Trial Information

Summary: A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients

Status: Completed

Protocol Number: WV16726

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: An open-label study of the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant patients

Brief Summary: This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100 individuals. Target sample size is 60.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Single Group
  • Endpoints: Safety

Study Type:

Interventional

Condition: Cytomegalovirus infections

Intervention Type: Drug

Intervention Name: valganciclovir [Valcyte]

Primary Outcome: 1. Adverse events, opportunistic infections, dose reductions, interruptions, or discontinuations because of adverse events, adverse changes in hematology and serum chemistry values Time frame: Throughout study

Key Secondary Outcomes: 1. Pharmacokinetic parameters; incidence of CMV viremia and disease Time frame: Throughout study

Inclusion Criteria:

  • patients between 3 months and 16 years of age;
  • first solid organ transplant (eg, kidney, liver, heart);
  • able to tolerate oral medication;
  • females of childbearing potential must agree to utilize an effective method of contraception throughout the study and for 90 days following discontinuation of study drug;
  • patients at risk of developing CMV disease (all transplant recipients other than those who are D-R- for CMV).

Exclusion Criteria:

  • patients who have previously participated in this study;
  • patients who are participating in another clinical trial (except with the approval of the Sponsor);
  • severe, uncontrolled diarrhea (more than 5 watery stools per day);
  • pregnant or lactating females.

Gender: Males or Females

Age Limits: Min: 3 Years Max: 16 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 06/24/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Indianapolis , IN 46202-5124
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: September 2, 2008 at 1:55:44 PM


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