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Completed

NCT Number: NCT01165580

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

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.

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Key information

Conditions

Cytomegalovirus Infections, Heart Transplantation Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

Up to 124 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valganciclovir [Valcyte]

Drug

oral dose, Days 1 and 2

Primary outcomes

  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 outcomes

  1. Safety (Incidence of adverse events)

    Time frame: 9 days

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 4 Months of Age

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 20, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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