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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 3, 2004

Last Updated Date

May 13, 2009

Start Date ^†

Current Primary Outcome Measures ^†

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00090766 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Pharmacokinetic parameters; incidence of CMV viremia and disease [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

Official 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.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study

Condition ^†

Cytomegalovirus Infections

Intervention ^†

Drug: valganciclovir [Valcyte]

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

March 2006

Primary Completion Date

Eligibility Criteria ^†

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

Both

Ages

3 Months to 16 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Australia, Canada, France, Germany, Mexico, Spain

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00090766

Responsible Party

Clinical Trials, Study Director, Hoffmann-La Roche

Secondary IDs ^††

Study Sponsor ^†

Hoffmann-La Roche

Collaborators ^††

Investigators ^†

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

Information Provided By

Hoffmann-La Roche

Verification Date

May 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.