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

Hoffmann-La Roche31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cytomegalovirus Infections

Interventions

Eligibility

Sex: ALLMin age: 14 Years

Medical Language ↔ Plain English

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.

Locations (5)

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Denver, Colorado, United States

Unnamed facility

Durham, North Carolina, United States

Unnamed facility

Cleveland, Ohio, United States

Unnamed facility

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Area Under The Observed Plasma Concentration-Time Curve Between Dosing Intervals AUC(0-tau)

The area under the plasma concentration-time curve from time zero to end of dosing interval (AUC \[0-tau\]) is a measure of the plasma ganciclovir concentration from time zero to end of dosing interval. It was computed using the linear trapezoidal rule. The pharmacokinetic parameters of valganciclovir were measured in plasma of all participants following a single oral dose valganciclovir at 900 mg on Day 1.