Trial information
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Status: Completed
Protocol number: WV16726
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: An open-label study of the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant patients
Brief summary: 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.
Target sample size is 60.
Study phase: II
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety study
Condition: Cytomegalovirus infections
Intervention type: Drug
Intervention name: valganciclovir [Valcyte]
Primary outcome: 1. Adverse events, opportunistic infections, dose reductions, interruptions, or discontinuations because of adverse events, adverse changes in hematology and serum chemistry values
Time frame: Throughout study
Key secondary outcomes: 1. Pharmacokinetic parameters; incidence of CMV viremia and disease
Time frame: Throughout study
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.
Gender: Males or Females
Age limits: Min: 3 Months Max: 16 Years
Accepts healthy volunteers: No
Trial registration date: 06/24/2005
Date last updated: 10/15/2008
Link to trial result
This trial was conducted at the following locations:
Australia
Canada
France
Germany
Mexico
Spain
United States
- Los Angeles, CA
- Indianapolis , IN
- Ann Arbor, MI
- St Louis, MO
- New York, NY
- Salt Lake City, UT
