An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
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This retrospective review will evaluate the efficacy of Valcyte (valganciclovir) in preventing Cytomegalovirus (CMV) disease in D+/R- liver transplant recipients. Data from eligible patients will be collected for the 6 months following transplantation.
Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis [ Time Frame: 6 months ]
Participants with clinical manifestation of CMV disease within 6 months after liver transplantation under Valcyte prophylaxis were evaluated.
Secondary Outcome Measures :
Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs) [ Time Frame: 6 months ]
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
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Layout table for eligibility information
Ages Eligible for Study:
16 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Liver transplant recipients at high risk of developing Cytomegalovirus disease
Liver transplant recipients, >/= 16 years of age
Transplantation between January 2004 and June 2009
CMV seronegative recipient (R-) who received a liver transplant from a seropositive donor (D+)
Valganciclovir therapy for at least 70 days beginning within 10 days post transplantation
Assessment of CMV disease status within the first 6 months post transplantation