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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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 16, 2010
Last updated: November 1, 2016
Last verified: November 2016
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: Intervention Model: Single Group Assignment
Masking: None (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:

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 ]
  • Apparent volume of distribution of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  • Terminal half-life of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  • Peak concentration of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]

Secondary Outcome Measures:
  • Safety (Incidence of adverse events) [ Time Frame: 9 days ]

Enrollment: 17
Study Start Date: May 2011
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: valganciclovir [Valcyte]
oral dose, Days 1 and 2


Ages Eligible for Study:   up to 124 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01165580

United States, California
Loma Linda, California, United States, 92354
Palo Alto, California, United States, 94304
United States, Colorado
Aurora, Colorado, United States, 80045
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Michigan
Ann Arbor, Michigan, United States, 48109
Detroit, Michigan, United States, 48201
United States, Missouri
Saint Louis, Missouri, United States, 63110
United States, New York
Bronx, New York, United States, 10467
United States, North Carolina
Durham, North Carolina, United States, 22710
United States, Ohio
Cincinnati, Ohio, United States, 45229
Cleveland, Ohio, United States, 44195
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Nashville, Tennessee, United States, 37232-9119
United States, Texas
Dallas, Texas, United States, 75390
United States, Washington
Seattle, Washington, United States, 98105
United States, Wisconsin
Milwaukee, Wisconsin, United States, 53226
Canada, Alberta
Edmonton, Alberta, Canada, T6G 1C9
Madrid, Spain, 28007
Madrid, Spain, 28046
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01165580     History of Changes
Other Study ID Numbers: NP22523
Study First Received: July 16, 2010
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents processed this record on September 21, 2017