A Phase 1 interventional study of voriconazole and voriconazole in Graft Versus Host Disease and Stem Cell Transplantation, sponsored by Phillip Brian Smith. Completed at 1 site in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2018-09-04.
Sponsored by Phillip Brian Smith · Phase 1, Interventional, and Treatment
Determine how much voriconazole is absorbed when the product is given by mouth to children with extensive graft versus host disease after a stem cell transplantation and determine the correct dosing of voriconazole in this population.
Hypothesis: Children with gastrointestinal graft versus host disease will have decreased absorption of oral voriconazole and require higher doses of voriconazole in order to prevent or treat fungal infections.
Disseminated fungal infections are a leading cause of mortality in children who receive hematopoietic stem cell transplantation (SCT). Therefore, children routinely receive prophylactic and empirical antifungal therapy after SCT. The most commonly used antifungal agent in this population is voriconazole. Voriconazole can be given via intravenous or oral routes and children who are post SCT are routinely switched from the intravenous to oral formulation at the time of hospital discharge. However, the absorption and systemic exposure of oral voriconazole has not been well-described in children. Furthermore, many children who undergo transplantation develop gastrointestinal graft versus host disease and this likely impacts oral absorption. The magnitude of effect resulting from graft versus host disease on absorption of voriconazole and subsequent blood concentrations in children is unknown. Thus children with graft versus host disease are at a particularly high risk of inadequate absorption with subsequent sub-therapeutic levels of voriconazole. They may need higher or more frequent dosing to achieve therapeutic levels. The purpose of my research project is to define the pharmacokinetics of oral voriconazole and establish dosing guidelines in children following SCT.
806 studies on the registry are indexed under Graft vs Host Disease; 138 are open to participants now.
This study's enrollment of 5 is below the median of 35 across 637 interventional studies indexed under Graft vs Host Disease.
Browse Graft vs Host Disease studies →Phillip Brian Smith is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Patients receiving oral voriconazole will be switched to intravenous voriconazole. Pharmacokinetics will be determined after each formulation.
Drug: voriconazole
Patients receiving oral voriconazole will be switched to intravenous voriconazole. Pharmacokinetics will be determined after each formulation.
Drug: voriconazole
Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care.
Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care.
Reduced bioavailability of oral voriconazole in pediatric patients status post stem cell transplantation with gastrointestinal graft versus host disease
Time frame: one year
Pharmacokinetics(including clearance, maximum concentration, area under the time concentration curve, and half life) of voriconazole in pediatric patients status post hematopoietic stem cell transplantation.
Time frame: one year
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Phillip Brian Smith