The objective of this study is to assess the efficacy and safety of oral valganciclovir versus intravenous ganciclovir in patients following allogenic stem cell transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
212
Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
2x5mg/kg/d intravenous ganciclovir
Pierrel Site 50
Vienna, Austria
Pierrel Site 12
Berlin, Germany
Pierrel Site 13
Berlin, Germany
Efficacy and Safety of oral valganciclovir versus intravenous ganciclovir
Main variable for efficacy in the primary endpoint will be evaluated by assessment of the event-free survival within 180 days after stem cell transplantation. Main variable for safety in the primary endpoint will be evaluated by the porpotion of patients with severe neutropenia until 7 days after discontinuation of antiviral therapy with the study drug.
Time frame: max. 2 years (recruitement time)
Combined secondary endpoint of efficacy and safety
The secondary variables of efficacy will be: The proportion of patients with persistently positive blood specimens for CMV after completion of antiviral therapy with the Study Drug, * The proportion of patients who require retreatment after discontinuation of antiviral therapy with the Study Drug until day 180, * The proportion of patients with CMV disease within 180 days after SCT, * The number of days patients were alive and not hospitalized between randomization and day 180 post SCT, * The proportion of patients who died from any cause within 180 days after SCT.
Time frame: max. 2 years (recruitement time)
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Pierrel Site 9
Bremen, Germany
Pierrel Site 3
Essen, Germany
Pierrel Site 7
Kiel, Germany
Pierrel Site 5
Leipzig, Germany
Pierrel Site 4
Münster, Germany
Pierrel Site 8
Oldenburg, Germany
Pierrel Site 10
Rostock, Germany
...and 7 more locations