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

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00090766

Purpose

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.

Condition	Intervention	Phase
Cytomegalovirus Infections	Drug: valganciclovir [Valcyte]	Phase II

MedlinePlus related topics: Cytomegalovirus Infections

Drug Information available for: Valganciclovir Valganciclovir hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study
Official Title:	An Open-Label Study of the Safety and Pharmacokinetics of Valcyte Syrup in Pediatric Solid Organ Transplant Patients

Further study details as provided by Hoffmann-La Roche:

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 ]

Secondary Outcome Measures:

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

Enrollment:

63

Arms	Assigned Interventions
1: Experimental	Drug: valganciclovir [Valcyte] po daily (dose based on body surface area and CrCL)

Eligibility

Ages Eligible for Study:	3 Months to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00090766

Show 21 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche, +1 973 235 5000

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials, Study Director )
Study ID Numbers:	WV16726
Study First Received:	September 3, 2004
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00090766
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases
Valganciclovir
Cytomegalovirus Infections
DNA Virus Infections

Cytomegalic inclusion disease
Cytomegalovirus
Herpesviridae Infections

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Infection
Antiviral Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009