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

Completed · Phase 2/Phase 3

Conditions studied: Cytomegalovirus Infections

In brief

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.

Key facts

Study ID

NCT00090766

Run by

Hoffmann-La Roche

People needed

63

Starts

2004-05-01

Expected to finish

2005-05-01

Last updated by the study team

2016-10-31

Who can join

Age: 0 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — New York, New York, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Parkville, Australia
• Study site — Edmonton, Alberta, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — Paris, France
• Study site — Paris, France
• Study site — Berlin, Germany
• Study site — Guadalajara, Mexico
• Study site — Mexico City, Mexico
• Study site — Madrid, Spain
• Study site — Madrid, Spain
• Study site — Valencia, Spain

Full record on ClinicalTrials.gov

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