A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Status:	Completed
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	Any - 16
Updated:	4/21/2016
Start Date:	May 2004
End Date:	March 2006

An Open-label Study of the Safety and Pharmacokinetics of Valcyte Syrup in Pediatric Solid Organ Transplant Patients

This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid
organ transplant recipients. The anticipated time on study treatment is 3-12 months and the
target sample size is less than 100 individuals.

Inclusion Criteria:

- patients between 3 months and 16 years of age;

- first solid organ transplant (eg, kidney, liver, heart);

- able to tolerate oral medication;

- females of childbearing potential must agree to utilize an effective method of
contraception throughout the study and for 90 days following discontinuation of study
drug;

- patients at risk of developing CMV disease (all transplant recipients other than
those who are D-R- for CMV).

Exclusion Criteria:

- patients who have previously participated in this study;

- patients who are participating in another clinical trial (except with the approval of
the Sponsor);

- severe, uncontrolled diarrhea (more than 5 watery stools per day);

- pregnant or lactating females.

We found this trial at

sites

Clinical Trial Facility in St Louis Missouri

St Louis, Missouri

from

St Louis, MO