N/A
Completed N=14
An Observational Study of Valcyte (Valganciclovir) in D+/R- Liver Transplant Recipients
Cytomegalovirus Infections
Source: ClinicalTrials.gov NCT02062294 ↗
Enrolled (actual)
14
Serious AEs
42.9%
Results posted
Feb 2016
Primary outcomePrimary: Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis — 3 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Developing Cytomegalovirus (CMV) Disease Within 6 Months of Liver Transplantation Under Valcyte Prophylaxis |
3 | — |
| SECONDARY Number of Participants With Any Serious Adverse Events (SAEs) or Adverse Events (AEs) |
6; 10 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT02062294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.