Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients
NCT ID: NCT00364052
Last Updated: 2006-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
200 participants
OBSERVATIONAL
2006-08-31
2007-01-31
Brief Summary
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There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy.
Alternate Hypothesis:
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.
Detailed Description
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Endpoints:
Primary Endpoint
CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation.
Secondary Endpoints
1. Patient and allograft survival based on donor/recipient CMV status
2. Incidence of graft rejection and loss associated with CMV infection
3. Time to hepatitis C virus (HCV) occurrence
4. Incidence of HSV, EBV and VZV reactivations
5. Severity of HCV occurrence based on biopsy reports based on the Knodell score
6. Safety and tolerability of oral valganciclovir and ganciclovir
Conditions
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Keywords
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Study Design
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DEFINED_POPULATION
OTHER
Interventions
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oral Valganciclovir vs oral Ganciclovir
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients deceased within thirty days of receiving liver allograft
* Patients with low risk of acquiring CMV infection: donor-negative and recipient-negative (D-/R-)
* Patients undergoing re-transplantation
* Lost to follow-up (minimum follow-up is 1 year)
* History of CMV infection or disease
* Anti-CMV therapy within the past 30 d
* Severe, uncontrolled diarrhea or evidence of malabsorption.
18 Years
80 Years
ALL
No
Sponsors
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Oregon Health and Science University
OTHER
Principal Investigators
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Ali J Olyaei, PharmD
Role: PRINCIPAL_INVESTIGATOR
Oregon Health and Science University
Central Contacts
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Other Identifiers
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VAL109
Identifier Type: -
Identifier Source: org_study_id