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

November 1, 2016 updated by: Hoffmann-La Roche

Pharmacokinetics and Safety of Valganciclovir in Pediatric Heart Transplant Recipients < 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under plasma concentration versus time curve of ganciclovir
Time Frame: 0, 1-3, 3-7, 7-12, 24 hours post-dose
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
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
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
0, 1-3, 3-7, 7-12, 24 hours post-dose

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety (Incidence of adverse events)
Time Frame: 9 days
9 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

July 16, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 20, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NP22523
  • 2010-021172-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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