Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to find a dose for a twice daily regimen for posaconazole (PSZ) as prophylactic treatment in children with CGD, based on the PSZ trough level.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Treatments: Posaconazole

Criteria

Inclusion Criteria:

• Patient has CGD, rendering him/her at risk for invasive fungal infections hence requiring antifungal prophylaxis.

• Patient is at least 2 years of age and younger than 17 years of age on the day of the first dosing.

• Parents or legal representative, and children where appropriate, willing and able to give informed consent.

Exclusion Criteria:

• Patient is suspected of an invasive fungal infection.

• Therapy with any medicinal product for which an effect on PSZ is expected. If patient is undergoing therapy with any medicinal product which may be effected by PSZ, the patient is included on condition that the investigator judges that the effects are not clinically relevant. This should be clearly recorded.

• Documented history of sensitivity/idiosyncrasy to PSZ.

• Results of serum biochemistry and hematology testing are not higher than 3x the upper limit of normal. If the results exceed these limits, the patient is included on condition that the investigator judges that the deviations are not clinically relevant. This should be clearly recorded.

• Relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion.

• Relevant history or presence of cardiovascular disorder or renal and hepatic disorder.

• History of or current abuse of drugs, alcohol or recreational substances.

• Participation in a trial with an investigational drug within 60 days prior to the first dose.