Status:
COMPLETED
Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)
Lead Sponsor:
Radboud University Medical Center
Conditions:
Chronic Granulomatous Disease
Eligibility:
All Genders
2-16 years
Phase:
PHASE2
Brief 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.
Detailed Description
At this moment itraconazole is the drug of first choice in the prophylaxis of fungal infections in children with CGD. Breakthrough fungal infections while on itra-conazole prophylaxis are described in...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00799071
Start Date
February 1 2009
End Date
August 1 2010
Last Update
November 30 2020
Active Locations (2)
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1
Radboud University Medical Centre Nijmegen
Nijmegen, Gelderland, Netherlands
2
AMC
Amsterdam, Netherlands