Status:
COMPLETED
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
3-16 years
Phase:
PHASE2
PHASE3
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 siz...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT00090766
Start Date
May 1 2004
End Date
May 1 2005
Last Update
October 31 2016
Active Locations (17)
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1
Los Angeles, California, United States, 90095-1752
2
Indianapolis, Indiana, United States, 46202-5124
3
Ann Arbor, Michigan, United States, 48109-0297
4
St Louis, Missouri, United States, 63110