A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.

Status:	Completed
Conditions:	Hospital, Pulmonary
Therapuetic Areas:	Pulmonary / Respiratory Diseases, Other
Healthy:	No
Age Range:	14 - Any
Updated:	4/21/2016
Start Date:	December 2004
End Date:	June 2006

Relative Bioavailability Study of Ganciclovir From the Pro-drug, Valganciclovir, in Lung Transplant Recipients With or Without Cystic Fibrosis

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.

Inclusion Criteria:

- male or female patients, >=14 years of age;

- first lung or heart-lung transplant recipient;

- at risk of CMV disease (D+R-,D+R+ or D-R+);

- estimated creatinine clearance >=60mL/min;

- stable immunosuppressive and 900mg Valcyte dosing regimens (>=4 days) prior to
pharmacokinetic assessments.

Exclusion Criteria:

- history of any adverse reaction to acyclovir, valacyclovir, ganciclovir or
valganciclovir;

- evidence of graft rejection;

- patient has received anti-CMV prophylaxis with a treatment other than cytogam,
ganciclovir or valganciclovir between transplant and screening.

We found this trial at

sites

Clinical Trial Facility in Durham North Carolina

Durham, North Carolina

from

Durham, NC