Investigation of posaconazole prophylaxis in children with chronic granulomatous disease (CGD): pharmacokinetics and tolerability (iPOD). - iPOD

niversitair Medisch Centrum Sint Radboud0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•1. Patient has CGD, rendering him/her at risk for invasive fungal infections hence requiring antifungal prophylaxis.
•2. Patient is at least 2 years of age and younger than 17 years of age on the day of the first dosing.
•3. Parents or legal representative, and children where appropriate, willing and able to give informed consent.

•1. Patient is suspected of an invasive fungal infection.
•2. Therapy with any medicinal product for which an effect on posaconazol is expected (see Clinical Trial Protocol, appendix B, Table 1). If patient is undergoing therapy with any medicinal product which may be effected by posaconazol, the patient is included on condition that the investigator judges that the effects are not clinically relevant (see Clinical Trial Protocol, appendix B, Table 2). This should be clearly recorded.
•3. Documented history of sensitivity/idiosyncrasy to posaconazol.
•4. Results of serum biochemistry and hematology testing are not higher than 3x the upper limit of normal (see Clinical Trial Protocol, appendix A). If the results exceed these limits, the pa-tient is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly recorded.
•5. Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.
•6. Relevant history or presence of cardiovascular disorder or renal and hepatic dis-order.
•7. History of or current abuse of drugs, alcohol or recreational substances.
•8. Participation in a trial with an investigational drug within 60 days prior to the first dose.

发起方

niversitair Medisch Centrum Sint Radboud