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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 ganciclovir

Apparent 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

Page last updated: August 23, 2015

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