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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01165580
Recruitment Status : Completed
First Posted : July 20, 2010
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment Phase
Cytomegalovirus Infections, Heart Transplantation Drug: valganciclovir [Valcyte] Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Arm Intervention/treatment
Experimental: Single Arm Drug: valganciclovir [Valcyte]
oral dose, Days 1 and 2

Primary Outcome Measures :
  1. Area under plasma concentration versus time curve of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  2. Apparent volume of distribution of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  3. Terminal half-life of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]
  4. Peak concentration of ganciclovir [ Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01165580

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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
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche Identifier: NCT01165580    
Other Study ID Numbers: NP22523
First Posted: July 20, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Cytomegalovirus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Antiviral Agents
Anti-Infective Agents