Status:
COMPLETED
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Cytomegalovirus Infections
Eligibility:
All Genders
14+ years
Phase:
PHASE1
Brief Summary
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis. Each patient will receive 900mg valga...
Eligibility Criteria
Inclusion
- male or female patients, \>=14 years of age;
- first lung or heart-lung transplant recipient;
- at risk of CMV disease (D+R-,D+R+ or D-R+);
- estimated creatinine clearance \>=60mL/min;
- stable immunosuppressive and 900mg Valcyte dosing regimens (\>=4 days) prior to pharmacokinetic assessments.
Exclusion
- history of any adverse reaction to acyclovir, valacyclovir, ganciclovir or valganciclovir;
- evidence of graft rejection;
- patient has received anti-CMV prophylaxis with a treatment other than cytogam, ganciclovir or valganciclovir between transplant and screening.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00377741
Start Date
December 1 2004
End Date
June 1 2006
Last Update
December 31 2015
Active Locations (5)
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1
Los Angeles, California, United States, 90033
2
Denver, Colorado, United States, 80262
3
Durham, North Carolina, United States, 27710
4
Cleveland, Ohio, United States, 44195