A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis - Intravenous iron in adults with cystic fibrosis

niversity of Oxford / Clinical Trials and Research Governance0 个研究点目标入组 20 人开始时间: 2019年6月20日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•- Age =18 years
•- Established diagnosis of cystic fibrosis
•- Iron deficiency (transferrin saturation =16 % or ferritin <15 µg/l, within last four months)
•- Able to provide informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 18
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 2

•- Urgent (<6 weeks) need for intravenous iron
•- Active infection (currently requiring IV antibiotics)
•- Previous intravenous iron supplementation (within last four months)
•- Current oral supplementation
•- Hypersensitivity to ferric carboxymaltose
•- Active non-tuberculous mycobacterial pulmonary disease (as defined by ATS-IDSA criteria)
•- Liver failure
•- Ferritin >300 g/l or transferrin saturation >45%
•- Pregnancy or breast feeding
•- Previous transplantation
•- Judged by a designated member of the trial team to be unlikely to comply with safety aspects of the trial protocol.

发起方

niversity of Oxford / Clinical Trials and Research Governance