Trial information
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
Status: Completed
Protocol number: WP18046
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: Relative bioavailability study of ganciclovir from the pro-drug, valganciclovir, in lung transplant recipients with or without cystic fibrosis
Brief 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. Target sample size is
30.
Study phase: I
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Parallel; Pharmacokinetics study
Condition: Cytomegalovirus infections
Intervention type: Drug
Intervention name: valganciclovir [Valcyte]
Primary outcome: 1. AUC and Cmax of ganciclovir. Time frame: At steady state
Key secondary outcomes: None Time frame: None
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.
Gender: Males or Females
Age limits: Min: 14 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- Los Angeles, CA
- Durham, NC
- Cleveland, OH
- Pittsburgh, PA
