Pharmacokinetics of posaconazole (Noxafil(R)) as prophylaxis for invasive fungal disease - PIRAÑA

Radboud University Medical Centre0 个研究点目标入组 27 人开始时间: 2016年7月20日最近更新: 2022年4月19日

试验速览

暂无简介。

•1.Subject is able and willing to sign the Informed Consent Form prior to screening evaluations.
•2.Subject is at least 18 years of age on the day of providing informed consent.
•3.Patient receives immunosuppressive therapy for acute GVHD, (non)myeloablative or reduced intensity conditioning regimens for SCT, or remission induction chemotherapy for AML/MDS.
•4.In case of acute GVHD grade II-IV, patient has received less than 1 week of immunosuppressive therapy.
•5.If a woman, is neither pregnant nor able to become pregnant and is not nursing an infant.
•6.Has an ALAT <200U/L, ALAT <225U/L, alkaline phosphatase <60 U/L and a bilirubin level <50 µmol/L.
•7.Subject is capable of receiving oral tablets.
•8.Subject is managed with a central venous or arterial catheter.
•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 20
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 10

•1.Documented history of sensitivity to medicinal products or excipients similar to those found in the posaconazole preparation.
•2.Relevant history or presence of cardiovascular disorders (specific QTc time prolongation).
•3.Inability to understand the nature of the trial and the procedures required.
•4.Any sign or symptoms of invasive fungal disease or the use of antifungal drugs within the previous month.
•5.Has previously participated in this trial.

发起方

Radboud University Medical Centre