An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF

eeds Teaching Hospital NHS Trust0 个研究点目标入组 12 人开始时间: 2007年3月28日最近更新: 2019年11月25日

试验速览

暂无简介。

•Confirmed cystic fibrosis according to the US Cystic Fibrosis Foundation guidelines
•Male or female subjects aged between 18 and 40 years;
•Hospitalised subject requiring routine intravenous antibiotic treatment;
•Written informed consent has been obtained;
•Pancreatic insufficiency as determined by a faecal elastase of <100µg g-1
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Known history or suspicion of alcohol or drug abuse;
•Pregnancy or breast-feeding female;
•Female subject of childbearing potential without adequate contraception;
•Participation in an investigational drug trial in the 30 days prior to selection;
•Known hypersensitivity to voriconazole or other azole (Fluconazole, Itraconazole, Ketoconazole, Ravuconazole, Posaconazole) antifungal agents;
•Known history of severe drug allergy or hypersensitivity;
•Has received systemic voriconazole within two weeks before study entry;
•Is receiving treatment with drugs that are contraindicated (See Concomitant therapy);
•Weight of less than 40kg
•Has liver disease defined as liver enzymes > twice the upper normal limit or bilirubin > 50mmol/l at trial entry;

发起方

eeds Teaching Hospital NHS Trust