A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
Status:
Completed
Trial end date:
2006-06-01
Target enrollment:
Participant gender:
Summary
This study will assess the relative bioavailability of ganciclovir from the pro-drug
valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient
will receive 900mg valganciclovir daily for the period specified at their center, starting as
soon as possible after the transplant. Pharmacokinetic assessments will be made provided that
steady-state kinetics of ganciclovir and immunosuppressive drugs have been obtained (>=4 days
of drug therapy). Blood samples for pharmacokinetic analysis will be taken up to 24h
post-dose on one occasion. The anticipated time on study treatment is 3-12 months, and the
target sample size is <100 individuals.