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

Roche

Status and phase

Completed

Phase 1

Conditions

Cytomegalovirus Infections

Treatments

Drug: valganciclovir [Valcyte]

Study type

Interventional

Funder types

Industry

Identifiers

NCT00377741

WP18046

Details and patient eligibility

About

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.

Enrollment

31 patients

Sex

All

Ages

14+ years old

Volunteers

No Healthy Volunteers

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.