Cytomegalovirus Infection Clinical Trial
Official title:
Phase II, Multicentric, Prospective and Opened Clinical Trial of Advance Valganciclovir Treatment of CMV in Allogenic Hematopoietic Progenitors Transplant
PRINCIPAL ENDPOINT To value valganciclovir efficacy in advance treatment of CMV in patients
received allogenic transplant with a uniform treatment.
SECONDARY ENDPOINT To value valganciclovir security in advance treatment of CMV in in
patients received allogenic transplant with a uniform treatment.
The security will be valued by the % of patients that:
Will have negative CMV Neutropenia <1000 neutrophils/mm3 or <500 neutrophils/mm3 in the
first 35 days of treatment - follow-up Renal toxicity in the first 35 days of treatment -
follow-up (defined by elevated creatinine >1mg/dL or twice the basal value) CMV illness
during the treatment or in the next 2 months Blood Antigenemia / PCR positive in the next
2months of treatment
This dates Hill be compared with a patients control group treated with intravenous
valganciclovir
Clinical trial with a drug in new conditions of use ;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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