Voriconazole Pharmacokinetics in Children With Gastrointestinal Graft Versus Host Disease

NCT00792246 | Completed Phase 1

• 1 other identifier: Pro00004318
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft Versus Host Disease; Stem Cell Transplantation

Keywords

pharmacokinetics; pediatric; bioavailability

Outcome Measures

Primary Outcomes (1)

• Reduced bioavailability of oral voriconazole in pediatric patients status post stem cell transplantation with gastrointestinal graft versus host disease

  one year

Secondary Outcomes (1)

• 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.

  one year

Study Arms (2)

graft versus host disease

EXPERIMENTAL

Patients receiving oral voriconazole will be switched to intravenous voriconazole. Pharmacokinetics will be determined after each formulation.

Drug: voriconazole

No graft versus host disease

EXPERIMENTAL

Patients receiving oral voriconazole will be switched to intravenous voriconazole. Pharmacokinetics will be determined after each formulation.

Drug: voriconazole

Interventions

voriconazole DRUG

Voriconazole formulation will be changed from oral to intravenous at the same dose the subject is currently receiving per standard of care.

graft versus host disease

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Sponsors & Collaborators

• Phillip Brian Smith: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• P Brian Smith, MD

  Duke Unviersity Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: November 13, 2008
• First Posted: November 17, 2008
• Study Start: December 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

US (1)