Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease
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ClinicalTrials.gov Identifier: NCT00792246 |
Recruitment Status :
Completed
First Posted : November 17, 2008
Last Update Posted : September 4, 2018
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Graft Versus Host Disease Stem Cell Transplantation | Drug: voriconazole | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Define the Pharmacokinetics of Oral Voriconazole in Children With Extensive Gastrointestinal Graft Versus Host Disease |
Study Start Date : | December 2008 |
Actual Primary Completion Date : | July 2012 |
Actual Study Completion Date : | July 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: graft versus host disease
Patients receiving oral voriconazole will be switched to intravenous voriconazole. Pharmacokinetics will be determined after each formulation.
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Drug: voriconazole
Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care. |
Experimental: No graft versus host disease
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. |
- 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 ]

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.

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): NCT00792246
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 |
Principal Investigator: | P Brian Smith, MD | Duke Unviersity Medical Center |
Responsible Party: | Phillip Brian Smith, Associate Professor of Pediatrics, Duke University |
ClinicalTrials.gov Identifier: | NCT00792246 |
Other Study ID Numbers: |
Pro00004318 |
First Posted: | November 17, 2008 Key Record Dates |
Last Update Posted: | September 4, 2018 |
Last Verified: | August 2018 |
pharmacokinetics pediatric bioavailability |
Graft vs Host Disease Immune System Diseases Voriconazole Antifungal Agents Anti-Infective Agents 14-alpha Demethylase Inhibitors Cytochrome P-450 Enzyme Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Steroid Synthesis Inhibitors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Cytochrome P-450 CYP3A Inhibitors |