing to anemia
- •Active malignancy
- •Active infectious disease
- •Active bleeding
- •Severe renal insufficiency (glomerular filtration rate <30 ml/min)
- •Severe liver injury as indicated by serum aminotransferases >3 x upper limit of normal or bilirubin levels >50 µmol/l
- •Ongoing oral or intravenous iron supplementation
- •Hemoglobin <7 g/dl in females or <8 g/dl in males at screening
- •Concomitant erythropoietin medication
- •Pregnancy or lactation period
- •Subject has received any investigational medication or any investigational device within 30 days prior to the first dose of study medication or is actively participating in any investigational drug/devices trial, or is scheduled to receive an investigational drug/device during the course of the study.
- •Known or suspected hypersensitivity to any of the active substances or any excipients of the investigational medicinal product
- •Known haemochromatosis or other iron overload syndromes
- •Patients who have been receiving repeated (>1) blood transfusions during the past 6 months
研究组 & 干预措施
Ferric maltol 30 mg (Feraccru®)
Experimental
Treatment with Feraccru® 30 mg hard capsules (Ferric maltol 30 mg). One capsule twice daily, morning and evening, on an empty stomach for 12 weeks
干预措施: Ferric maltol 30 mg (Feraccru®) (Drug)
结局指标
主要结局
Change in hemoglobin level from baseline to week 12
时间窗: baseline to week 12
measurement of hemoglobin in blood
次要结局
- Change in echocardiographic markers of right ventricular function from baseline to week 12 (2)(from baseline to week 12)
- Change in World Health Organization Functional Class (WHO FC) from baseline to week 6 and week 12(from baseline to week 6 and week 12)
- Change in transferrin saturation from baseline to week 6 and 12(baseline to week 6 and baseline to week 12)
- Change in serum ferritin levels from baseline to week 6 and 12(baseline to week 6 and baseline to week 12)
- Change in 6 min walking distance from baseline to week 12(baseline to week 12)
- Change in echocardiographic markers of right ventricular function from baseline to week 12 (1)(from baseline to week 12)
- Change in hemoglobin from baseline to week 6(baseline to week 6)
- Change in serum NT-proBNP from baseline to weeks 6 and 12(baseline to week 6 and baseline to week 12)
- Change in echocardiographic markers of right ventricular function from baseline to week 12 (3)(from baseline to week 12)
- Change in echocardiographic markers of right ventricular function from baseline to week 12 (4)(from baseline to week 12)
研究者
研究点 (1)
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