A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age

Completed · Phase 1

Conditions studied: Cytomegalovirus Infections, Heart Transplantation

In brief

This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients \< 4 months of age.

Key facts

Study ID

NCT01165580

Run by

Hoffmann-La Roche

People needed

17

Starts

2011-05-01

Expected to finish

2013-09-01

Last updated by the study team

2016-11-02

Who can join

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

You may qualify if…

• Males and females, 0 to < 4 months (< 125 days) of age at the time of the last PK assessment in this study
• Parent or guardian of the patient is willing and able to give written informed consent
• Patient has received a first heart transplant
• Patient is at risk of developing cytomegalovirus (CMV) disease and is being treated with i.v. ganciclovir or oral valganciclovir for prevention of CMV
• Adequate hematological and renal function
• Able to tolerate oral medication (any appropriate form of tube feeding is acceptable)

You may not qualify if…

• Allergic or significant adverse reaction to acyclovir, valacyclovir or ganciclovir in the past
• Severe, uncontrolled, clinically abnormal diarrhea
• Liver enzyme elevation of more than five times the upper limit of normal for AST (SGOT) or ALT (SGPT)
• Patient requires use of any protocol prohibited concomitant medications
• Patient has previously participated in this clinical trial

Where it is running

• Study site — Loma Linda, California, United States
• Study site — Palo Alto, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Atlanta, Georgia, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — St Louis, Missouri, United States
• Study site — The Bronx, New York, United States
• Study site — Durham, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Cleveland, Ohio, United States
• Study site — Charleston, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Dallas, Texas, United States
• Study site — Seattle, Washington, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — Edmonton, Alberta, Canada
• Study site — Madrid, Madrid, Spain
• Study site — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.