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

Afdeling Apotheek0 个研究点目标入组 10 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

Trial is onging in other countries

•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.

•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

Afdeling Apotheek