Trial Information

Summary: 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 Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Parallel
  • Endpoints: Pharmacokinetics

Study Type:

Interventional

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

Accepts Healthy Volunteers: No

Trial Registration Date: 09/18/2006

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Durham, NC 27710
Telephone: 973-235-5000 or 800-526-6367

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: August 20, 2008 at 2:16:52 PM


Back to Centerwatch Trial Listing by Location


Additional resources
in this illness area

Copyright © 1995 - 2008, CenterWatch
All Rights Reserved

This site was developed in association with Illumina Interactive, Boston, MA