Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
|ClinicalTrials.gov Identifier: NCT00364052|
Recruitment Status : Unknown
Verified August 2006 by Oregon Health and Science University.
Recruitment status was: Not yet recruiting
First Posted : August 15, 2006
Last Update Posted : August 17, 2006
There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy.
There exists a significant difference in the incidence of CMV infection when oral valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis to be tested should be defined.
|Condition or disease||Intervention/treatment||Phase|
|Liver Transplantation||Drug: oral Valganciclovir vs oral Ganciclovir||Phase 4|
The objective for this retrospective clinical study is to describe the incidence of CMV infection in orthoptic liver transplant recipients who receive oral valganciclovir or ganciclovir as their CMV prophylactic anti-viral therapy.
CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation.
- Patient and allograft survival based on donor/recipient CMV status
- Incidence of graft rejection and loss associated with CMV infection
- Time to hepatitis C virus (HCV) occurrence
- Incidence of HSV, EBV and VZV reactivations
- Severity of HCV occurrence based on biopsy reports based on the Knodell score
- Safety and tolerability of oral valganciclovir and ganciclovir
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Observational Model:||Defined Population|
|Observational Model:||Natural History|
|Official Title:||Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir|
|Study Start Date :||August 2006|
|Estimated Study Completion Date :||January 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00364052
|Contact: Ali J Olyaei, PharmDemail@example.com|
|Principal Investigator:||Ali J Olyaei, PharmD||Oregon Health and Science University|