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

Cytomegalovirus Infections Clinical Trial

Official title:

An Open-label Study of the Safety and Pharmacokinetics of Valcyte Syrup in Pediatric Solid Organ Transplant Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00090766
• Other study ID #: WV16726
• Status: Completed
• Phase: Phase 2
• First received: September 3, 2004
• Last updated: March 1, 2016
• Start date: May 2004
• Est. completion date: March 2006

Study information

• Verified date: March 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 16 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Infections

Intervention

Drug:
• valganciclovir [Valcyte]
po daily (dose based on body surface area and CrCL)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Mexico,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, opportunistic infections, dose reductions, interruptions, or discontinuations because of adverse events, adverse changes in hematology and serum chemistry values\n\n		Throughout study	No
Secondary	Pharmacokinetic parameters; incidence of CMV viremia and disease\n		Throughout study	No