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

Phase 2

Completed

• Conditions: CGD; 10021429; invasive fungal infection; 10021460; 10017528

• Registration Number: NL-OMON32626
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified