An Assessment of Voriconazole Pharmacokinetics and Pharmacogenetics in Liver Transplant Recipients - Pilot Study
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|ClinicalTrials.gov Identifier: NCT00371605|
Recruitment Status : Terminated (Enrolled requested number of patients and completed study. In analysis)
First Posted : September 4, 2006
Last Update Posted : December 17, 2007
|Condition or disease|
|Liver Transplant Fungal Infection|
All liver transplant patients receiving voriconazole prophylaxis are eligible to participate in this study. We propose a single-center, observational study in 15 liver transplant patients who are admitted to the ICU and receiving voriconazole prophylaxis as part of standard care. Each patient will undergo blood sampling (27 mL) on one occasion (Pharmacokinetic Study I), while receiving oral voriconazole. A small portion of blood (1 mL) collected during this blood sampling period will be retained for genotyping (specific aim III).
Voriconazole prophylaxis is most often administered to liver transplant patients via the oral route (200 mg twice daily). However, circumstances may arise necessitating the administration of intravenous doses of voriconazole for a subset of patients, as part of their standard care. . Thus, these patients will undergo blood sampling on a maximum two additional occasions: 1) surrounding an intravenous dose dose (27 mL) 2) surrounding an oral dose (27 mL) .
The amount of voriconazole present in the blood samples will be measured via high pressure liquid chromatography. Individual plasma concentration time profiles will be determined following oral and intravenous dosing, respectively. Pharmacokinetic parameter estimates will be derived via population and individual pharmacokinetic data analysis.
The use, dose, and frequency of the medication voriconazole is up to the clinical staff. We will not be altering the delivery, dose or use of the drug. Therefore we cannot provide you with the requested information because it will all depend on the clinical team. We are not intervening to enroll subjects. Subjects will only be enrolled if they are placed on voriconazole and they agreed to participate.
|Study Type :||Observational|
|Estimated Enrollment :||15 participants|
|Official Title:||An Assessment of Voriconazole Pharmacokinetics and Pharmacogenetics in Liver Transplant Recipients - Pilot Study|
|Study Start Date :||December 2006|
|Actual Study Completion Date :||April 2007|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00371605
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Blair Capitano, Pharm D||University of Pittsburgh|