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

Primary Purpose

Chronic Granulomatous Disease

Status

Completed

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

posaconazole (PSZ)

About this trial

This is an interventional prevention trial for Chronic Granulomatous Disease focused on measuring prophylaxis, CGD, pharmacokinetics

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Radboud University Medical Centre Nijmegen
AMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

posaconazole

Arm Description

posaconazole as antifungal prophylaxis

Outcomes

Primary Outcome Measures

Posaconazole trough levels

Secondary Outcome Measures

adverse events monitoring

Full Information

NCT ID

NCT00799071

First Posted

November 26, 2008

Last Updated

November 26, 2020

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00799071

Brief Title

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

Acronym

iPOD

Official Title

Investigation of POsaconazole Prophylaxis in Children With Chronic Granulomatous Disease (CGD): Pharmacokinetics and Tolerability (iPOD)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

February 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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 literature indicating the need for a drug with a broader antifungal spectrum. PSZ might provide in this need. PSZ may also have a clinical safety and tolerability advantage over other antifungal agents. Because PSZ is metabolized through phase II glucuronidation it is less common to be subject to drug interactions. PSZ is known to be a CYP3A4 inhibitor, but does not inhibit other CYP enzymes, therefore it may exhibit fewer drug interactions as compared with other azole antifungal agents. Treatment of children is still off-label use. No data have been published to date on the exposure of PSZ in children under the age of 8 or in children with CGD. There is an urgent need to study the use of PSZ in these young children. Furthermore, the current regimen for antifungal prophylaxis requires a three times daily administration of PSZ. For this specific purpose less complex dosing schedules are warranted thus defining the need to examine a twice daily schedule. As the tolerability and pharmacokinetics are unknown in patients under the age of 8 years and only limited data are available for age groups 8 to 16 years, we propose a feasibility study of a twice daily regimen of PSZ prophylaxis in CGD patients. With this information available we can suggest a dosage for future prophylaxis in this patient group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Granulomatous Disease

Keywords

prophylaxis, CGD, pharmacokinetics

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

posaconazole

Arm Type

Experimental

Arm Description

posaconazole as antifungal prophylaxis

Intervention Type

Drug

Intervention Name(s)

posaconazole (PSZ)

Other Intervention Name(s)

Noxafil

Intervention Description

Intake of PSZ oral suspension 40mg/ml twice daily with food. Starting dose is based on bodyweight. The dosage will be adjusted if the exposure is not adequate based on PSZ trough level on Day 10 and 20.

Primary Outcome Measure Information:

Title

Posaconazole trough levels

Time Frame

Day 10; 20; 30

Secondary Outcome Measure Information:

Title

adverse events monitoring

Time Frame

entire study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M Burger, PharmD PhD

Organizational Affiliation

Radboud University Medical Centre Nijmegen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Radboud University Medical Centre Nijmegen

City

Nijmegen

State/Province

Gelderland

Country

Netherlands

Facility Name

AMC

City

Amsterdam

Country

Netherlands

12. IPD Sharing Statement

Citations:

PubMed Identifier

21772229

Citation

Welzen ME, Bruggemann RJ, Van Den Berg JM, Voogt HW, Gilissen JH, Pajkrt D, Klein N, Burger DM, Warris A. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease. Pediatr Infect Dis J. 2011 Sep;30(9):794-7. doi: 10.1097/INF.0b013e3182195808.

Results Reference

result

Links:

URL

http://journals.lww.com/pidj/Abstract/2011/09000/A_Twice_Daily_Posaconazole_Dosing_Algorithm_for.18.aspx

Description

Pediatr Infect Dis J. 2011 Sep;30(9):794-7. A twice daily posaconazole dosing algorithm for children with chronic granulomatous disease.

Learn more about this trial

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

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