A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cytomegalovirus Infections, Heart Transplantation
Intervention: valganciclovir [Valcyte] (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
Summary
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.
Clinical Details
Official title: Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Area under plasma concentration versus time curve of ganciclovirApparent volume of distribution of ganciclovir Terminal half-life of ganciclovir Peak concentration of ganciclovir
Secondary outcome: Safety (Incidence of adverse events)
Eligibility
Minimum age: N/A.
Maximum age: 124 Days.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Locations and Contacts
Madrid 28007, Spain
Madrid 28046, Spain
Edmonton, Alberta T6G 1C9, Canada
Loma Linda, California 92354, United States
Palo Alto, California 94304, United States
Aurora, Colorado 80045, United States
Atlanta, Georgia 30322, United States
Ann Arbor, Michigan 48109, United States
Detroit, Michigan 48201, United States
Saint Louis, Missouri 63110, United States
Bronx, New York 10467, United States
Durham, North Carolina 22710, United States
Cincinnati, Ohio 45229, United States
Cleveland, Ohio 44195, United States
Charleston, South Carolina 29425, United States
Nashville, Tennessee 37232-9119, United States
Dallas, Texas 75390, United States
Seattle, Washington 98105, United States
Milwaukee, Wisconsin 53226, United States
Additional Information
Starting date: May 2011
Last updated: August 17, 2015
|