|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT00799071 |
|
Date of registration:
|
26/11/2008 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Pharmacokinetics of Posaconazole in Children With Chronic Granulomatous Disease (CGD)
iPOD |
|
Scientific title:
|
Investigation of POsaconazole Prophylaxis in Children With Chronic Granulomatous Disease (CGD): Pharmacokinetics and Tolerability (iPOD) |
|
Date of first enrolment:
|
February 2009 |
|
Target sample size:
|
12 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT00799071 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Netherlands
|
United Kingdom
| | | | | | |
|
Contacts
|
|
Name:
|
David M Burger, PharmD PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Radboud University Medical Centre Nijmegen |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
2 Years
Age maximum:
16 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Granulomatous Disease
|
|
Intervention(s)
|
|
Drug: posaconazole (PSZ)
|
|
Primary Outcome(s)
|
|
Posaconazole trough levels
[Time Frame: Day 10; 20; 30]
|
|
Secondary Outcome(s)
|
|
adverse events monitoring
[Time Frame: entire study]
|
|
Secondary ID(s)
|
|
UMCN-AKF 08.01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|