Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease

Completed · Phase 1

Conditions studied: Graft Versus Host Disease, Stem Cell Transplantation

In brief

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.

Key facts

Study ID

NCT00792246

Run by

Phillip Brian Smith

People needed

5

Starts

2008-12-01

Expected to finish

2012-07-01

Last updated by the study team

2018-09-04

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≤ 18 years, sufficient venous access to permit administration of voriconazole, ability to take oral medications, written informed consent provided by the parent or legally authorized representative, and Grade II or higher (extensive) gastrointestinal graft versus host disease for those patients in the graft versus host disease patient subset.

You may not qualify if…

• History of anaphylaxis attributed to voriconazole or other triazole compounds, any concomitant condition, which in the opinion of the investigator would preclude a patient's participation in the study, or previous participation in this study.

Where it is running

• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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