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

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01165580

First received: July 16, 2010

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Cytomegalovirus Infections, Heart Transplantation	Drug: valganciclovir [Valcyte]	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age

Resource links provided by NLM:

MedlinePlus related topics: Cytomegalovirus Infections Heart Transplantation

Drug Information available for: Valganciclovir hydrochloride

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Area under plasma concentration versus time curve of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]
Apparent volume of distribution of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]
Terminal half-life of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]
Peak concentration of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety (Incidence of adverse events) [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	16
Study Start Date:	May 2011
Estimated Study Completion Date:	April 2014
Estimated Primary Completion Date:	April 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Arm	Drug: valganciclovir [Valcyte] oral dose, Days 1 and 2

Eligibility

Ages Eligible for Study:	up to 124 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01165580

Contacts

Contact: Please reference Study ID Number: NP22523 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, California
	Completed
Loma Linda, California, United States, 92354
	Recruiting
Stanford, California, United States, 94305
United States, Colorado
	Not yet recruiting
Aurora, Colorado, United States, 80045
United States, Georgia
	Recruiting
Atlanta, Georgia, United States, 30322
United States, Michigan
	Recruiting
Ann Arbor, Michigan, United States, 48109
	Terminated
Detroit, Michigan, United States, 48201
United States, Missouri
	Recruiting
St. Louis, Missouri, United States, 63110
United States, New York
	Recruiting
Bronx, New York, United States, 10467
United States, North Carolina
	Completed
Durham, North Carolina, United States, 22710
United States, Ohio
	Completed
Cincinnati, Ohio, United States, 45229
	Recruiting
Cleveland, Ohio, United States, 44195
United States, South Carolina
	Recruiting
Charleston, South Carolina, United States, 29425
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States, 37232-9119
United States, Texas
	Completed
Dallas, Texas, United States, 75390
United States, Washington
	Completed
Seattle, Washington, United States, 98105
United States, Wisconsin
	Recruiting
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
	Recruiting
Edmonton, Alberta, Canada, T6G 1C9
Spain
	Recruiting
Madrid, Spain, 28046
	Completed
Madrid, Spain, 28007

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01165580 History of Changes
Other Study ID Numbers:	NP22523, 2010-021172-28
Study First Received:	July 16, 2010
Last Updated:	May 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Valganciclovir

Ganciclovir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013

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